louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02001753: Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Official title: Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 88
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical diagnostic imaging tool. By using a static and a gradient magnetic field in combination with a radiofrequency field (RF), MR provides excellent contrast among different tissues of the body. Although long-term effects on human health from exposure to strong static magnetic fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure, reversible arrhythmia, and neurobehavioural effects have been documented from occupational exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest switching electromagnetic gradients available in MR exposing the patients to the highest administered energy levels accepted by the controlling authorities. Studies focusing on experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since CMR is emerging as one of the fastest growing new fields of broad MR application, it is of particular concern that a recent in vitro study with CMR sequences has reported on CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR. Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial progenitor cells in type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male
* Age 30 to 65 years old
* Type 2 diabetes

Exclusion Criteria:

* Renal and liver function dysfunction
* Heart failure
* Malignancy
* Patients with contraindications to cardiac magnetic resonance (CMR)
* Patients with clinical detectable angiopathy

Primary outcomes:
measure: Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes
timeFrame: 3 days
Secondary outcomes:
measure: Changes of endothelial progenitor cells before and after CMR in peripheral blood
timeFrame: 3 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Guangda Xiang
state: Hubei
Study officials:
References:
citation: Xiang G, Xiang L, He H, Zhang J, Dong J. Impact of cardiac magnetic resonance on endothelial function in type 2 diabetic patients. Atherosclerosis. 2015 Mar;239(1):131-6. doi: 10.1016/j.atherosclerosis.2014.12.028. Epub 2015 Jan 13.
Clinical trial NCT03349853: Description of the Use of Subcutaneous Acetaminophen in Palliative Care Unit in France: Descriptive Questionnaire Survey
Official title: Description of the Use of Subcutaneous Acetaminophen in Palliative Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Palliative care; Acetaminophen; Subcutaneous route; Pain treatment
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: doctors responsible for palliative care unit in France

Brief summary: Acetaminophen is a drug commonly used in palliative care unit, for its antalgic and antipyretic effects. Several administration routes are possible but the use of the sub-cutaneous route is actually not supported by recommandations.


Eligibility criteria: Inclusion Criteria:

* doctors responsible for palliative care unit in France

Exclusion Criteria:

-

Primary outcomes:
measure: knowledge about the use of subcutaneous acetaminophen in palliative care unit.
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00224653: Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Reduced Lung Compliance.
Anesthesia.
Laparoscopy.
Keywords: Obesity.
Respiration. Respiration, artificial.
Ventilation. Pressure controlled. Volume controlled.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 36
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: To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI \> 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.

Detailed description: All patients are over 18 years old and give their inform consent after approval of the study protocol by an ethic committee. Anesthesia is standardized and all patients are intubated. Precise protocols are used to perform pressure and volume controlled ventilation in order to regulate End-Tidal CO2 between 33 and 35 mmHg. Primary goal is comparison of plateau pressures observed in the 2 ventilation modes after 45 minutes of pneumoperitoneum. Secondary goals are : comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.

Eligibility criteria: Inclusion Criteria:

* patients are over 18 years old and give their inform consent
* morbid obesity(BMI\>35)
* laparoscopic bariatric surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Plateau pressures generated by mechanical ventilation after 45 minutes of pneumoperitoneum.
Secondary outcomes:
measure: Comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges Pompidou European Hospital
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe CADI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
Clinical trial NCT01359553: Clinical Study of Novel Diagnostic Techniques for Knee Osteoarthritis
Official title: Comparison Between Intra-articular Ultrasound Imaging, Non-invasive Ultrasound Imaging, Quantitative MRI Imaging, Contrast-enhanced CT Imaging and Arthroscopy for Diagnostics of Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Knee Injuries
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: University of Eastern Finland
name: Kuopio University Hospital
First posted: 2011-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from those referred to an arthroscopy because of pain symptoms in the knee.

Brief summary: The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.


Eligibility criteria: Inclusion Criteria:

* Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI
* Age \>= 20 years

Exclusion Criteria:

* Tumor or inflammation in the knee
* Severe general diseases
* Diabetes

Primary outcomes:
measure: Arthroscopical OA grade
timeFrame: 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu and Oulu University Hospital
name: Simo Saarakkala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu and Oulu University Hospital
name: Petri Lehenkari, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Oulu and Oulu University Hospital
name: Miika T Nieminen, Ph.D.
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Risto Ojala, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04184453: Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients
Official title: Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Aceruloplasminemia
Keywords: Aceruloplasminemia
Deferiprone
Pancreas MRI
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 5
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
Intervention model description: Patients who was diagnosed as aceruloplasminiaemia
Primary purpose: TREATMENT

Brief summary: Aceruloplasminemia is an autosomal recessive disorder characterized by iron deposition in the brain and visceral organs. Deferiprone was used to treat aceruloplasminemia in previous study. In this study, we will assess the clinical curative effect evaluation of oral deferiprone in Chinese aceruloplasminemia patients.

Detailed description: Diabetes is one of the most severe symptom in aceruloplasminemia. In this study, we use R2\* of pancreas MRI to evaluate the effect of deferiprone treatment.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Diagnosed with aceruloplasminaemia
* Genetically confirmed diagnosis of aceruloplasminaemia

Exclusion Criteria:

* Contraindications to deferiprone therapy
* Pregnancy was excluded in women of childbearing age

Primary outcomes:
measure: Change of pancreas MRI
timeFrame: Up to 3 months
measure: Change of glycated hemoglobin (HbA1c)
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology , First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
affiliation: Department of Neurology , First Affiliated Hospital Fujian Medical University
name: Wanjin Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598753: Combined Behavioral and Analgesic Trial for Fibromyalgia
Official title: Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 134
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls.

Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society.

There are 4 possible study treatment combinations:

1. Tramadol + CBT,
2. Tramadol + HE,
3. Placebo + CBT,
4. Placebo + HE.

Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.


Eligibility criteria: Inclusion Criteria:

* Males and Females 21-70
* Diagnosis of Fibromyalgia
* Current primary care physician
* Fluent in English

Exclusion Criteria:

* Rheumatologic disorders
* Drug and alcohol abuse in the past year
* Psychiatric hospitalization in the past 6 months
* Current use of Tramadol
* Certain antidepressant and other pain medications

Primary outcomes:
measure: Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
timeFrame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT01303653: Endoscopic Treatment of Intestinal Fistulas and Perforations
Official title: Endoscopic Treatment of Intestinal Fistulas and Perforations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastrointestinal Fistula
Gastrointestinal Perforation
Keywords: endoscopic tissue closure,
gastro-gastric fistulas,
gastrointestinal perforations
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.

Detailed description: Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.

Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.

Eligibility criteria: Inclusion Criteria:

* Gastrointestinal fistula and perforation
* Ability to undergo general anesthesia
* Ability to give informed consent

Exclusion Criteria:

* Contraindicated for esophagogastroduodenoscopy (EGD)
* Contraindicated for colonoscopy
* BMI ≥ 40
* Presence of esophageal stricture
* Altered gastric anatomy
* Intraabdominal abscess or severe inflammation

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Good Samaritan Hospital, Legacy Health System
state: Oregon
Study officials:
References:
Clinical trial NCT04151953: Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Official title: Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging (MRI)
Keywords: Pacemaker
Implantable Cardioverter Defibrillator (ICD)
Cardiac implantable electronic device (CIED)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 105
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: Adult males and females age 18 and above identified from the electronic medical record (EMR) calendar of patients with devices who are coming for a MRI

Brief summary: Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).

Detailed description: With an aging population and growing indications for both MRI and CIEDs, it is estimated that patients with a CIED will have up to a 75% likelihood to meet some indication for MRI during their lifetime. MRI in patients with CIEDs has been increasingly shown to be a viable option in a variety of clinical circumstances under strict protocols and close monitoring. It is uncertain if MRI results in myocardial injury. Injury could occur due to heating of the lead(s) with myocardial heating and injury occurring at the lead tip.

A previous Mayo study published in 2016 showed no significant changes in cardiac troponin levels in the majority of patients with a CIED when MRI was performed. This study however was done using the older, less sensitive troponin assay. Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its increased sensitivity. The previous Mayo study was also a retrospective study, and thus the data gathered was not as rigorously controlled as might be ideal.

Eligibility criteria: Inclusion Criteria:

* Patients who have CIED devices (whether conditional or unconditional, regardless of the type of device e.g. ICD, pacemakers, leadless pacemakers) who undergo MRI for any reason

Exclusion Criteria:

* Patients under age 18
* Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
* Pregnant patients
* Patients who cannot provide informed consent because of cognitive dysfunction

Primary outcomes:
measure: Myocardial injury
timeFrame: Baseline, 6-24 hours post MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Allan S Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460953: Use of a Training Video to Teach Medical Students About Health Literacy
Official title: Use of a Training Video to Teach Medical Students About Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: curriculum
training
Medical student Knowledge
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training video on the topic of health literacy for medical students.
2. Briefly summarize how participants are recruited: OHSU medical students attending mandatory trainings on the topic of health literacy during the 1st and 2nd years of medical school will be invited to participate in the study.
3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after viewing a 23-minute video about health literacy.
4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. The investigators will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time.


Eligibility criteria: Inclusion Criteria:

* 1st-year medical student at OHSU

Exclusion Criteria:

Primary outcomes:
measure: Change in knowledge
timeFrame: immediately following the intervention, and at 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU School of Medicine
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Clifford A Coleman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: