louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06859827: Role of CMR-FT in Assessment of HCM and Athlete's Heart.
Official title: The Role of Cardiac MRI Feature Tracking in Assessment of Hypertrophic Cardiomyopathy and Athlete's Heart.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Cardiomyopathies
Athlete Heart
Keywords: Cardiac MRI feature tracking
Hypertrophic cardiomyopathy
Athlete's heart
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any age between 20 and 50 years either male or female with minor complains and suspected by Echo to be hypertrophic cardiomyopathy, athlete's exhibiting no symptoms.

Brief summary: Using cardiac MRI feature tracking to asses myocardial motion differences in athlete's heart and discovered hypertrophic cardiomyopathy patients to increase diagnostic accuracy of hypertrophic cardiomyopathy.

Detailed description: Cardiac MRI is the gold standard for assessing cardiac function without significant limitations of anatomical restrictions. CMR-FT helps in assessment of myocardial deformation on routinely obtained by steady state free precision (SSFP) cine images. CMR-FT is used in cardiac research and became common in clinical practice. It has been used in assessment of wide spectrum of cardiac diseases and provides for comprehensive and reliable assessments of heart function.

Eligibility criteria: Inclusion Criteria:

* Patients suspected to be hypertrophic cardiomyopathy by echocardiography..
* Athletes and heavy workers,, healthy volunteers also included.

Exclusion Criteria:

* Patients with absolute or relative contraindications to magnetic resonance imaging (e.g intra-ocular metallic foreign body, claustrophobia, etc) or contra-indication to MRI contrast medium.
* Clinical morbidities with absolute contraindication to anesthesia during the examination in un-cooperative patients where sedation is required.

Primary outcomes:
measure: Use of cardiac MRI feature tracking in detection of myocardial deformation abnormalities and diagnostic confirmation and detection of hypertrophic cardiomyopathy.
timeFrame: 6months to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospital
Study officials:
References:
Clinical trial NCT06250127: The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion
Official title: The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaw Protrusions
Keywords: Orthopedic appliance
Maxillary protraction
Petit facemask
Cl III malocclusion
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients

Detailed description: It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.

Eligibility criteria: Inclusion Criteria:

1. Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet \< 0 mm.
2. Concave profile with normal lower facial height (clinically and radiographically).
3. Good oral health free from caries and periodontal problems at the start of treatment.

Exclusion Criteria:

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with vertical growth pattern or backward mandibular rotation tendency.
3. Patients with gross facial asymmetry.
4. Patients with cleft lip and palate and/or craniofacial syndrome
5. Patients with bad oral habit.
6. Active periodontal disease.
7. Previous history of TMJ signs or symptoms

Primary outcomes:
measure: Dentoskeletal and soft tissue changes
timeFrame: (T0) before starting the treatment and (T1) after 9 months of treatments.
Secondary outcomes:
measure: Skeletal and soft tissue changes
timeFrame: (T0) before starting the treatment and (T1) after 9 months of treatments.
measure: Dental changes
timeFrame: (T0) before starting any treatment and (T1) after 9 months of treatments
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry-University of Baghdad
state: Al-Rusafa
city: Baghdad
country: Iraq
facility: Mushriq Abid
Study officials:
References:
Clinical trial NCT01135927: A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)

Primary outcomes:
measure: Area under the NN1250 GIR (glucose infusion rate) curve
timeFrame: During one dosing interval at steady state
Secondary outcomes:
measure: Area under the serum insulin detemir concentration-time curve
timeFrame: During one dosing interval at steady state
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ikushima I, Kaku K, Hirao K, Bardtrum L, Haahr H. Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients. J Diabetes Investig. 2016 Mar;7(2):270-5. doi: 10.1111/jdi.12399. Epub 2015 Aug 27.
Clinical trial NCT04215627: Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients
Official title: Comparison Between Invasive Hemodynamic Monitoring, Using the PiCCO Monitor, to a Non-invasive Photoplethysmography Based Device in Hemodynamic Unstable Critically Ill Patients, With Vasopressor Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Hemodynamic Instability
Keywords: Critically Ill patients
blood pressure
vital signs
non-invasive monitoring
Vasopressor support
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Assaf-Harofeh Medical Center
First posted: 2020-01-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICU unit, suffering from shock and in need for vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours, and that the treating physician has decided there is a need to insert a PiCCO catheter for invasive monitoring of their hemodynamic condition. Total period of monitoring will be up to 72 hours.

Brief summary: The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.


Eligibility criteria: Inclusion Criteria:

* ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours
* Patients in which PiCCO monitoring is needed

Exclusion Criteria:

* Refusal of the subject
* Technical difficulties in insertion of the PiCCO catheters
* Significant cardiac arrhythmias
* Significant valvular disease
* Pregnancy

Primary outcomes:
measure: Level of accordance between the BB-613PW to the PiCCO
timeFrame: 72 hours per individual
Secondary outcomes:
Other outcomes:
Locations:
city: Rishon LeZion
country: Israel
facility: The Assaf Harofeh Medical Center, Zrifin
Study officials:
affiliation: The Assaf Harofeh Medical Center, Tzrifin, Israel
name: Ayana Dvir, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726427: A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
pharmacodynamics
AZD1656
safety
tolerability
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
* History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator

Primary outcomes:
measure: Safety variables (AE's, BP, pulse, lab variables, and ECG)
timeFrame: Safety variables taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca CPU, Philadelphia, PA
name: Sylvan Hurewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.
Clinical trial NCT02487927: The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning
Official title: The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Medicine
Mechanical Ventilation
Weaning
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mechanical vetilation patients in ICU, and the patients are weaninng candidates

Brief summary: To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.

Detailed description: 108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.

Eligibility criteria: Inclusion Criteria:

* mechanical ventilation patients
* prepared to weaning
* sign on the acknowledged

Exclusion Criteria:

* endotracheotomy
* single lung
* pregnant
* heart,liver,renal failure

Primary outcomes:
measure: the reasons of difficult weaning
timeFrame: 30 mins
Secondary outcomes:
measure: The predictive value of diaphragm associated values in weaning
timeFrame: 30mins
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Haibo Qiu, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06488027: DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS
Official title: DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Insomnia Disorder
Lead sponsor: AB Biotek
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with insomnia symptoms attending AdSalutem sleep center

Brief summary: Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* With one or more symptoms of insomnia
* Explicit acceptance to participate to the study through informed consent

Exclusion Criteria:

* Insomnia symptoms that could be justified by the existance of another sleep pathology (e.g., narcolepsy)

Primary outcomes:
measure: number of patients with insomnia symptoms and DAO deficiency
timeFrame: at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: AdSalutem Sleep Institute
Study officials:
affiliation: AdSalutem Sleep Institute
name: Julia Ferrer Garcia, MSc
role: STUDY_CHAIR
References:
citation: Schnedl WJ, Lackner S, Enko D, Schenk M, Holasek SJ, Mangge H. Evaluation of symptoms and symptom combinations in histamine intolerance. Intest Res. 2019 Jul;17(3):427-433. doi: 10.5217/ir.2018.00152. Epub 2019 Mar 7.
citation: Garcia-Martin E, Ayuso P, Martinez C, Agundez JA. Improved analytical sensitivity reveals the occurrence of gender-related variability in diamine oxidase enzyme activity in healthy individuals. Clin Biochem. 2007 Nov;40(16-17):1339-41. doi: 10.1016/j.clinbiochem.2007.07.019. Epub 2007 Aug 11.
citation: Ayuso P, Garcia-Martin E, Martinez C, Agundez JA. Genetic variability of human diamine oxidase: occurrence of three nonsynonymous polymorphisms and study of their effect on serum enzyme activity. Pharmacogenet Genomics. 2007 Sep;17(9):687-93. doi: 10.1097/FPC.0b013e328012b8e4.
Clinical trial NCT01432327: The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
Official title: The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: motor activity
randomized controlled trial
feedback
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to assess an increase of daily physical activity from electronic self-monitoring, to compare these values to the 10.000 step program, and to compare with real-time feedback with and without guidance from a Personal Coach.

Detailed description: The purpose of this intervention study is to determine the effectiveness of continuous self-monitoring and real-time feedback from the SenseWear Armband (BodyMedia) alone and in combination with Personal Coaching to enhance physical activity and influence consciousness about its own physical activity patterns over a 12-month period in sedentary Flemish employees. The investigators hypothesize that the use of the feedback will increase awareness and subsequent physical activity levels of inactive office workers. Another hypothesizes is that the weekly meeting with a Personal Coach will add a controlling element and therefore employees of the 'coaching group' will have a higher physical activity level at the end of the intervention period compared to the other groups.

Eligibility criteria: Inclusion Criteria:

* Employee
* Physical Activity Level \< 1.71 MET
* Willing to wear the SenseWear Armband for 5-6 weeks

Exclusion Criteria:

* Student
* Senior

Primary outcomes:
measure: Physical Activity Level
timeFrame: One year
Secondary outcomes:
measure: Daily Energy Expenditure in Physical Activity
timeFrame: One year
measure: Percent of Participants Losing Fat Percentage
timeFrame: One Year
measure: Stages of Motivational Readiness for Physical Activity
timeFrame: One Year
measure: Step Count
timeFrame: One Year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven - Tervuursevest 101
Study officials:
affiliation: KU Leuven
name: Johan Lefevre, Prof Dr.
role: STUDY_DIRECTOR
References:
citation: Van Hoye K, Wijtzes AI, Lefevre J, De Baere S, Boen F. Year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity. BMC Public Health. 2018 Apr 12;18(1):492. doi: 10.1186/s12889-018-5402-0.
Clinical trial NCT06504927: Biomarker Discovery in Lung Cancer - Malaysia
Official title: Biomarker Discovery in Lung Cancer - Malaysia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: MiRXES Pte Ltd
First posted: 2024-07-17
Enrollment: 400
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort A Subjects in this cohort are recruited if they have either of the following: pre-existing chronic obstructive pulmonary disease (COPD) or are found to have lung nodules smaller than 11mm, or nodules that are deemed not for biopsy by the attending physician.

Cohort B Subjects in this cohort are highly suspicious of having lung cancer. From the results of the X-ray or LDCT imaging, the subject would have nodules larger than 11mm, or show signs of lung cancer.

Brief summary: This study aims to

1. Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.
2. Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

Detailed description: With existing evidence showing the utility of using liquid biopsy for early cancer detection, the investigators hypothesized that cell-free DNA and/or RNA expression changes during disease progression, and biomarker signature can be derived from the changes in expression levels. The investigators aim to discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 30 and above.
* No previous history of any cancers.
* Able to provide X-ray and/or LDCT results.
* Have either COPD or pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician
* Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care.
* Willing to provide up to 30mL of blood in month-0 (first visit) and up to 21mL in the next standard of care follow up visit (second visit).

Exclusion Criteria:

* Subject has received chemotherapy or radiotherapy for cancer treatment, and any other cancer-related treatment.
* Subject is pregnant or lactating (self-declaration).
* Subject is unwilling or unable to provide signed informed consent

Primary outcomes:
measure: To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: Mau Ern Poh
role: PRINCIPAL_INVESTIGATOR
References: