louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04093011: Perioperative Outcome of Congenital Heart Disease Surgery in Childhood
Official title: Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 6500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 1 week-18 years underwent congenital heart disease surgery from different Chinese regions.

Brief summary: Congenital heart disease is the most common congenital malformation in the world with high morbidity and mortality. However, there is no data to assess the perioperative outcome of congenital heart disease surgery among Chinese cross-regional population. This study aims to investigate the perioperative outcome of congenital heart disease surgery in childhood from a chinese cross-regional cohort.


Eligibility criteria: Inclusion Criteria:

* Subject was aged 1 week-18 years
* Subjects underwent congenital heart disease surgery;
* Available data to investigate perioperative outcome.

Exclusion Criteria:

* Cardiac reoperation;
* Emergency surgery;
* Interventional procedure within prior 30 days prior to surgery;
* Missing outcome data.

Primary outcomes:
measure: Rate of systemic inflammatory response syndrome
timeFrame: postoperative day 7 or hospital discharge, whichever occurred first.
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
state: Tianjin
Study officials:
affiliation: Peking Union Medical College
name: Hong Liu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04442711: Cohort of IPF Patients Experiencing an Exacerbation
Official title: Pulmonary Fibrosis Biomarkers During Exacerbation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Exacerbation
Hospitalization
Biomarkers
Outcome
Prognosis
Diagnosis
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 50
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 already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.

Brief summary: Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.

In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.

Detailed description: The aim of this study is to investigate the diagnostic and prognostic value of clinical and blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring hospital admission in patients with IPF.

Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.

Patients are recruited within 24 hrs. from hospital admission with respiratory worsening, where clinical data, and blood samples are collected. The blood samples are investigated for the same blood biomarkers as PFBIO.

Patient related outcomes are also collected, including quality-of-life questionnaires and outcomes of the exacerbations.

Eligibility criteria: Inclusion Criteria:

* Admitted with an increase in respiratory symptoms
* Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
* Age at least 18 years

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Biomarker levels
timeFrame: 30 days
measure: LTOT
timeFrame: 30 days
measure: QoL
timeFrame: 30 days
measure: Respiratory support
timeFrame: 30 days
measure: Decline in functional level
timeFrame: 30 days
measure: Treatment during hospitalization
timeFrame: 30 days
measure: Treatment after hospitalization
timeFrame: 90 days
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
state: Copenhagen
Study officials:
References:
Clinical trial NCT01816711: Vitamin D Levels in Frail Elderly Patients With a Hip Fracture
Official title: Vitamin D Levels in Frail Elderly Patients With a Hip Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Vitamin D Deficiency
Keywords: Frail elderly
Hip fracture
Vitamin D
Geriatrics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 447
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases were frail elderly admitted with a hip fracture to the Orthopaedic Ward at Aarhus University Hospital in the period: 18th of January 2010 to the 1st of October 2012.

Brief summary: The purpose of this study is to assess whether all frail elderly admitted with hip fracture has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in frail elderly.

Frail elderly are defined as being 65 years of age or older, and living in nursing homes or senior housings.

The investigators' hypotheses state that:

1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.
2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D than frail elderly without any hip fractures during the last ten years.

Detailed description: The study examined frail elderly patients, defined as 65 of age or older and living nursing homes or senior housings.

Cases where taken from a Randomised Controlled Trial (NCT01102010), where the included where frail elderly admitted with a hip fractures to the Orthopaedic Surgery Ward at Aarhus University Hospital.

Controls were frail elderly, without a hip fracture in the previous ten years, admitted to the Geriatric Ward at Aarhus University Hospital.

The investigators will look at all eligible patients' files and record their serum-25(OH)D levels upon admission.

According to sample size calculations 92 patients are needed in the case group, and 138 patients in the control group.

The inclusion period will be from the 18th of January 2010 to the 1st of October 2012 for both groups.

Eligibility criteria: Inclusion Criteria, Cases:

* Aged 65 or older
* Living in nursing home or senior housing
* Admitted with hip fracture to the Orthopaedic Ward, Aarhus University Hospital

Exclusion Criteria, Cases:

* No serum-25(OH)D measurement upon admission

Inclusion Criteria, Controls:

* Aged 65 or older
* Living in nursing home or senior housing
* Admitted to the Geriatric Ward, Aarhus University Hospital

Exclusion Criteria, Controls:

* No serum-25(OH)D measurement upon admission
* Hip fracture in the previous ten years

Primary outcomes:
measure: Number of Participants With Suboptimal and Optimal Levels of Vitamin D (Serum-25(OH)D)
timeFrame: Upon admission
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Reasearch Unit, Geriatric Department, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT03593811: Noninvasive Markers of Functional Nausea in Children
Official title: Noninvasive Markers of Functional Nausea in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Nausea
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The researchers propose to study how functional nausea in adolescents may be characterized noninvasively by the use of multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings.

Detailed description: 5/23/25. Study record updated to reflect Early Phase I trial as opposed to "N/A". The main aims were to develop a mathematical model of FN, correlate functional differences in slow waves in FN patients using modeling and experimental approaches, and to characterize biophysical, clinical, and psychosocial phenotypes of FN using newly developed diagnostic devices of EGG/MGG.

Functional nausea (FN) is a GI disorder that affects millions of Americans, particularly adolescents, but diagnoses remain largely exclusionary relying on symptomology with an otherwise normal diagnostic workup.

Successful completion of the project could contribute to understanding the altered physiology of functional nausea (FN), to stratification of FN patients according to physiological and/or psychological phenotypes, to improve diagnosis and provide objective measures of nausea and to inform and guide treatment options.

The analysis of slow wave activity represents the first physiologically-quantifiable noninvasive assessment method for pathological processes associated with functional nausea in adolescents.

Eligibility criteria: Inclusion Criteria:

* children ages 8-17 with functional nausea
* normal control participants ages 8-17 who have no known gastrointestinal complications

Exclusion Criteria:

* Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
* Normal participants with known intestinal complications
* Patients with cyclic vomiting syndrome, gastroparesis, malignancy, primary eating disorders, pregnancy, or hyperglycemia
* Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
* Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

Primary outcomes:
measure: Percentage of Normal Slow Waves (PNSW)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Alan Bradshaw, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251011: Effects of Physiotherapy Via Telerehabilitation in Patients With COVID-19
Official title: Effects of Physiotherapy Via Telerehabilitation on Cardiopulmonary, Physical, and Psychological Functions in Patients With COVID-19: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Long COVID-19
Cardiopulmonary Function
Physical Function
Lead sponsor: Chulabhorn Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.

Detailed description: A 2-armed, parallel-group, randomized controlled trial was conducted at Chulabhorn Hospital, Thailand on a convenience sample of patients who tested positive for COVID-19 using RT-PCR.

Eligibility criteria: Inclusion Criteria:

* Age between 20-60 years old
* Positive in COVID-19 testing
* Good communication and understanding
* Independent mobility

Exclusion Criteria:

* Cannot complete the study protocol

Primary outcomes:
measure: Cardiopulmonary function
timeFrame: at day 28 and 90 after positive in COVID-19 testing
measure: Patient's quality of life
timeFrame: at day 3 and 21 after positive in COVID-19 testing
measure: Functional capacity
timeFrame: at day 3 and 21 after positive in COVID-19 testing
measure: Anxiety and depression
timeFrame: at day 3 and 21 after positive in COVID-19 testing
measure: Insomnia
timeFrame: at day 3 and 21 after positive in COVID-19 testing
measure: Cognitive function
timeFrame: at day 3 and 21 after positive in COVID-19 testing
measure: Muscle strength
timeFrame: at day 3 and 21 after positive in COVID-19 testing
Secondary outcomes:
Other outcomes:
Locations:
city: Lak Si
country: Thailand
facility: Chulabhorn hospital
state: Bangkok
Study officials:
affiliation: Chulabhorn Royal Academy
name: Pooriput Waongenngarm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742311: EuroPainClinics® Study V (Prospective Observational Study)
Official title: EuroPainClinics® Study V (Prospective Observational Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Intervertebral Disc Herniation
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.


Eligibility criteria: Inclusion Criteria:

* lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI

Exclusion Criteria:

* The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent

Primary outcomes:
measure: 1.Pain as assessed by the Visual analogue scale All acquired information will be noted in to the special anonymous protocol
timeFrame: 3 years
Secondary outcomes:
measure: 2.Pain localization as assessed by note of radiating dermatome as neurologic examination
timeFrame: 3 years
measure: 3.Pain progress as assessed by global pain scale
timeFrame: 3 years
measure: 4. Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
timeFrame: 3 years
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: Europainclinics algesiology ambulance
Study officials:
affiliation: Director
name: Miroslav Burianek, MD MPH
role: STUDY_CHAIR
References:
Clinical trial NCT06677411: Vitamin D Status Fluctuations Over One Academic Year in Students
Official title: Annual Fluctuation of Vitamin D Nutritional Status in Students and Its Association with the Occurrence of Inflammation, Depressive States, and Cognitive Abilities
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitamin D Deficiency
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes students of both sexes at the age of 18-30 years who agree to participate and attend all four study meetings over one academic year. The participants should be in good health condition.

Brief summary: The main objective of the study is to assess changes in the concentration of vitamin D metabolite in serum throughout the academic year and to examine its relationship with the occurrence of inflammation indicators, dietary habits, nutritional status, severity of depressive states, and cognitive abilities in a group of students. An additional objective will be to assess the relationship between the genotype in the CYP2R1 gene and the concentration of 25(OH) vitamin D.


Eligibility criteria: Inclusion Criteria:

* no chronic diseases
* student status
* age 18-30 years

Exclusion Criteria:

* chronic diseases (related to malabsorption, kidney and liver diseases)
* not active student status
* age \<18 and \>30 years

Primary outcomes:
measure: Vitamin D concentration
timeFrame: 01.10.2024-01.10.2025
Secondary outcomes:
measure: Inflammation status measured with CRP
timeFrame: 01.10.2024-01.10.2025
measure: Depressive symptoms
timeFrame: 01.10.2024-01.10.2025
measure: Cognitive functions
timeFrame: 01.10.2024-01.10.2025
measure: Body composition
timeFrame: 01.10.2024-01.10.2025
measure: Dietary intake of vitamin D
timeFrame: 01.10.2024-01.10.2025
measure: CYP2R1 genotype
timeFrame: 01.10.2024-01.10.2025
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Life Sciences
state: Wielkopolska
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Sciences
name: Emilia Zawieja, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149511: Longitudinal Morphometric Changes Following SCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Foundation Wings For Life
First posted: 2014-05-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute and chronic patients with spinal cord involvement

Brief summary: In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the level of the lesion provides evidence of neural degeneration; however, the spatial and temporal patterns of progression and their relation to clinical outcomes are uncertain. New interventions targeting acute spinal cord injury have entered clinical trials but neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim to use MRI to assess neuronal degeneration above and below the level of the lesion after acute spinal cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic spinal cord injury and healthy controls. We assess patients clinically and by MRI at baseline, 2 months, 6 months, 12 months, and if possible 24 months and 60 months follow-up, and controls by MRI at the same timepoints. We assess cervical atrophy in white and gray matter and use cross-sectional spinal cord area measurements to assess atrophy at cervical level (C2/C3) and in the lumbar enlargement. We use myelinsensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps in the brain to assess microstructural changes associated with myelin. We also use diffusion tensor imaging acquired in the spinal cord at C2/C3 and in the lumbar enlargement to identify axonal loss and demyelination in the spinal white matter. Finally, we assess associations between MRI parameters and clinical improvement.


Eligibility criteria: Inclusion Criteria:

SCI patients:

* acute injury to the spinal cord
* no medical or mental illness
* written informed consent
* over the age of 18 years

Control subjects:

* over the age of 18 years
* written informed consent

Exclusion Criteria:

SCI patients:

* head or brain lesion associated with the trauma leading to the injury
* epileptic seizures
* MRI contraindications
* pregnant women or lactating women

Control subjects:

* pregnant women or lactating women
* MRI contraindications
* neurological or psychiatric illness

Primary outcomes:
measure: Cord and brain volume (mm^3) changes
timeFrame: Patients will be recruited within the first months of injury and scanned 6 times during the first 5 years post injury. Healthy controls will follow the same time line.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT03768011: Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications
Official title: A Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications to Help Reduce or Eliminate Use of Opiates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Chronic
Pain, Joint
Pain Syndrome
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a patient with joint pain, extremity pain, lumbar, thoracic and/or cervical pain, as part of the PI routine care or follows medical necessity and prescribes a combination topical cream and/or patch with or without non-narcotic oral medication independent of the study

Brief summary: purpose of this study is to evaluate the level of pain perceived by patients using a transdermal cream and/or transdermal patch with or without an oral medication as a pain management solution.

Detailed description: The purpose of this minimal risk, observational study is to observe and document patients' perspective on how the combination of transdermal cream and/or transdermal patch(s) with or without oral medication can help reduce or eliminate the use of opiate(s).

Eligibility criteria: Inclusion Criteria:

* Participants must be diagnosed with an ICD10 code indicative of chronic pain
* Participants must be starting a new regimen of topical therapy with or without non-narcotic oral medication that has been deemed medically necessary and is independent of the study
* Participants must be expecting to receive therapy for at least 12 weeks
* Participants must be between 18 and 64 years of age
* Participants must be able to provide sound verbal informed consent

Exclusion Criteria:

* Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)
* Participants must not have a diagnosis of cancer within the past 5 years
* Participants who have chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer

Primary outcomes:
measure: Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring pain from 0 no pain to 10 highest pain level.
timeFrame: 36 months
Secondary outcomes:
measure: Visual Analogue scales
timeFrame: 36 months
Other outcomes:
Locations:
city: Land O' Lakes
country: United States
facility: DCABM
state: Florida
Study officials:
References: