louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05650008: Effects of Intrathecal Local Anesthetics on Left Ventricular Global Longitudinal Strain
Official title: Effects of Intrathecal Local Anesthetics on Left Ventricular Global Longitudinal Strain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Global Cardiac Wall Motion Dysfunction
Keywords: Strain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with no known history of LV dysfunction undergoing elective surgery under spinal anesthesia.

Brief summary: The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE).


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective knee and hip replacements under spinal anesthesia

Exclusion Criteria:

* Patients who do not wish to consent
* Patients with contraindications to TTE
* Patients with reduced left ventricular systolic function as defined by LV ejection fraction \< 50% on pre-operative echocardiography
* Patients with body mass index greater than 40
* Non-English-speaking subjects
* Cognitively impaired adults

Primary outcomes:
measure: Left Ventricular Global Longitudinal Strain
timeFrame: 5 minutes
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06079008: The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Official title: The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Diabetic Foot
Valve Disease, Aortic
Valve Heart Disease
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery between July 2017 and March 2021 and were followed up for 1 year after amputation surgery

Brief summary: The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients. Diabetic patients requiring lower-extremity amputation were retrospectively studied. Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using echocardiography at baseline. One-year follow-up was conducted and included clinical visits, hospital record assessment, and telephone reviews to obtain the survival status of patients. Researchers compare the survival group to the mortality group to study the relationship between the cardiac valve calcification and mortality.

Detailed description: This study aimed to investigate the association between cardiac valve calcification and 1-year mortality in diabetic patients after lower-extremity amputation. The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery. Clinical characteristics of each patient and the laboratory examination were collected before surgery. Cardiac valve calcification was assessed at baseline. This study obtained the survival status of patients within one year through outpatient follow-up and telephone follow-up. Researchers compared the survival group to the mortality group to see if the mortality group had a higher prevalence of heart valve calcification.

Eligibility criteria: Inclusion Criteria:

* Had echocardiography at baseline
* With diabetic foot ulcers that required amputation after orthopedist's assessment

Exclusion Criteria:

* Fractures due to traumatic reasons that required extremity amputation
* Amputation level below the ankle
* Severe sepsis that required vasoactive agent treatment
* Rheumatic heart disease
* Heart valve surgery history

Primary outcomes:
measure: The proportion of cardiac valve calcification between survival group and mortality group
timeFrame: 2017-12-1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01781208: Ultrasound Based Acoustic Radiation Force Impulse Imaging
Official title: Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Liver Inflammation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 62
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

Detailed description: A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or younger
* Scheduled to have a needle biopsy of the liver at

  1. C.S. Mott Children's Hospital or
  2. Dept. of Radiology at the Univ. of Michigan Hospital
* Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

Exclusion Criteria:

* None to list

Primary outcomes:
measure: ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Jonathan Dillman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824508: Position of Teamleader and Leadership Performance
Official title: Effect of the Position of the Teamleader on Quality of Leadership and Team Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leadership
Keywords: simulation
cardiopulmonary resuscitation
teamleader
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 151
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Investigation in simulated cardiac arrests. Team leaders are randomly designated. Designated teamleaders are instructed to lead their team from the position of the patient's head or remote from the patient.

Detailed description: participants: physicians taking part in voluntary simulator-based workshops. Teams of 3-4 are formed. One teammember is randomly allocated as teamleader design: prospective, randomized, single-blind, cross-over intervention: teamleaders are randomized and instructed to lead their team from the conventional position at the patient's head or from a remote hands-off position data analysis: will be performed from videorecordings

Eligibility criteria: Inclusion Criteria:

* Physicians taking part in voluntary workshops

Exclusion Criteria:

* refusal to participate and/or being videorecorded

Primary outcomes:
measure: Quantity of leadership
timeFrame: 5 minutes
Secondary outcomes:
measure: Hands-on time
timeFrame: 5 minutes
measure: Quality of leadership
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Stephan Marsch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646008: Correlation Between Carbon Dioxide Measured in End of Exhalation and Arterial Blood
Official title: Correlation Between Carbon Dioxide Measured in End of Exhalation and Arterial Blood in Chronic Obstructive Pulmonary Disease (COPD) in Intensive Care Unit With Nasal Cannula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correlation Between Exhaled Carbon Dioxide and in Arterial Blood
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult COPD patients admitted to the ICU who consent

Brief summary: The purpose of this study is to study the correlation between carbon dioxide measured by capnography at the enf of exhalation and arterial blood in COPD patients with nasal cannula in critical care unit.


Eligibility criteria: Inclusion Criteria:

* Adults
* COPD patients

Exclusion Criteria:

* Under-aged
* Pregnant
* Major burns

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe, Spain
name: Susana Arias-Rivera, Graduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05605808: Aerobic Training and Diet on the Immune System in Postmastectomy Patients Receiving Chemotherapy
Official title: Impact of Aerobic Training Combed With Diet Protocol on Immune System in Post Mastectomy Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Deficiency
Diet, Healthy
Breast Cancer
Keywords: Aerobic exercises
Diet therapy
Immune function
Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The model is composed of the aerobic and diet protocol group (Group A), the diet protocol group (Group B), and the aerobic training group (Group C).
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy.

Detailed description: Chemotherapy reduces circulating lymphocytes levels, which affect lymphocytes in breast cancer patients during the therapy itself or up to 3 months after the last chemotherapy cycle, so the study is developed to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy. Sixty post-mastectomy women were receiving chemotherapy and aged from 40-60 years selected from the outpatient clinic of the oncology department in the New Cairo hospital in the Police Academy. They will be assigned randomly into three equal groups, the aerobic exercises and diet protocol group, the diet protocol group, and the aerobic exercises group. The immunological markers; total lymphocyte count (TLC), neutrophil-to-lymphocyte ratio(NLR), and platelet-to-lymphocyte ratio(PLR) will be measured at baseline and after twelve weeks of intervention.

Eligibility criteria: Inclusion Criteria:

* Female post-mastectomy patients.
* Age range is between 40-60 years old.
* All patients will enter the study after having their informed consent.
* All patients are undergoing chemotherapy treatment with AC protocol (Adriamycin with endoxan) for four cycles (every 21 days ).
* All patients have finished the first stage of chemotherapy treatment

Exclusion Criteria:

* Cardiac disease patients.
* Uncontrolled hypertension patients.
* Patients with thyroid disease.
* Patients with lymphatic complications.

Primary outcomes:
measure: The change in total lymphocyte count.
timeFrame: Baseline and twelve weeks after the intervention.
measure: The change in neutrophil to lymphocyte ratio.
timeFrame: Baseline and twelve weeks after the intervention.
measure: The change in platelet to lymphocyte ratio.
timeFrame: Baseline and twelve weeks after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed Elsayeh
state: New Cairo
Study officials:
affiliation: Cairo University
name: Shaimaa MA Elsayeh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00905008: Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry)
Official title: Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stent Thrombosis
Keywords: drug-eluting stent
bare-metal stent
long-term safety
mortality
stent thrombosis
Angioplasty
Transluminal
Percutaneous Coronary
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 1502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: FRIST (FReIburger STent) is a single-centre, long-term stent registry in a high volume tertiary referral cardiovascular centre. FRIST included patients treated with drug-eluting stents and uncoated stents at the University Hospital of Freiburg, Germany, according to non-restrictive inclusion criterions, in which virtually all consecutive patient subsets were considered eligible.

Brief summary: The FReIburger STent Registry (FRIST) is designed to determine the long term safety and efficacy of Drug Eluting Stents (DES) in a "real-world" patient population requiring stent implantation.

FRIST included patients treated with DES and bare-metal stents (BMS) in the University Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing percutaneous coronary intervention

Exclusion Criteria:

* Patient refusal or inability to provide written informed consent

Primary outcomes:
measure: All cause mortality (cardiac- and non-cardiac death).
timeFrame: 5 years
Secondary outcomes:
measure: The composite of death and MI and stent thrombosis.
timeFrame: 5 years
measure: The occurrence of TVR, stroke, major bleeding, sepsis and tumor were also assessed.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Freiburg
name: Thorsten Grumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kersting S, Grumann T, Hummel J, Hauschke D, Bode C, Hehrlein C. Impact of chronic kidney disease on long-term clinical outcomes after percutaneous coronary intervention with drug-eluting or bare-metal stents. Crit Pathw Cardiol. 2012 Sep;11(3):152-9. doi: 10.1097/HPC.0b013e31825d267a.
Clinical trial NCT02481908: STI Combined to Valsalva Maneuver for the Diagnosis of Left Ventricular Dysfunction in COPD Exacerbations
Official title: a New and Non Invasive Method to Calculate STI ( Systolic Time Intervals) Combined to Valsalva Maneuver in Patient With Acute Exacerbation of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Chronic Bronchitis With Acute Exacerbation
Keywords: AECOPD
left ventricular dysfunction
valsalva maneuver
systolic time intervals
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is a prospective study of patients visiting the emergency department of the hospital Fattouma Bourguiba Monastir with decompensated chronic obstructive pulmonary disease COPD

Brief summary: The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the emergency department for cute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs measured under Valsalva manoeuver (VM) could improve the distinction between patients with LVD and those without LVD.

Detailed description: We included patients admitted to the ED for AECOPD. Measurement of STIs included electromechanical activation time (EMAT), left ventricular ejection time and EMAT/LVET ratio. These were performed at baseline and during the first strain phase of the VM using a computerized phono and electrocardiographic method. The diagnosis of LVD was determined on the basis of clinical examination, echocardiography and brain natriuretic peptide. The values of STIs were compared between patients with and without LVD ; their diagnostic performance was assessed using the area under receiver operating characteristic curve (AUC of ROC).

Eligibility criteria: Inclusion Criteria:

* Oxygen Saturation (SPO2) \<90%,
* Respiratory Rate \>25c/min,
* PaCO2 \> 6 kPa et pH\< 7.35.

Exclusion Criteria:

* Neurological distress and hemodynamic instability
* Confusion, agitation
* pneumothorax
* Non cooperative patients
* Refusal of consent

Primary outcomes:
measure: diagnosis of left ventricular dysfunction
timeFrame: during the first day admission in emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU Fattouma Bourguiba
Study officials:
affiliation: Fattouma Bourguiba University Hospital
name: SEMIR NOUIRA, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03637608: Proximal Humerus Fractures: A Retrospective Analysis
Official title: PROXIMAL HUMERAL FRACTURES: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Proximal Humeral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proximal Humeral Fracture
Lead sponsor: The Orthopaedic Research & Innovation Foundation
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients of the principal investigator receiving open reduction internal fixation of the proximal humerus for any indication at St. Elizabeth Healthcare on or after January 1, 2010 will be evaluated and included in the data analysis.

Brief summary: The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. open reduction internal fixation surgical management of a proximal humeral fracture

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
3. Greater Tuberosity Fractures

Primary outcomes:
measure: total operative time
timeFrame: preoperative to up to 8 years postoperative
measure: amount of blood loss
timeFrame: preoperative to up to 8 years postoperative
Secondary outcomes:
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
measure: Patient Outcomes
timeFrame: preoperative to up to 8 years postoperative
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: The Orthopaedic Research & Innovation Foundation
state: Kentucky
Study officials:
affiliation: The Orthopaedic Research & Innovation Foundation
name: R M Greiwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740908: Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments
Official title: Pilot Study for the Detection of Stem/Progenitor Cell Up-regulation Using Aldagen BRIGHT Technology in Peripheral Blood After Hyperbaric Oxygen Therapy (HBOT) Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Changes in Peripheral Blood Population Numbers and Type.
Keywords: hyperbaric oxygen
stem cell
Lead sponsor: Restorix Research Institute, LLLP
Sponsor class: OTHER
Collaborators: name: Cytomedix
name: Island Hospital
First posted: 2012-12-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will reflect the racial and ethnic distribution that exists in the Anacortes metropolitan region.

B- Skagit County, WA: White (91.4%), Black (0.9%), American Indian (2.6%), Asian or Pacific Islander (2.3%), Other (2.8%)

Brief summary: This is an observational research study whose purposes are to see the effects of repeated hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than air at sea level. In this research, the concentration of oxygen will be twice the level of oxygen at sea level.


Eligibility criteria: Inclusion Criteria:

Patients recruited will be healthy volunteers with no current, ongoing infection or chronic disease.

Exclusion Criteria:

We will exclude or delay the treatment if our patients have an active lung infection, develops cancer, if the patient cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety. Any patient that cannot breathe without a respirator will be excluded.

Primary outcomes:
measure: Peripheral blood analysis of circulating stem cells
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anacortes
country: United States
facility: Restorix Wound Treatment Center at Island Hospital
state: Washington
Study officials:
References:
citation: Thom SR, Bhopale VM, Velazquez OC, Goldstein LJ, Thom LH, Buerk DG. Stem cell mobilization by hyperbaric oxygen. Am J Physiol Heart Circ Physiol. 2006 Apr;290(4):H1378-86. doi: 10.1152/ajpheart.00888.2005. Epub 2005 Nov 18.