louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01492855: Evaluation of MRI Diagnosed Meniscal Lesions
Official title: The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus Lesion
Keywords: Meniscal lesions
MRI
arthroscopic treatment
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The knee menisci are two semicircular fibrocartilaginous structures located between the articular cartilage surfaces of the femur and tibia in the medial and lateral joint compartments. The main functions of the menisci are shock absorption and load transmission in the knee, mainly through distribution of mechanical stress over a large area of the joint cartilage.

The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline are associated with poorer outcome.

Detailed description: Meniscal lesions are the most common source of disability of the knee with a reported incidence rate of up to 18 meniscal lesions per 10.000 subjects per year in Denmark. The meniscus may tear as a result of knee trauma or it may tear spontaneously due to aging and degenerative processes. Magnetic resonance imaging (MRI) is increasingly used in the diagnosis of meniscal lesions with documented high sensitivity and specificity. Meniscal lesion symptoms vary from reduction in knee function with decreased muscle strength and difficulties in performing strenuous activities involving knee flexion and rotation to pain, effusion locking and, giving way.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of meniscal lesion according to pain on weight-bearing activities, locking, normal stability, tenderness at medial and/or lateral joint line, normal X-ray
* Age \> 18 years
* Able to understand Danish
* Able to sign an informed consent

Exclusion Criteria:

* Age \< 18 years
* Unable to understand Danish
* Unable to sign an informed consent
* Unstable knee
* X-ray or MRI that shows other diagnoses

Primary outcomes:
measure: Investigation of improvement in KOOS subscale pain and symptoms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Ole Simonsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05114655: Aromatherapy for Stress and Burnout Among Healthcare Providers
Official title: The Effects of Aromatherapy on Stress and Burnout Among Healthcare Providers During the COVID-19 Pandemic: A 3-Arm Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Burnout, Professional
Stress, Job
Keywords: aromatherapy
essential oils
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the potential for inhalation of plant-based aromas to reduce stress and burnout among healthcare professionals and staff in hospitals and urgent care centers.

Detailed description: After being informed about the study and potential risks/benefits, participants will provide e-sign informed consent documents and be randomized to one of three groups in a 1:1:1 ratio. Each participant will apply the assigned study oil to the jawline for inhalation three times daily for a total of 7 days.

Eligibility criteria: Inclusion Criteria:

* Age 20-59
* Lives in the United States
* Otherwise healthy
* Employed full time in a capacity that interacts with patients at a hospital, primary, or urgent care center that treats COVID-19 patients. Full time is defined as 35 hours or more each week.

Exclusion Criteria:

* Positive COVID-19 test within 60 days of the study period
* COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
* Allergy to any of the ingredients
* Regular smokers in the home (daily or more often)
* Pregnant, trying to conceive, or breastfeeding
* Existing use of an aromatherapy blend for stress management

Primary outcomes:
measure: Post-intervention score on the Maslach Burnout Inventory for Health Personnel on day 7
timeFrame: Day 7
measure: Post-intervention score on the Profile of Mood States, abbreviated version on day 7
timeFrame: Day 7
measure: Post-intervention score on the Depression Anxiety Stress Scale (DASS) on day 7
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
References:
Clinical trial NCT02452255: Fenofibrate and Propranolol in Burn Patients
Official title: Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Shriners Hospitals for Children
First posted: 2015-05-22
Enrollment: 18
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.

Detailed description: Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* 0 through 80 years
* ≥ 20% Total Body Surface Area Burn injury

Exclusion Criteria:

Pregnancy

History or existence of pre-burn injury conditions

* Allergies to propranolol or fenofibrate
* Asthma requiring treatment
* Congestive heart failure (measured ejection fraction \< 20%)
* Renal or hepatic disease
* Medical condition requiring glucocorticoid treatment
* History of AIDS, Aids Related Complex or HIV
* History of Cancer within 5 years

Decision not to treat due to burn injury severity or futility as deemed by the clinical team

Primary outcomes:
measure: Glucose Metabolism
timeFrame: From randomization up to one year
Secondary outcomes:
measure: Hypermetabolism
timeFrame: From randomization up to one year
measure: Rate pressure product
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Shriners Hospitals for Children
state: Texas
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05292755: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
Official title: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to modify the gut microbiome. The study is examining its effects on the eye microbiome, which may have implications on ocular disease and artificial tear choice. The study will administer artificial tears containing CMC to the treatment group and artificial tears without CMC to the control group. Surveys and conjunctival swabs will be collected before and after treatment for bacterial genome sequencing and analyzed by R statistical packages.


Eligibility criteria: Inclusion Criteria:

* Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.

Exclusion Criteria:

* Individuals with active eye infections or have prosthetic eyes.
* Are immunocompromised, or are diagnosed with autoimmune diseases or malignant neoplasms about the eye.
* Individuals who take immunomodulatory therapy, steroids, antibiotics, medicated eyedrops, or are already using CMC eyedrops within 1 week of the study will also be excluded.

Primary outcomes:
measure: Species Richness
timeFrame: Assessed at day 1 and day 7, day 7 reported.
measure: Species Diversity
timeFrame: Assessed at day 1 and day 7, day 7 reported.
measure: Beta Diversity (Unweighted UniFrac)
timeFrame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
measure: Beta Diversity (Weighted UniFrac)
timeFrame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Secondary outcomes:
measure: Ocular Surface Disease Index Score
timeFrame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
measure: Artificial Tear Use
timeFrame: Assessed at day 7
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Oaks Eye Center
state: Florida
Study officials:
affiliation: University of Florida
name: Yujia Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155955: Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A
Official title: Comparison of Outcomes Between Low Dose Emicizumab and Extended Half-life Factor VIII With Pharmacokinetic-guided Prophylaxis in Clinically Severe Hemophilia A
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Severe Hemophilia A Without Inhibitor
Joint Bleed
Keywords: emicizumab
hemophilia A
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 15
Sex: MALE
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration
* To study pharmacokinetic, side effect of low dose Emicizumab

Detailed description: * To compare outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration using ABR, AJBR and HJHS, HaemoQoL
* To study pharmacokinetic, side effect and effectiveness of low dose Emicizumab

Eligibility criteria: Inclusion Criteria:

* Severe or moderate Hemophilia A with baseline FVIII:C of \<3 IU/dl or severe bleeding phenotype
* Receiving low dose FVIII prophylaxis for at least 6 months

Exclusion Criteria:

* Detectable FVIII inhibitor at screening
* Detectable FVIII inhibitor at screening Having other underlying diseases: Juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases

Primary outcomes:
measure: spontaneous and traumatic bleeding rate
timeFrame: 6 months after start low dose emicizumab as secondary prophylaxis treatment
measure: treated spontaneous bleeds, treated joint bleeds
timeFrame: 6 months after start low dose emicizumab as secondary prophylaxis treatment
measure: The function of the knee, elbow, and ankle joints
timeFrame: 6 months after start low dose emicizumab as secondary prophylaxis treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial hospital
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: NUCHANUN KESSAKORN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277055: MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements
Official title: MRI Perfusion Imaging at 3T With TX Parallel RF Technology to Identify Myocardial Ischemia Compared to Invasive FFR Measurements
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perfusion Imaging
MRI
Myocardial Fractional Flow Reserve
Myocardial Ischemia
Lead sponsor: Heart Center Bogenhausen
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with intermediate lesion who underwent cardiac catheterization inluding measurement of the myocardial fractional flow reserve

Brief summary: Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in the western world. It is usually diagnosed by catheterization and coronary arteries are visually assessed by the examiner. Thus having a great spectrum of interobserver differences, especially when it comes to intermediate lesions. The gold standard to assess the haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR). The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR- measurements in patients with intermediate lesions could significantly reduce stent implementation and consequently mortality. However this method is not used in daily routine and is available only in a fraction of catheter labs worldwide. Taking this into account decision finding especially in intermediate lesions remains difficult.

One major step to simplify the invasive approach concerning intermediate lesions would be to establish a non-invasive procedures which localizes the coronary vessel to intervene ahead catheterization.

Do to steady technical development cardiac MRI has become a powerful tool which is able to determine myocardial vitality, perfusion and function. In particular the new generation of 3 Tesla multi transmit MR with its higher field strength and better spatial resolution seems to be able to show first pass myocardial perfusion more precise. With this new technology prefixed to cardiac catheterization clinical relevant information can be made accessible and thus reduce the number of unnecessary implemented stents.


Eligibility criteria: Inclusion Criteria:

* intermediate lesion defined by myocardial fractional flow reserve measurement
* age \> 18 years

Exclusion Criteria:

* pregnancy
* contraindication with adenosin, contrast agents or MR-Scaning
* severe renal dysfunktion
* instable patient(e.g. acute myocardial infarction)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Heart Center Bogenhausen, Munich Municipal Hospital Group
state: Bavaria
Study officials:
References:
Clinical trial NCT01017055: Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
Official title: Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dysphagia
Dysphonia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing revision anterior cervical spine surgery

Brief summary: Evaluate voice and swallowing outcomes post operatively.

Detailed description: Anterior Cervical Decompression and fusion is one of the most common spinal surgical procedures performed in the United States. Common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. The chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. The purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing revision anterior cervical spine surgery

Exclusion Criteria:

* Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.

Primary outcomes:
measure: Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op.
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of life as measured by a self-administered 10 point questionnaire.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William R Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032355: The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section
Official title: The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Carbon Dioxide
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: American Society of Anesthesiologists physical status I and II patients undergoing elective cesarean delivery under combined spinal-epidural (CSE) anesthesia

Brief summary: Maternal hypotension is a common side effect after spinal anesthesia for cesarean delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and blood pooling in blocked areas of the body respectively, are main causes of spinal anaesthesia-induced hypotension during Caesarean delivery.

Cardiac output, which has shown to be a better predictor of organ and placental perfusion than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the maternal population.This is largely because of the lack of availability of accurate and reproducible noninvasive measurement techniques. Up to now, preventing hypotension has continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as markers of cardiovascular status, because these are more easily measured.

Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension during spinal anaesthesia, would also have a positive and significant association.


Eligibility criteria: Inclusion Criteria:

* full-term gestation (\>36 and \<41 weeks of gestation) with a singleton pregnancy

Exclusion Criteria:

* emergency cases
* placenta praevia
* preeclampsia
* cardiovascular or cerebrovascular disease
* morbid obesity with a BMI≥40
* contraindications to spinal anaesthesia

Primary outcomes:
measure: value of PetCO2 and changes in artery pressure
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02077855: Value of Sonographic Diagnosis of Toddler's Fracture of the Tibia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Fractures
Keywords: Sensitivity and Sensitivity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 100
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with suspicion of Toddlers fractures.

Brief summary: This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

Detailed description: This fracture of the distal tibia occurs in 1 to 4 year-old-children. The child usually presents with an acute onset of limp or refusal to bear weight on one leg. Toddlers and young children may present with guarding, but may not have swelling or noticeable deformity.

Radiologic signs can be subtle too. In some cases initial radiographs is negative and fractures are diagnosed on follow-up studies by periosteal reaction.

However, timely diagnosis is important, because it obviates the need for investigations to archive adequate treatment as well as to prevent unnecessary immobilization. The value of sonographic diagnosis of toddler's fracture has been demonstrated. In children it is of particular value as it is comfortable and does not involve the use of ionizing radiation.

The aim of the present study is to investigate the reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.

Eligibility criteria: Inclusion Criteria:

1. Informed consent
2. Suspicion of Toddlers fractures

Exclusion Criteria:

1. Major delay in treatment

Primary outcomes:
measure: Sonographic identification of "Toddler's" fractures
timeFrame: 3y
Secondary outcomes:
measure: US does not cause more discomfort than x-ray
timeFrame: 3y
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UKE Medical School
Study officials:
References: