louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00548132: Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Official title: Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter-related Bloodstream Infection
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 1088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.

Detailed description: At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.

Eligibility criteria: Inclusion Criteria:

* patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

Exclusion Criteria:

* patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.

Primary outcomes:
measure: The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
timeFrame: 2 years
Secondary outcomes:
measure: Clinical Sepsis Episodes/Per 1000 Catheter Days
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes- Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bernard C Camins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00541632: BacLite Rapid MRSA Clinical Performance
Official title: BacLite Rapid MRSA Clinical Performance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Methicillin Resistance
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2007-10-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 years or older
* Subjects willing to document demographic characteristics
* Subjects willing to have their nose swabbed
* Subjects (or legal representative) willing to sign consent and authorization forms

Exclusion Criteria:

* Subjects who use Vicks Sinex Nasal spray or other nasal sprays
* Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
* Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
* Investigator believes that subject is unsuitable for inclusion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Institute for Medical Research, Inc.
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Wake Forest University
name: Werner E Bischoff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494232: Emergency Management of Minor Blunt Thoracic Trauma
Official title: To Review the Management and Follow-up of Patients With Minor Thoracic Injuries Treated by Emergency Physicians.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Injuries,
Keywords: minor blunt thoracic trauma
physical examination
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-07-10
Enrollment: 186
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 who admitted within the first 6 hours after injury to hospital due to blunt thoracic trauma without concomitant major injury were considered to have minor thoracic trauma and were included in the study

Brief summary: Thoracic traumas are frequent causes of emergency department admissions and the third most common cause of death from trauma. Although emergency management of major thoracic traumas that have high mortality and morbidity were discussed and well-understood in detail in the literature, there are limited information regarding diagnosis, emergency management, treatment and follow-up after discharge of patients with minor blunt thoracic traumas.

The investigators aimed to investigate demographic data, physical examination findings, and the relationship between lung injury, emergency department final diagnosis, hospitalization, discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.


Eligibility criteria: Inclusion Criteria:

* Glasgow Coma Scale (GCS) of 15
* stable vital signs
* admitted within the first 6 hours after injury

Exclusion Criteria:

* urgent and urgent triage category

Primary outcomes:
measure: The incidence of lung injuries caused by minor thoracic traumas will be assessed by using questionnaire.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Emergency
Study officials:
affiliation: Antalya Education and Research Hospital, Department of Emergency Medicine
name: faruk güngör, md
role: STUDY_CHAIR
References:
citation: Shields JF, Emond M, Guimont C, Pigeon D. Acute minor thoracic injuries: evaluation of practice and follow-up in the emergency department. Can Fam Physician. 2010 Mar;56(3):e117-24.
Clinical trial NCT04910932: Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Official title: Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Nuh Naci Yazgan University
First posted: 2021-06-02
Enrollment: 50
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: TREATMENT

Brief summary: It has been reported that in the first stages of the pandemic, a significant portion of the general population experienced psychological problems such as anxiety, depression and post-traumatic disorders. These problems persist today. A balanced diet, physical activity participation and relaxation techniques are recommended for preventing such problems. In studies conducted before the pandemic, it is reported that breathing exercises have positive effects on anxiety, sleep and quality of life in both patients and healthy individuals. Aim of this study is to investigate the effects of breathing exercises applied via teleconference on fear of COVID-19, anxiety, sleep and quality of life in healthy adult population.


Eligibility criteria: Inclusion Criteria:

* volunteering to participate in the study
* having a smart phone that can be used for teleconferencing purposes

Exclusion Criteria:

* have had COVID-19
* hospital admission for suspected COVID-19 in the past week
* having acute respiratory tract infection
* having any diagnosed chronic respiratory, cardiovascular, metabolic or neurological diseases

Primary outcomes:
measure: Fear of COVID-19
timeFrame: Change from baseline at 2nd, 3rd and 4th week
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline at 2nd, 3rd and 4th week
measure: Sleep quality
timeFrame: Change from baseline at 4th week
measure: Health-related quality of life
timeFrame: Change from baseline at 2nd, 3rd and 4th week
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Study officials:
References:
citation: Kepenek-Varol B, Zeren M, Dincer R, Erkaya S. Breathing and Relaxation Exercises Help Improving Fear of COVID-19, Anxiety, and Sleep Quality: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jul;28(7):579-586. doi: 10.1089/jicm.2021.0381. Epub 2022 Apr 25.
Clinical trial NCT00263432: Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Official title: Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Injuries in the Human Knee
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2005-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Important cartilage injury in the knee

Exclusion Criteria:

* Important axis deviation
* Inflammatory joint disorder
* Severe obesity

Primary outcomes:
measure: Healing of the cartilage injuries
timeFrame: After 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Karl Fredrik Almqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889732: A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients
Official title: The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Other Functional Disturbances Following Cardiac Surgery
Postoperative Hemorrhage
Coagulation Defect; Bleeding
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective cardiac surgical patient age 20-80years

Brief summary: Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* cardiac surgical patients using Cardiopulmonary bypass

Exclusion Criteria:

* known coagulation disorder
* Using deep hypothermic circulatory arrest
* Using partial cardiopulmonary bypass

Primary outcomes:
measure: early postoperative bleeding(chest tube drainage)
timeFrame: postoperative bleeding during 6hrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: jonghwan lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: eunhee kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06035432: Accuracy of Digital Models Using Open-access Software Programs
Official title: Trueness and Precision of Digital Models Obtained From Different Open-access Software Programs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Digital Dental Model
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and Oral Radiology Department, Faculty of Dentistry, Alexandria University.

Brief summary: Background: Despite the clear drive toward digital model transformation, there are limitations to some paid software necessary for digital model production. The aim of the study is to compare the accuracy of open-access software against paid software regarding the segmentation process to produce a digital model. Four groups of software programs will be assessed regarding their accuracy in the segmentation process to produce a digital dental model. The reference models will be scanned by a desktop scanner and will be set as the gold standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data will be converted into STL files by four different software programs.


Eligibility criteria: Inclusion Criteria:

* Complete records of patients (upper and lower).
* Intact models with complete anatomy.
* Complete permanent dentition

Exclusion Criteria:

* Broken or damaged stone models.
* Models of patients with orthodontic appliances or dental prosthesis

Primary outcomes:
measure: Deviation in digital models measurments
timeFrame: through study completion, up to 3 months
Secondary outcomes:
measure: Linear measurements
timeFrame: through study completion, up to 3 months
measure: Teeth crown width
timeFrame: through study completion, up to 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
affiliation: Alexandria University, Faculty of Dentistry
name: Noha ElKersh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492632: Ovarian Reserve in Patients With Psoriasis
Official title: Ovarian Reserve in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Anti Mullerian Hormone
Ovarian Reserve
Keywords: psoriasis
Anti mullerian hormone
ovarian reserve
antral follicle count
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be reproductive age women diagnosed with psoriasis. The control population will be aged and BMI matched women without psoriasis.

Brief summary: Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.

Detailed description: Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Almost 75% of patients are diagnosed before the age of 40. There is also increased evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be measured on the 3rd day of the cycle.The serum hormone levels will be compared between women with psoriasis and women without psoriasis

Eligibility criteria: Inclusion Criteria:

* Reproductive age group women: 18-40 years
* Women diagnosed with psoriasis (case group)
* Women without psoriasis (control group)

Exclusion Criteria:

* Women with PCOS (polycystic ovary syndrome)
* history of ovarian surgery
* Body mass index (BMI) over 30
* Women with other autoimmune diseases including Hashitomo thyroiditis
* Women with family history of premature ovarian insufficiency (POI)
* Women with infertility
* Psoriasis using systemic drugs including steroids and immunosuppressive therapy.

Primary outcomes:
measure: to compare serum AMH levels between the two groups
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Research and Training Hospital
Study officials:
affiliation: Kanuni Sultan Suleyman Research and Training Hospital
name: Berna Aslan Cetin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146432: Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
Official title: Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Septicemia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: adexter GmbH
First posted: 2005-09-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock


Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
* Presence of 4 SIRS criteria/indicators
* Suspected or proven infection (refer also to: 1.)
* Age 18-80
* APACHE II score \> 18
* At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)

Exclusion Criteria:

* Suspected or proven pregnancy
* Absolute contraindication for anticoagulation (active bleeding)
* Absolute IgA-deficiency
* History of anaphylactic reaction to egg-albumin
* Participants in other clinical trials (\<12 wks. prior to study inclusion)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine Berlin
Study officials:
affiliation: Charite, University Medicine Berlin, Germany
name: Petra Reinke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25. doi: 10.1097/shk.0b013e31804f5921.
Clinical trial NCT02959632: Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center
Official title: Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalized Patients
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of hospitalized patients.

Detailed description: Animal Assisted Therapy is being provided by the Caring Canines program and is formally available to patients by referrals. In this study, we would like to capture why patients are being referred and to measure the influence of AAT on the symptoms and feelings of patients.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria (Patients):

* Patients admitted to St Mary's or Methodist Hospital and subsequently referred for AAT.
* Subjects undergoing Animal Assisted Therapy as part of their standard care.
* Patients 18-80 years of age.
* Patients who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.

Inclusion Criteria (Care Team Members):

* Care team members of the study participants.
* 18-80 years of age.
* Who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.

Exclusion Criteria:

Exclusion Criteria (Patients):

* Patients with diagnoses of bipolar disorder, schizophrenia or dementia.
* Unable to give consent.
* Pregnant women (as verbalized by participant).

Exclusion Criteria (Care Team Members):

* Care team members of the study participants who do not want to participate.

Primary outcomes:
measure: Number of patients scoring improvement of symptoms using the VAS (visual analogue scale)
timeFrame: Baseline to 45 minutes
Secondary outcomes:
measure: Number of patients scoring improvement of feelings using the VAS (visual analogue scale)
timeFrame: Baseline to 45 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent A Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: