louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05312346: Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital
Official title: University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Patients on Hemodialysis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These children are attending in our Pediatric dialysis unit at Sohag University Hospital, Egypt between April 2022 and April 2023.

Brief summary: Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO) synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of adherence to treatment .

Anemia is one of the most important complications that affects morbidity and mortality in chronic kidney disease (CKD) patients. It has significant impacts on those patients such as fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and physical activity, growth retardation and decreased cognitive functions, left ventricular hypertrophy, and congestive heart failure So, proper management of anemia is very important .


Eligibility criteria: Inclusion Criteria:

* (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.

Exclusion Criteria:

* Children who have no other co existent hematological disorder .

Primary outcomes:
measure: Hb g/dl
timeFrame: one year
measure: Iron profile
timeFrame: one year
measure: Serum creatinine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Allali S, Brousse V, Sacri AS, Chalumeau M, de Montalembert M. Anemia in children: prevalence, causes, diagnostic work-up, and long-term consequences. Expert Rev Hematol. 2017 Nov;10(11):1023-1028. doi: 10.1080/17474086.2017.1354696. Epub 2017 Oct 12.
citation: Mikhail A, Brown C, Williams JA, Mathrani V, Shrivastava R, Evans J, Isaac H, Bhandari S. Renal association clinical practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol. 2017 Nov 30;18(1):345. doi: 10.1186/s12882-017-0688-1.
citation: Bamgbola OF. Pattern of resistance to erythropoietin-stimulating agents in chronic kidney disease. Kidney Int. 2011 Sep;80(5):464-74. doi: 10.1038/ki.2011.179. Epub 2011 Jun 22.
citation: Akbari A, Clase CM, Acott P, Battistella M, Bello A, Feltmate P, Grill A, Karsanji M, Komenda P, Madore F, Manns BJ, Mahdavi S, Mustafa RA, Smyth A, Welcher ES. Canadian Society of Nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management. Am J Kidney Dis. 2015 Feb;65(2):177-205. doi: 10.1053/j.ajkd.2014.10.013. Epub 2014 Nov 4.
Clinical trial NCT04146246: Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
Official title: Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: G6PD
G6PD Deficiency
Keywords: G6PD
Neonate
Lead sponsor: Baebies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 119
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.

Brief summary: A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.

Detailed description: A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.

Eligibility criteria: Inclusion Criteria:

* Neonates aged \>35 gestational weeks or older.
* Adult subjects who are age 18 and older.
* Adult subjects who weigh at least 110 pounds.
* All ethnicities.
* Male and female subjects.

Exclusion Criteria:

* Adult subjects who weigh less than 110 pounds.
* Subjects with anemia for which an attending physician will not authorize a blood draw.
* Subjects who have received a blood transfusion.
* Subjects who are pregnant.

Primary outcomes:
measure: G6PD enzymatic activity in adults and neonates
timeFrame: Immediately following a blood draw.
Secondary outcomes:
measure: Point of care/near patient results and clinical laboratory results
timeFrame: Immediately following a blood draw.
measure: Arterial/venous whole blood results and tissue capillary test results
timeFrame: Immediately following a blood draw.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Raleigh
country: United States
facility: Wake Med
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center Rainbow Children's Hospital
state: Ohio
Study officials:
affiliation: Director Product Development
name: Rama Sista, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02548546: Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Official title: Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.

Detailed description: Patients with Abdominal Aortic Aneurysm, (AAA), will be identified within the vascular surgery practice. Those patients who meet standard indications for surgery including symptomatic AAA, size \>5.0-5.5 cm, or rapidly enlarging \>0.5 cm per 6 months will have standard pre-operative work-up which includes magnetic resonance angiogram (MRA) and Echocardiogram (ECHO). These pre-operative studies will be modified for the study patients to include electrocardiogram(ECG)-gating (coupled with MR angiogram) and 2-Dimensional speckle-tracking ultrasound of the abdominal aorta. Patients in the study will be followed for 1 year. Measurements will be analyzed for any relationship between aortic wall properties and clinical outcomes such as aneurysm growth, rupture risk or aortic dissection. This study will be comparing 3 groups of patients: no surgery (surveillance), open surgery, and endovascular aneurysm repair (EVAR).

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age with ability to provide informed consent.
* Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter.
* Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason.

Exclusion Criteria:

* Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction.
* Patients who do not require contrast imaging or echocardiogram as part of their care plan.
* Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months.
* Patients unable to tolerate magnetic resonance imaging.

Primary outcomes:
measure: ECHO Imaging
timeFrame: Change from baseline in ECHO imaging measurements
Secondary outcomes:
measure: ECG-gated MRA Imaging
timeFrame: Change from baseline ECG-gated imaging measurements.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Houssam Farres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06530446: SMART PHONE ADDICTION AND ELBOW JOINT PERFORMANCE
Official title: EFFECT OF SMART PHONE ADDICTION ON ELBOW JOINT PREFORMANCE AMONG ADULTS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elbow Joint Performance, Ms Strength, Proprioception and Elbow Functional Abilities
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: both female and male, aged between 18- 30 years old

Brief summary: smart phone addiction negatively impacted the pain in the muscles of the neck, shoulder, elbow, and the hand. the negative impact of prolonged smartphone use has shown an association between smartphone addiction and musculoskeletal pain in different areas of the body. Caution should be taken towards the safe implementation of smartphone use.

The combination of repetitive movements, poor posture, and over-use of mobile phones for texting or playing games, without taking rest breaks, can cause injury to the nerves, muscles, and tendons in the fingers, hands, wrists, arms, elbows, shoulders, and neck, which if ignored, may lead to long-term damage. Staying stationary for hours with the same hand and elbow movements while using mobile phones not only disrupts the posture of the individual but also causes inefficiency at work. Thus, their prolonged use significantly affects the quality of life as well as the activities of daily life of the individual .No previous study has investigated the link between smartphone addiction and elbow joint performance, to the authors' knowledge. Therefore, the primary purpose of this study will be to determine the relationship between smartphone addiction and elbow joint performance.


Eligibility criteria: Inclusion Criteria:

* This study will comprise healthy volunteers between the ages of 18 and 30 who needed to use a smart phone.
* Dominant side will be involved.
* Subjects who put in more than 4 hours per day using smartphone.
* willing to give consent to participate in this study.

Exclusion Criteria:

* recent fracture in neck and upper limb
* any traumatic injury to neck and upper limb prior 6 months
* congenital abnormalities and severe surgical and neurological disorders.
* Pregnant females

Primary outcomes:
measure: MS strength
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03098446: The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Official title: The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Metabolic Syndrome
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be randomly assigned to either the sitting plus exercise or the sitting without exercise group and then, after a one week washout period, complete the other task.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal.

Detailed description: Subjects will undergo three weeks (two intervention, one washout) of testing during which they will participate in two conditions: 1) prolonged sitting (\~14-hours/day) with a 1-hour bout of acute exercise at 65% of pre-intervention VO2max and 2) prolonged sitting (\~14-hours/day) without an acute bout of exercise. During each intervention week, subjects will have 2 days of dietary and activity control, followed by 4 days during which prolonged sitting will occur. On the evening of the 4th day, subjects in the exercise group will perform the acute bout of exercise. On day 5, all subjects will undergo a lipid tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation. Blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* respiratory problems
* musculoskeletal problems that prevent prolonged sitting or exercise
* obesity
* susceptibility to fainting

Primary outcomes:
measure: Plasma Triglycerides
timeFrame: 6-hours
Secondary outcomes:
measure: Plasma Insulin
timeFrame: 6-hours
measure: Plasma Glucose
timeFrame: 6-hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Human Performance Laboratory
state: Texas
Study officials:
References:
Clinical trial NCT00810446: Safety And Efficacy Of Rifabutin In HIV Patients
Official title: DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MYCOBUTIN (REGULATORY POST MARKETING COMMITMENT PLAN).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-tuberculous Mycobacterial Diseases
Tuberculosis
Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0061007 prescribes the Mycobutin®.

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Mycobutin®.

Primary outcomes:
measure: Number of Patients With Adverse Drug Reactions in This Surveillance
timeFrame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
measure: The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
timeFrame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
measure: Number of Participants With Adverse Drug Reactions by Gender
timeFrame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
measure: Number of Participants With Adverse Drug Reactions by Age
timeFrame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
measure: Number of Participants With Adverse Drug Reactions by Diagnosis
timeFrame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
measure: Clinical Response Rate (Therapeutic)
timeFrame: 6.5 years (at maximum)
measure: Clinical Response Rate (Therapeutic) by Gender
timeFrame: 6.5 years (at maximum)
measure: Clinical Response Rate (Therapeutic) by Age
timeFrame: 6.5 years (at maximum)
measure: Clinical Response Rate (Therapeutic) by Diagnosis
timeFrame: 6.5 years (at maximum)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00972946: Cell Tracking Using Superparamagnetic Particles of Iron Oxide (SPIO) and Magnetic Resonance Imaging (MRI) - A Pilot Study
Official title: The Use of Magnetic Resonance Imaging and Superparamagnetic Particles of Iron Oxide in Cardiovascular Disease - a Pilot Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: MRI
SPIO
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons of Edinburgh
name: Translational Medicine Research Collaboration
First posted: 2009-09-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The ability to label specific cells and image their natural movements in vivo would allow researchers to investigate the mechanisms of disease progression. In addition, cell-based therapy, especially stem cell therapy, requires non-invasive monitoring of transplanted cells to follow their bio-distribution and biological function. Because of recent interest in stem cell treatment, several methods have been investigated for in vivo cell tracking. The investigators propose to assess whether the magnetic resonance imaging (MRI) contrast agent Endorem (superparamagnetic particles of iron oxide) can be used to label cells for in vivo tracking using MRI. The investigators will use 20 healthy human volunteers to:

1. Assess the feasibility of imaging Endorem-labelled cells in vivo
2. Compare the distribution of Endorem-labelled cells with that of intravenous injection of Endorem


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age \>18 years

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI scanning (detected by safety questionnaire) including severe claustrophobia
* Inability or refusal to give informed consent
* Renal or hepatic dysfunction
* HIV/hepatitis B/ hepatitis C/ HTLV/ syphilis
* Intercurrent illness
* Blood dyscrasias

Primary outcomes:
measure: Change in signal intensity in the region of interest on MRI scanning
timeFrame: 0 hours, 24 hours, 48 hours, 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh/Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: David E Newby
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richards JM, Shaw CA, Lang NN, Williams MC, Semple SI, MacGillivray TJ, Gray C, Crawford JH, Alam SR, Atkinson AP, Forrest EK, Bienek C, Mills NL, Burdess A, Dhaliwal K, Simpson AJ, Wallace WA, Hill AT, Roddie PH, McKillop G, Connolly TA, Feuerstein GZ, Barclay GR, Turner ML, Newby DE. In vivo mononuclear cell tracking using superparamagnetic particles of iron oxide: feasibility and safety in humans. Circ Cardiovasc Imaging. 2012 Jul;5(4):509-17. doi: 10.1161/CIRCIMAGING.112.972596. Epub 2012 Jul 10.
Clinical trial NCT05108246: Home-Based Dual-Task Training for Older Adults
Official title: Home-Based Dual-Task Training to Improve Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-11-04
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.


Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Male or female
* Screened positive for mild cognitive impairment (Montreal Cognitive Assessment score 23 to 26 points
* Having no absolute contraindications to non-physician supervised exercise.

Exclusion Criteria:

* Lower-body amputation
* Non-English language speaker

Primary outcomes:
measure: Change in Balance: Left Limb
timeFrame: Pre-test (time 0) and End point (12 weeks)
measure: Change in Balance: Right Limb.
timeFrame: Pre-test (time 0) and End point (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, SUNY
state: New York
Study officials:
References: