louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01278069: PET-CT in AML for Detection of Extramedullary AML Manifestations
Official title: PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newly Diagnosed or Relapsed Acute Myeloid Leukemia
Keywords: Acute myeloid Leukemia
Myeloid Sarcoma
Extramedullary Acute myeloid Leukemia
18FDG-PET-CT
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 93
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: PROBABILITY_SAMPLE
Study population: Inpatients or Outpatients with newly diagnosed or relapsed AML AML

Brief summary: Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with AML with this finding. Information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in AML so far. This observational trial will include adult patients with newly diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed or relapsed AML
* AML FAB M0-2, M4-7
* Signed informed consent after patient information
* Male and female patients with AML age 18-80
* 18FDG-PET-CT is available within a period of 5 days after diagnosis of AML

Exclusion Criteria:

* AML FAB M3 (Promyelocytic Leukemia)
* lacking willingness to cooperate
* pregnancy or insufficient contraception
* 18FDG-PET-CT is not available within a period of 5 days after diagnosis of AML
* Medical condition of the patients requires an immediated start of chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
state: Saxony
Study officials:
References:
citation: Stolzel F, Rollig C, Radke J, Mohr B, Platzbecker U, Bornhauser M, Paulus T, Ehninger G, Zophel K, Schaich M. (1)(8)F-FDG-PET/CT for detection of extramedullary acute myeloid leukemia. Haematologica. 2011 Oct;96(10):1552-6. doi: 10.3324/haematol.2011.045047. Epub 2011 Jun 17.
Clinical trial NCT05575869: Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
Official title: Evaluate the Impact of Online Educational Material (PRONEtect Educational Hub) on Nursing Students' Knowledge, Confidence Levels, and Application of Knowledge Regarding Skin Protection of the Prone Ventilated Patient - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Position
Pressure Ulcer
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students.

Participants will be asked to complete a baseline self-efficacy evaluation and a baseline knowledge test which were validated by the 11-member international expert panel previously established.

After randomization, the control group will be asked to attend a classic 1-hour lecture at the nursing school about the topic of prone positioning and skin/tissue damage prevention.

The experimental group will get access to the PRONEtect educational website containing short simulation videos and other learning materials.

Three weeks later the participants will be asked to complete the self-efficacy evaluation and knowledge assessment again, additionally a knowledge application assessment.

All the questionnaires will be administered via Qualtrics.


Eligibility criteria: Inclusion Criteria:

* Final year nursing students studying towards their Bachelor in Nursing degree
* Chosen topics of critical care nursing as supplementary subject or critical care subjects as part of their course or complex wound management as part of their course.

Exclusion Criteria:

Nursing students who are not yet in their final year of studies.

Primary outcomes:
measure: Knowledge assessment (test score)
timeFrame: 3 weeks
Secondary outcomes:
measure: Confidence levels (survey scores)
timeFrame: 3 weeks
measure: Difference between the "Knowledge application" (test score) between the groups
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
References:
Clinical trial NCT03222869: Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Official title: Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngotracheal Stenosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 3
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: Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.

Brief summary: This research is being done to determine the resistance across stenosis in the airway.

Detailed description: There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.

Exclusion Criteria:

* Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)
* Patients that are not cleared for surgery by the preoperative evaluation
* Patients with severe laryngotracheal stenosis
* Patients who are morbidly obese (BMI \> 40)
* Patients with lung disease (asthma, COPD)

Primary outcomes:
measure: Pressure (cm H20)
timeFrame: Up to One Year
Secondary outcomes:
measure: Flow Rate (L/min)
timeFrame: Up to One Year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alexander Hillel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04396769: Family Lifestyle Overweight Prevention Program-Physical Activity Only
Official title: Family Lifestyle Overweight Prevention Program-Physical Activity Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2020-05-21
Enrollment: 491
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized control trial evaluates the physical activity component of the Family Lifestyle Overweight Prevention Program compared to physical education class as usual among Hispanic middle school students.

Detailed description: Family Lifestyle Overweight Prevention Program (FLOW) is an intensive, multi-component obesity intervention designed to take place during physical education class. This intervention has established efficacy at improving standardized BMI among low income, Hispanic middle school students with overweight classification or obesity. However, the efficacy of individual components of the intervention have not been investigated. The purpose of this study was to compare only the physical activity component of FLOW to a physical education class as usual. The primary outcome of the study is time spent in moderate-vigorous physical activity. Secondarily the study evaluated the impact of the intervention on standardized BMI.

Eligibility criteria: Inclusion Criteria:

* age 10-17 years old
* enrolled in a middle school PE class at YES Prep Brays Oaks

Exclusion Criteria:

* pregnant
* cognitive impairment significantly below average age or grade level

Primary outcomes:
measure: Weekday moderate-vigorous physical activity (MVPA)
timeFrame: six months
Secondary outcomes:
measure: Weekend moderate-vigorous physical activity (MVPA)
timeFrame: six months
measure: standardized BMI (zBMI)
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Craig A Johnston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02938169: The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Official title: The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
exercise
electromyography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.

Detailed description: * Design: Prospective study
* Setting: hospital rehabilitation department
* Intervention: Participants are randomly assigned 4 different exercise group: flexibility exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking exercise group and bracing+ walking + stabilization exercise group
* Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque of lumbar extensor by surface electromyography Time duration of capability of maintenance the posture

Eligibility criteria: * Inclusion Criteria:

  * Age\>20
  * Who suffered low back pain more than 3 months.
* Exclusion Criteria:

  * Pregnancy
  * Under 20-year-old
  * Who have significant neurologic deficit
  * Who experienced spine operation
  * Who cannot walking

Primary outcomes:
measure: Low Back Pain at Resting Status
timeFrame: Baseline Pre-Exercise and 6 weeks
measure: Disability for Low Back Pain
timeFrame: Baseline Pre-Exercise and 6 weeks
measure: Visual Analog Scale of Low Back Pain During Rest
timeFrame: 0 week to 6weeks
Secondary outcomes:
measure: Muscle Strength(Endurance)
timeFrame: Baseline Pre-Exercise and 6 weeks
measure: Depression Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungji-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Juseok Ryu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lee HI, Lee ST, Kim M, Ryu JS. Sex differences in predicting chronicity of low-back pain after acute trauma using lumbar muscle area. Am J Phys Med Rehabil. 2015 Feb;94(2):123-30. doi: 10.1097/PHM.0000000000000149.
Clinical trial NCT02471469: Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
Official title: Personalizing Enzalutamide Therapy by Understanding the Relation Between the Decrease in the Expression Profile of a Panel of Preselected microRNAs, Tumor Related mRNAs and Treatment Response in Chemotherapy Naive Patients With mCRPC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Resistant Prostate Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2015-06-15
Enrollment: 40
Sex: MALE
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: chemotherapy naive patients with metastatic CRPC

Brief summary: The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy.

Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.


Eligibility criteria: Inclusion Criteria:

* Male patients with chemotherapy naive metastatic castration resistant prostate cancer\*
* Age at least 18 years
* Patients from who it is possible to collect blood samples
* Patient who are able and willing to give written informed consent prior to screening and enrollment
* Life expectancy of \> 6 months
* Measurable disease \*definition of CRPC according to EAU guidelines 2014

Exclusion Criteria:

* None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study

Primary outcomes:
measure: Relation between biomarker response and therapeutic response
timeFrame: 6 months
Secondary outcomes:
measure: Relation between drug exposure, biomarker and therapeutic response
timeFrame: 6 months
Other outcomes:
Locations:
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
Study officials:
affiliation: Radboud University Medical Center
name: Nielka van Erp, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benoist GE, van Oort IM, Boerrigter E, Verhaegh GW, van Hooij O, Groen L, Smit F, de Mol P, Hamberg P, Dezentje VO, Mehra N, Gerritsen W, Somford DM, van Erp NPH, Schalken JA. Prognostic Value of Novel Liquid Biomarkers in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide: A Prospective Observational Study. Clin Chem. 2020 Jun 1;66(6):842-851. doi: 10.1093/clinchem/hvaa095.
Clinical trial NCT01211769: Effects of Omegas 3 and 6 on Alcohol Dependence
Official title: Alcohol Dependence: Study of the Possible Reduction of Compulsion by Association of Naltrexone With Poly-unsaturated Fatty Acids (PUFAs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: PUFAs
Alcoholism
Treatment
Effectiveness
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Associacao Fundo de Incentivo a Psicofarmcologia
First posted: 2010-09-29
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.


Eligibility criteria: Inclusion Criteria:

* severe alcohol dependence
* no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range

Exclusion Criteria:

* history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies
* dependences other than alcohol and/or tobacco
* psychiatric disorders
* test laboratories results outside the reference range

Primary outcomes:
measure: "Drinking Days" in the Previous Month
timeFrame: 3 months
Secondary outcomes:
measure: Short Alcohol Dependence Data Questionnaire (SADD)
timeFrame: 3 months
measure: Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: José Carlos F Galduróz, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogaca MN, Santos-Galduroz RF, Eserian JK, Galduroz JC. The effects of polyunsaturated fatty acids in alcohol dependence treatment--a double-blind, placebo-controlled pilot study. BMC Clin Pharmacol. 2011 Jul 26;11:10. doi: 10.1186/1472-6904-11-10.
Clinical trial NCT06086769: High Flow Oxygen Therapy Effect on Healthy Subjects
Official title: Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Diaphragm
Respiratory Rate
Keywords: High flow nasal canula
High flow nasal canula therapy
Diaphragm thickening fraction
Work of breathing
Respiratory rate
Lead sponsor: Argentinian Intensive Care Society
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The use of high-flow nasal cannula (HFNC) has increased. Diaphragmatic ultrasonography is a tool that, as a noninvasive complement to esophageal pressure (Pes) measurement, allows the evaluation of diaphragm function and reflects, through the diaphragm thickening fraction (DTf), the magnitude of diaphragmatic fiber recruitment. The objective of this study was to evaluate the impact of HFNC therapy on the DTf in healthy subjects. Second, this study aimed to assess the behavior of the respiratory rate (RR) and the work of breathing in these subjects.


Eligibility criteria: Inclusion Criteria:

* healthy subjects over 18 years old

Exclusion Criteria:

* contraindication for esophageal balloon placement
* diagnosis of lung disease
* smokers

Primary outcomes:
measure: Diaphragm thickening fraction.
timeFrame: Immediately after 5 min of each condition (baseline, 20 and 40 liters per minute) the diaphragmatic thickness was measured at the end of inspiration y de la expiration during 3 consecutive respiratory cycles (each cycle is between 3 and 10 seconds)
Secondary outcomes:
measure: Respiratory Rate
timeFrame: The number of breaths per minute was recorded in 60 seconds.
measure: Esophageal pressure swing (Pes).
timeFrame: 5 minutes each condition
measure: Esophageal pressure-time product per minute (PTPes/min).
timeFrame: Through study completion, an average of 24 weeks
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Británico de Buenos Aires
name: Gustavo A Plotnikow, RT
role: STUDY_CHAIR
References:
Clinical trial NCT03835169: Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France
Official title: Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France: A Nationwide Retrospective Observational Cohort Study Using Data From the French Hospital Discharge Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Acute Coronary Syndrome
Acute Cardiac Failure
Heart Rhythm Disorders
Valve Pathologies
Keywords: Cardiac intensive care unit
Organization
Prognostic score
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 200000
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: Patients admitted (at least one time) in a french CICU in 2017

Brief summary: Retrospective, observational cohort study.

Objectives:

To identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (CICU). The clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french CICU.

To identify the length of stay key determiners of patients admitted in french CICU.

The study will use data from one of the french nationwide healthcare systems database (SNDS) : the national hospital discharge database (PMSI) to be precise.


Eligibility criteria: Inclusion criteria:

* Being admitted at least one time in a french CICU in 2017
* Being covered by the mandatory french national health insurance plan in 2017 without discontinuity

Exclusion criteria:

* Being older than 18 years of age

Primary outcomes:
measure: Mortality rate
timeFrame: 1 day
Secondary outcomes:
measure: Length of stay at a CICU
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: François Roubille, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: