louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03947021: Developing Methods for Reconstructing Electrical Heart Activity
Official title: Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Cardiac Conduction Defect
Keywords: Electrocardiography
Body Surface Potential Mapping
Computational Biology
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.


Eligibility criteria: Overall Inclusion Criteria:

* 18 years or older
* able to provide informed consent
* Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
* Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator

Additional Inclusion Criteria for group 1 (CT group):

- Existing medical indication for a cardiac CT scan unrelated to this research

There are no additional inclusion criteria for group 2 (no-CT group).

Exclusion Criteria:

- Known strong reaction against electrode attachment

Primary outcomes:
measure: Epicardial potentials
timeFrame: Day one, direct measurement
measure: Epicardial electrograms
timeFrame: Day one, direct measurement
measure: Epicardial activation and recovery sequences
timeFrame: Day one, direct measurement
Secondary outcomes:
measure: Disease-specific differences in primary outcome measures
timeFrame: Day one, direct measurement
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
Clinical trial NCT01638221: Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair
Official title: Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who are undergoing a unilateral repair of inguinal hernias laparoscopically

Brief summary: This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

Detailed description: This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene.

The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

Eligibility criteria: Inclusion Criteria:

* over the age of 18
* unilateral side to be repaired
* no major abdominal surgery previously

Exclusion Criteria:

* under age 18
* bilateral repairs undertaken

Primary outcomes:
measure: pain
timeFrame: 1 year
Secondary outcomes:
measure: return to activities of daily living
timeFrame: 1 year
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: GenesysRMC
state: Michigan
Study officials:
affiliation: Ascension Health
name: Adam P Pentel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230321: A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Official title: A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Blood Cancer
Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS)
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2005-09-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.


Eligibility criteria: Inclusion Criteria:- Diagnosis:

* Bone marrow aspirate/biopsy-proven MDS for \> 2 months prior to enrollment.
* MDS French-American-British (FAB) subtypes refractory anemia (RA), RA with ringed sideroblasts (RARS), RA with excess blasts (RAEB), and non-proliferative chronic myelomonocytic leukemia (CMML) \[WBC \< 12,000/ml\].
* Patients must have an untransfused hemoglobin \< 10.0 g/dL and/or patients must be red cell transfusion-dependent for a period of at least 2 months prior to study entry.

  - Laboratory:
* Bilirubin \< or = to 2 mg/dL
* ALT/SGPT \< or = to 2.5 x the upper limit of normal (ULN)
* Normal renal function (Stanford: serum creatinine \< 1.2 mg/dL \[male\], \< 1.0 mg/dL \[female\]; Vanderbilt: \< 1.5 mg/dL).

  * Age: \> or = to 18
  * Other:
* ECOG performance status 0-2.
* Patients may receive standard supportive care, including transfusions and antibiotics as required.
* Patients must be r-HuEPO naive or must not have received prior treatment with r-HuEPO \> or = to 40,000 U/week for more than 4 weeks. Exclusion Criteria:- Patients with secondary MDS or prior allogeneic bone marrow transplant.

Primary outcomes:
measure: hemoglobin and/or red blood cell (RBC) transfusion-dependence.
measure: To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
Secondary outcomes:
measure: To assess bone marrow progenitor BFU-E growth before and after treatment
measure: DARBEPOETIN ALFA
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Peter L Greenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950921: Pilot Testing a Patient Safety Display in the Hospital Setting
Official title: Improving Risk Detection and Communication to Reduce Hospital-Acquired Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Related Infections
Pressure Injury
Keywords: Catheter-Related Infections
Pressure Injury
Patient Safety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-05-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention-control study design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. This intervention, the "Patient Safety Display" will be evaluated in one hospital unit.

Detailed description: This project will introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. A "Patient Safety Display" will be implemented in half of the patient rooms in one hospital unit. The Patient Safety Display will display catheter and pressure injury data pulled real-time from the electronic medical record onto a tablet mounted at the patient bedside.

This is an intervention-control design study that will be conducted with patients and clinicians at Michigan Medicine. The proposed intervention, the Patient Safety Display, will provide clinicians with key catheter and skin information at the bedside when pertinent clinical decisions are being made.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in specific hospital unit of interest or providers caring for patient in that unit

Exclusion Criteria:

* Patients not in unit of interest and providers not caring for patients on that unit

Primary outcomes:
measure: Urinary catheter awareness
timeFrame: 4 months
measure: Central venous catheter awareness
timeFrame: 4 months
measure: Pressure injury awareness
timeFrame: 4 months
Secondary outcomes:
measure: Urinary catheter usage
timeFrame: 4 months
measure: CAUTI
timeFrame: 4 months
measure: Central venous catheter usage
timeFrame: 4 months
measure: CLABSI
timeFrame: 4 months
measure: Pressure injuries
timeFrame: 4 months
measure: Pressure injury care
timeFrame: 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Hospital, Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jennifer Meddings, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544921: Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects
Official title: Phase 1 Study of Anti-glycation Agent GLY-230
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Glycadia
Sponsor class: INDUSTRY
Collaborators: name: University of Florida
First posted: 2007-10-16
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.


Eligibility criteria: Inclusion Criteria:

* Men age 18-55
* Negative drug screen
* Normal EKG, clinical chemistries, CBC, urinalysis, and
* Give written informed consent

Exclusion Criteria:

* Active concomitant serious medical or surgical disease,
* Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days

Primary outcomes:
measure: A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects
timeFrame: October, 2005 to October, 2006
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Univ FL
state: Florida
Study officials:
affiliation: Univ. FLA Gainesville
name: Laurence Kennedy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00734721: Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections
Official title: Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-related Macular Degeneration
Stress
Keywords: intravitreal injection
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: 1. Intravitreal injection can induce perioperative stress for the patients.
2. Different factors can modulate the pre-operative fear and physiologic reaction.

Detailed description: The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Eligibility criteria: Inclusion Criteria:

* First intravitreal injection received ever

Exclusion Criteria:

* No known affective or mental disorder
* Condition does not allow standardized survey

Primary outcomes:
measure: Objective parameters of stress reaction
timeFrame: 12 months
Secondary outcomes:
measure: Subjective Response (state-trate anxiety) in respect of coping behaviour
timeFrame: 12 months
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Eye Hospital
state: BW
Study officials:
References:
Clinical trial NCT06060821: Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Official title: Construct Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Keywords: Exercise test
Spinal stenosis
Physical fitness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.

Brief summary: The aim of this study was to investigate the validity and reliability of the 2 Minute Step Test (2MST) in patients with symptomatic degenerative lumbar spinal stenosis and to explore its correlation with objective assessment methods, namely the 2 Minute Walk Test (2MWT) and the 6 Minute Walk Test (6MWT).

Detailed description: This cross-sectional study will include 55 volunteers aged 18-80 years who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinics and are diagnosed with Lumbar Spinal Stenosis (LSS) through MRI. The demographic characteristics of the patients will be recorded, and their walking distances will be inquired about. The severity of the disease will be determined by examining the levels of stenosis on lumbar MRI scans. All patients will be initially assessed using the 2MST (2-Minute Step Test), 2MWT (2-Minute Walk Test), 6MWT (6-Minute Walk Test), VAS (Visual Analogue Scale), and ODI (Oswestry Disability Index). To measure test-retest reliability, the 2MST will be administered again with a 7-day interval between assessments.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 who have been diagnosed with lumbar spinal stenosis based on magnetic resonance images.

Exclusion Criteria:

* Uncontrolled hypertension
* Decompensated heart failure
* Presence of systemic diseases affecting lower extremity functions
* Presence of degenerative diseases affecting lower extremity functions
* Peripheral artery disease causing vascular claudication
* Psychiatric illness
* Neuromuscular disease
* Pregnancy
* Cognitive impairment

Primary outcomes:
measure: 2-minute step test
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: 6-minute walk test
timeFrame: Baseline and Day 7
measure: 2-minute walk test
timeFrame: Baseline and Day 7
measure: Oswestry Disability Index
timeFrame: Baseline and Day 7
measure: Visual Analogue Scale
timeFrame: Baseline and Day 7
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
name: Nur Kesiktas, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01629121: Prevention of Traumatic Brain Injury in Youth and Adolescents
Official title: Prevention of Traumatic Brain Injury in Youth and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus of Study: Bicycle Helmet Wearing Compliance
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.

Detailed description: The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in-patients in the Children's Medical Center;
* Projected length of stay \>24 hours;
* Mentally and physically fit to complete the educational program;
* History of regular (\>1x per week) bicycle riding;
* All racial/ethnic groups.

Primary outcomes:
measure: parental report of bicycle helmet use
timeFrame: change for baseline in bicycle helmet wearing at 1 and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University, Children's Medical Center
state: Georgia
Study officials:
affiliation: Augusta University
name: Vernon A Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes VA, Maria BL, Caldwell AL, Hopkins I. Prevention of Traumatic Brain Injury in Youth and Adolescents. J Child Neurol. 2013 Nov;28(11):1412-1417. doi: 10.1177/0883073812464272. Epub 2012 Nov 8.
Clinical trial NCT05603221: Renal Perfusion Assessment in the Endovascular Treatment of Renal Artery Stenosis
Official title: Perfusion Assessment Using Arterial Spin Labelling MRI and Flat-panel Detector Parenchymal Blood Volume Imaging in Endovascular Treatment of Renal Artery Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Artery Stenosis
Keywords: renal artery stenosis
renal perfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted in renal artery stenosis patients aged 18 to 80 years with uncontrolled blood pressure or impaired renal function, who were intended for endovascular treatment. CTA, MRA, or Doppler ultrasonography were used for the assessment of the stenosis percentage of renal artery. Subjects with technical failure were excluded in order to reduce the influence of other variables.

Brief summary: The clinical benefits of endovascular treatment in renal artery stenosis remain controversial. This study uses arterial spin labelling MRI and flat-panel detector parenchymal blood volume imaging to observe the change in renal perfusion after endovascular treatment in renal artery stenosis.


Eligibility criteria: Inclusion Criteria:

* patients who provided informed consent
* patients who were diagnosed with RAS by CTA, MRA, or Doppler ultrasonography
* patients who were aged 18 years or older
* patients whose intervened renal arteries were not completely occluded (confirmed by DSA)
* the stenosis percentage exceeding 70%
* patients who had uncontrolled blood pressure or impaired renal function
* paitents whose affected kidney did not have total loss of function

Exclusion Criteria:

* were pregnant
* had a history of renal transplantation or renal artery bypass surgery
* were allergic to iodine contrast medium
* had other contraindications of endovascular treatment
* contraindications of MRI examinations
* had technical failure in the endovascular treatment.

Primary outcomes:
measure: Perfusion of the target kidney assessed by Arterial Spin Labelling MRI
timeFrame: Changes from baseline renal perfusion at 2 months
measure: Perfusion of the target kidney assessed by Flat-panel Detector Parenchymal Blood Volume Imaging
timeFrame: Changes from baseline renal perfusion immediately after endovascular intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: Changes from baseline blood pressure at 1 year
measure: Renal function
timeFrame: Changes from baseline renal function at 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: