louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06654661: Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
Official title: Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.


Eligibility criteria: Inclusion Criteria:

* Surgical candidates undergoing primary TKA

Exclusion Criteria:

* Patient is unable to provide written consent

Primary outcomes:
measure: Measured Balance Value of the Medial Side of Knee during TKA
timeFrame: Day 1 (During TKA Procedure)
measure: Measured Balance Value of the Lateral Side of Knee during TKA
timeFrame: Day 1 (During TKA Procedure)
Secondary outcomes:
measure: Range of Motion at Pre-Operative Visit
timeFrame: Baseline
measure: Range of Motion at Post-Operative Visit
timeFrame: Up to Year 2 Post-Procedure
measure: Cases of Revision Surgery
timeFrame: Up to Year 2
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Peter Walker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686061: Blepharospasm Patient Survey for Patients With Blepharospasm
Official title: Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharospasm
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
Collaborators: name: Merz North America, Inc.
First posted: 2012-09-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA treatment.

Brief summary: The purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.

Detailed description: This study is open to males and females \> 18 years and \< 81 years with a clinical diagnosis of blepharospasm.

Eligibility criteria: Inclusion Criteria:

* Male or female subject aged \> 18 years and \< 81 years
* Documented clinical diagnosis of blepharospasm
* Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA

Exclusion Criteria:

* Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles

Primary outcomes:
measure: Botulinum Toxin Treatment Information
timeFrame: This is a single, structured interview about experiences with Botulinum Toxins
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Merz Investigative Site #0007
state: California
city: Sarasota
country: United States
facility: Merz Investigative Site # 0002
state: Florida
city: Boston
country: United States
facility: Merz Investigative Site # 0001
state: Massachusetts
city: Durham
country: United States
facility: Merz Investigative Site #003
state: North Carolina
city: Columbus
country: United States
facility: Merz Investigative Site # 0006
state: Ohio
Study officials:
affiliation: Merz Pharmaceutical, LLC
name: Micki Seoane
role: STUDY_DIRECTOR
References:
Clinical trial NCT03031561: Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality
Official title: Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Microcalcification
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.

SECONDARY OBJECTIVES:

I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).

II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.

III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Eligibility criteria: Inclusion Criteria:

* Give written informed consent
* Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography

Exclusion Criteria:

* Is clinically unstable, severely ill, or moribund

Primary outcomes:
measure: Number of microcalcifications seen on MicroPure ultrasound
timeFrame: Baseline
measure: Number of microcalcifications seen on grayscale ultrasound
timeFrame: Baseline
Secondary outcomes:
measure: Number of microcalcifications determined by pathology findings
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Flemming Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578561: Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
Official title: Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention of Incisional Hernia in Emergency Surgery
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.

Brief summary: Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Detailed description: Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing emergency midline laparotomy

Exclusion Criteria:

* Those with need of concomitant hernia repair.
* Those who received incisions outside the midline.
* Those with delayed abdominal closure.
* Those who died in the immediate postoperative period.
* Those without a minimum 2 years of follow-up.

Primary outcomes:
measure: Incisional hernia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bravo-Salva A, Argudo-Aguirre N, Gonzalez-Castillo AM, Membrilla-Fernandez E, Sancho-Insenser JJ, Grande-Posa L, Pera-Roman M, Pereira-Rodriguez JA. Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study. BMC Surg. 2021 May 18;21(1):243. doi: 10.1186/s12893-021-01243-x.
Clinical trial NCT01774461: Ischemic Preconditioning in Endurance Athletes
Official title: Influence of Remote Ischemic Preconditioning on Cardiac Function After Endurance Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Healthy
* Age between 18 and 65 years
* Endurance-trained (two or more training sessions per week)

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Serum concentrations of cardiac troponins
timeFrame: 6 hours, 2 hourly time intervals
Secondary outcomes:
measure: Indices of cardiac function measured by echocardiography
timeFrame: 2 hours post-exercise
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands
name: Marja van Dieijen-Visser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965561: Performance of Junctional Tourniquets in Normal Human Volunteers
Official title: Performance of Junctional Tourniquets in Normal Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2013-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.

Detailed description: Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.

Eligibility criteria: Inclusion Criteria:

* Adult human volunteers who are recruited, screened, and consent to participate
* Ages at least 18 years old to no more than 60 years old (\<61) on the date of consent
* Male or female
* A worker for the US Military or US Government (active duty military, civilian employees, contractors)

Exclusion Criteria:

* Active-duty military subjects without their supervisor's permission to participate
* Detainees or prisoners
* Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease \[uncontrolled hypertension, heart attack, or arrhythmias\]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
* Pregnancy
* Contracted employees to the US Military or US Government without contractual permission to participate in the research

Primary outcomes:
measure: Effectiveness at Stopping Distal Pulse
timeFrame: 1 min
Secondary outcomes:
measure: Pain During Tourniquet Application
timeFrame: 1 minute
Other outcomes:
Locations:
city: Forts Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: John F Kragh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04070261: Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface
Official title: Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Usability
Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enroll the anesthesiologists and anesthesiology residents in NTUH

Brief summary: Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. As government policy leans towards digitization, the department of anesthesiologist in NTUH collaborates with the information technology office to develop an electronic pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN includes an anesthesia patient list, patient EMR (electronic medical record) and pre-anesthesia assessment form. EVAN was online since March, 2018.

This is an observational research to investigate the user experience and improve the user interface of EVAN.

This research subjects include anesthesiologists from NTUH. This research has three parts: user tasks, questionnaires, and a semi-structured interview. First, the research assistant will record how the user use the App to complete the tasks, which includes video recording and App monitoring. After the tasks is completed, the subject will write a questionnaire. Then the principal investigator will give an interview for feedbacks from the users.


Eligibility criteria: Inclusion Criteria:

* anesthesiologists in NTUH

Exclusion Criteria:

* none

Primary outcomes:
measure: task complete time
timeFrame: the duration the user needs to complete the tasks, usually within 10 minutes
Secondary outcomes:
measure: questionnaire grading
timeFrame: after the user questionnaire completion, usually within 1 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06462261: Phenotypic and Genotypic Characterization of Escherichia Coli
Official title: Phenotypic and Genotypic and Antimicrobial Resistance Characterization of Escherichia Coli Causing Nosocomial Urinary Tract Infections in Sohag University Hospitals ,Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults only with hospital acquired infections

Brief summary: Collection of urine samples Cultivation Antibiotic sensitivity test PCR

Detailed description: Cultivation on MaCconkey and EMB IMVC test Dis diffusion test Detection of virulence and antibiotic resistance genes by PCR

Eligibility criteria: Inclusion Criteria:

- Catheter associated urinary tract infections in patient with catheter more than two 2 days .fever.urine culture with no more than 2 species organisation catheterization .fever.suprapubic tenderness with urine culture more than 105 CFU/Ml

Exclusion Criteria:

* asymptomatic bacteriuria UTI before 48 hrs

Primary outcomes:
measure: Antibiotic sensitivity testing whether sensitive .intermediately sensitive and resistance
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06024161: Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties
Official title: Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Persistent Postsurgical Pain
Arthritis Knee
Arthropathy of Knee
Arthropathy of Hip
Weight Loss
Weight Gain
Obesity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 6400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures from the the Danish National Patient Register by using SKS-code the codes for THA patients will be SKS-code DM16 \[hip osteoarthritis\] + KNFB20 or KNFB30 or KNFB40\[Primary Total Hip Arthroplasty\]. For total knee arthroplasty (TKA), SKS-code DM17 \[knee osteoarthritis\] + KNGB20, KNGB30 or KNGB40 \[primary total knee arthroplasty\]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 \[knee osteoarthritis\] + KNGB01 or KNGB11 \[primary medial unicompartmental knee arthroplasty\].

Brief summary: The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients.


Eligibility criteria: Inclusion Criteria:

- Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution

Exclusion Criteria:

* Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.

Primary outcomes:
measure: Moderate/Severe Persistent Postoperative Pain
timeFrame: 11-15 months postsurgically
Secondary outcomes:
measure: Satisfaction
timeFrame: 11-15 months postsurgically
measure: Willingness to repeat the surgery
timeFrame: 11-15 months postsurgically
measure: Frequent pain
timeFrame: 11-15 months postsurgically
measure: Use of analgaesic
timeFrame: 11-15 months postsurgically
measure: Interference with daily activities
timeFrame: 11-15 months postsurgically
measure: WOMAC pain score
timeFrame: 11-15 months postsurgically
Other outcomes:
Locations:
Study officials:
affiliation: Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
name: Søren Overgaard, MD,DMSc,Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04553783: Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis
Official title: Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 137
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between 19 and 70 years of age with acute pancreatitis, excluding post-ERCP pancreatitis.

Brief summary: This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.

Detailed description: Several scoring systems are used to evaluate the prognosis of acute pancreatitis, but they are rather complicated and clinically less useful. Blood viscosity is associated with hematocrit and inflammatory factors known to be related to the prognosis of acute pancreatitis, and our group's previous study which is not yet published showed that blood viscosity better predicts severe acute pancreatitis than other single factors such as C-reative protein. Therefore, this study aims to prospectively evaluate the usefulness of blood viscosity as a prognostic factor for acute pancreatitis. During the study period, the study is conducted on patients with acute pancreatitis between the ages of 19 and 70, and patients with acute pancreatitis after ERCP are excluded. Blood viscosities at initial and 24 hours after hospitalization, and serum phosphate, which have shown potential as a predictor of severity in post-ERCP pancreatitis in previous studies are measured. The association of these blood biomarkers with the severity of acute pancreatitis will be analyzed and compared with hematocrit, C-reactive protein, etc., which are known as a single prognostic predictor of acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

* Age 19-70 years old
* Acute pancreatitis

Exclusion Criteria:

* Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Primary outcomes:
measure: Prediction of severity of acute pancreatitis using initial blood viscosity
timeFrame: 48hours after admission
Secondary outcomes:
measure: Prediction of severity of acute pancreatitis using blood viscosity change after 24hours
timeFrame: 24hours after admission
measure: Prediction of severity of acute pancreatitis using serum phosphate
timeFrame: 48hours after admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: In Seok Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: