louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03228004: Type 1 Diabetes Data Acquisition and Transfer Adherence Study
Official title: Type 1 Diabetes Data Acquisition and Transfer Adherence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.


Eligibility criteria: Inclusion Criteria:

* Diagnosis with T1D at least 6 months before consent is obtained
* Aged ≥ 2 years and ≤17 years at time of enrollment
* Must have access to a smartphone, tablet or computer at home with wireless connectivity
* Last HbA1c of ≥7.6% and ≤11%
* Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
* Ability to read and speak English
* Patient at UF Health Pediatric Diabetes Clinic

Exclusion Criteria:

* Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
* Inability to read and speak English
* Not using insulin therapy
* Lack of access to mobile device or computer with wireless internet connectivity
* Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload

Primary outcomes:
measure: Improved glycemic control
timeFrame: 16 weeks
measure: Frequency of data upload
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Anastasia Albanese-O'Neill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05414604: Calculating the Volume of the Paravertebral Space
Official title: Calculating the Volume of the Paravertebral Space With 3D Computerized Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Disc Degenerative Disease
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had a spine CT scan in our hospital due to vertebral disc degenerative disease

Brief summary: Volume of the paravertebral spaces of the tharic and lumbar regions will be measured.

Detailed description: Paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. In addition, paravertebral block is a volume dependent technique. However, there are few cadaveric studies that investigates the volume of the paravertebral space.

This study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3D computerized scan in Kocaeli University Hospital.

Eligibility criteria: Inclusion Criteria:

* Patients who had a CT scan of the spine in our hospital

Exclusion Criteria:

* Patients with scoliosis or known vertebral abnormalities

Primary outcomes:
measure: Lumbar paravertebral space
timeFrame: Baseline
measure: Thoracic paravertebral space
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
References:
Clinical trial NCT00374504: Prediction of Postoperative Pain by an Electrical Pain Stimulus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM.

Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. The standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. Morphine was used for break-through pain.

Before cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. After cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score.

Data was analyzed using AUC and non-parametric test, P \< 0,05.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women scheduled for elective cesarean section

Exclusion Criteria:

* ASA III -IV
* Chronic pain conditions.
* Pacemaker.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rrigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Per Rotbøll Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen PR, Norgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6. doi: 10.1111/j.1399-6576.2007.01271.x.
Clinical trial NCT04265404: Evaluation of qSOFA in Neurosurgical Patients
Official title: Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Brain Trauma
Subarachnoid Hemorrhage
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients brought to the ICU with Inclusion Citeria.

Brief summary: The aim of the study is to look if Quick Sequential Organ Failure Assessment Score score in detecting a eary Sepsis is afflicted by neurosurgical disorders


Eligibility criteria: Inclusion Criteria: one of the following diseases

* Subarachnoidal Bleeding
* Traumatic brain injury
* Spondylodiszitis

Exclusion Criteria:

* intubated before income
* Age under 16

Primary outcomes:
measure: Baseline measurement of qSOFA at admission to ICU
timeFrame: Measurement at the time of admission to the intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universität
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe Universität
name: Jürgen Konczalla, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875704: Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy
Official title: Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stargardt Disease
Diabetic Retinopathy
Macular Degeneration (Age Related)
Keywords: DR
AMD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stargardt disease, AMD, DR patients and controls

Brief summary: In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.

Detailed description: People with Stargardt disease, age related macular degeneration (AMD) and diabetic retinopathy (DR) have decrease in central vision from damage to photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers that can be measured in eye fluid (aqueous humor). In this study, these biomarkers will be assessed in people with Stargardt disease, age related macular degeneration and diabetic retinopathy, compared to controls.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age at least 18 years
* For the study group, patients diagnosed with Stargardt disease, age related macular degeneration and diabetic retinopathy by the investigators, based on clinical phenotype
* For the control group, patients with no retinal disease undergoing cataract surgery will be eligible.

Exclusion Criteria:

• None

Primary outcomes:
measure: Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06500104: The Effects of Kefir on Pediatric Obesity
Official title: The Effects of Kefir on Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kefir, a traditional fermented dairy product in the North Caucasus region, is produced through the fermentation of milk by lactic acid bacteria and yeast. In murine studies, it has been observed that consumption of kefir by obese mice resulted in significantly reduced body weight compared to non-kefir-consuming obese mice. Furthermore, insulin resistance and fatty liver conditions showed improvement in the kefir-fed obese mice. Kefir was found to have its effects on obesity-related conditions through the inhibition of lipid synthesis, stimulation of fatty acid oxidation, elevation of basal metabolic rate, and modulation of oxidative damage.

Obesity has emerged as a global epidemic, and its prevalence in pediatric population is rapidly increasing. Obesity is defined as having a body mass index (BMI) above the 95th percentile for the age. According to statistics from the Health Promotion Administration in Taiwan, the prevalence of obesity among elementary and junior high school students in 2021 was 27.1% and 31.2%, respectively. This implies that approximately one out of every three to four students is obese. Insulin resistance and fatty liver are two common manifestations of childhood obesity. Insulin resistance is found closely linked to type 2 diabetes. Prolonged and chronic fatty liver can progress to cirrhosis and even hepatocellular carcinoma. Effective management of obesity holds the occurrence of these diseases. The objective of this study is to analyze the potential benefits of incorporating kefir into the diet of obese children regarding the improvement of obesity-related outcomes.


Eligibility criteria: Inclusion Criteria:

* body weight above 50 kilograms, body mass index (BMI)-for-age above the 95th percentile

Exclusion Criteria:

* diabetes mellitus, liver diseases other than non-alcoholic fatty liver disease, cardiovascular diseases other than hypertension and dyslipidemia, renal diseases, neurologic diseases, growth hormone deficiency, thyroid diseases, adrenal disorders, any use of medication for more than 6 months before or during this study, and any adverse responses to dairy products.

Primary outcomes:
measure: BMI
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Children's Hospital
Study officials:
References:
Clinical trial NCT04537104: Remote Monitoring in Patients With Heart Failure
Official title: Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: arrhythmias
heart failure
remote monitoring
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Coala Life, Inc
First posted: 2020-09-03
Enrollment: 130
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: Newly diagnosed heart failure patients \> 18 years of age from heart failure clinic

Brief summary: This study is a prospective cohort study with consecutive enrollment of newly diagnosed heart failure patients, investigating the prevalence and types of arrhythmias in this high-risk population using non-invasive remote monitoring with the Coala Heart Monitor. Participants are scheduled to use the Coala Heart Monitor twice daily or during symptoms (e.g. syncope, presyncope, palpitations, chest discomfort, or shortness of breath) to record a thumb and chest ECG over 3 months. Patient compliance with the recordings, self-reported health, response to technology, and experience using the device will additionally be assessed by self-developed questionnaires and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months.


Eligibility criteria: Inclusion Criteria:

* Owns or has access to a smartphone
* Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)

Exclusion Criteria:

* Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment
* Pacemaker
* Cardiac resynchronization device
* Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.
* Expected survival ≤ 6 months
* Absolute contraindications for starting OAC treatment

Primary outcomes:
measure: New-onset arrhythmias
timeFrame: 3 months
Secondary outcomes:
measure: Patient compliance
timeFrame: Week 8
measure: Patient self-reported health
timeFrame: 3 months
measure: Patient-reported outcomes
timeFrame: 3 months
measure: Assessing recordings
timeFrame: 3 months
measure: Subsequent prescriptions
timeFrame: 3 years
measure: Subsequent implantations
timeFrame: 3 years
measure: Subsequent readmissions
timeFrame: 3 years
measure: All-cause mortality
timeFrame: 3 years
measure: Cardiovascular mortality
timeFrame: 3 years
measure: Admissions for worsening heart failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Herlev & Gentofte Hospital
state: Hellerup
Study officials:
References:
Clinical trial NCT04819204: Testosterone and Neurovascular Control in Humans
Official title: Exploring the Role of Testosterone on Neurovascular Control in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.

Detailed description: Sex hormones play a pivotal role in neurovascular function in humans. In recent years, great strides have been made in elucidating the roles of estrogen and progesterone on autonomic and vascular control in women; however, very little is known about the impact of testosterone in men. Given that low testosterone levels are associated with an increased risk of cardiovascular disease, reduced exercise capacity and vascular dysfunction, it is evident that testosterone plays a pivotal role in autonomic and vascular function in men. Our current understanding of testosterone's effects on neurovascular control are confounded by numerous factors that independently alter autonomic and vascular function such as aging and chronic disease (e.g. cardiovascular disease, metabolic disease). The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in young men to better isolate the effects of testosterone from the aforementioned confounding factors. The outcomes of these studies will provide novel information regarding the role of male sex hormones in autonomic and vascular control, and further our understanding of the influence of sex hormones on human physiology.

Eligibility criteria: Inclusion Criteria:

* Moderately active
* Free of chronic disease

Exclusion Criteria:

* congenital or acquired hypogonadism
* drug/alcohol dependence
* hypertension
* current smoker
* current opioid or cannabis user
* diabetes
* inability to provide written consent
* parkinson's disease
* cardiovascular disease
* testosterone use within the last year

Primary outcomes:
measure: Muscle sympathetic nerve activity
timeFrame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
measure: Endothelial function
timeFrame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
measure: Forearm blood flow
timeFrame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Secondary outcomes:
measure: Skeletal muscle microvascular blood flow
timeFrame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Other outcomes:
measure: Sex hormones
timeFrame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Locations:
city: London
country: Canada
facility: the University of Western Ontario
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Joel K Shoemaker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530304: Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
Official title: Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Arch
Aortic Arch Aneurysm
Dissection of Aortic Arch
Triple Branch
Keywords: Aortic arch pathologies
Aortic arch aneruysm
Aortic arch dissection
triple branch
stentgraft
Double branch
Inner branch
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from patients presenting to participating hospitals with aortic pathology and meeting inclusion and exclusion criteria.

Brief summary: Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Presence of Aortic arch pathology
* Treatment planned with triple inner branch from Terumo Aortic
* Availability of the patients during the follow up period
* Informing patients about the study and providing written informed consent

Exclusion Criteria:

* Women of childbearing age
* Patients under 18 years

Primary outcomes:
measure: Mortality
timeFrame: 30 days after intervention
measure: feasibility in terms of cannulation and stentgrafting of the three branches
timeFrame: During intervention
measure: Stroke
timeFrame: 30 days after intervention
Secondary outcomes:
measure: Morbidity
timeFrame: during the follow up period of 3 year
measure: Endoleaks Type I and III
timeFrame: during intervention and the follow up period of 3 year
measure: Longterm mortality
timeFrame: during the follow up period of 3 year
measure: Patency rate of branches
timeFrame: during the follow up period of 3 year
measure: Stroke
timeFrame: during the follow up period of 3 year
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Muenster University Hospital
Study officials:
affiliation: Department of Vascular and Endovascular Surgery University Hospital Münster
name: Alexander Oberhuber, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02263404: PINS Stimulator System to Treat Severe Anorexia Nervosa
Official title: PINS Stimulator System to Treat Severe Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anorexia Nervosa
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.


Eligibility criteria: Inclusion Criteria:

1. Female or male patients aged 20-60 years.
2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
3. Chronicity or treatment resistance shown by some or all of:

   * A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment.
   * A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding.
   * A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
   * Able to provide informed consent.
4. Able to comply with all testing, follow-ups, and study appointments and protocols.

Exclusion Criteria:

1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
3. Patients with serious infectious disease.
4. Patients with history of serious neurological or psychiatrical diseases.
5. Person with history of HIV infection or serious malnutrition.
6. Dependent upon and addicted to multiple drugs.
7. Any contraindication to MRI or PET scanning.
8. Body-mass index less than 13.
9. Attended some other trials within one year.

Primary outcomes:
measure: Eating Disorder Related Preoccupations and Rituals
timeFrame: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Change from baseline at 3 months, 6 months and 12 months
measure: Health Survey Short Form (SF-36)
timeFrame: Change from baseline at 3 months, 6 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References: