louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04941794: Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
Official title: Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Chronic Heart Failure
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2021-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients with known type 2 diabetes who are treated at the department of endocrinology, North Denmark Regional Hospital.

Brief summary: A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Detailed description: A cohort study on 500 patients with type 2 diabetes without known heart disease and age \> 50 years of age. On inclusion and on yearly basis, patients are evaluated by echocardiography, ECG, blood tests to examine NT-ProBNP, hs-CRP, troponin, kidney function and 6 minutes hall walk test.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* age \> 50 years

Exclusion Criteria:

* History of acute or chronic heart failure
* History of ischemic heart disease

Primary outcomes:
measure: Chronic Heart Failure
timeFrame: During 5 year follow up
Secondary outcomes:
measure: NT-ProBNP
timeFrame: During 5 year follow up
measure: hs-CRP
timeFrame: During 5 year follow up
measure: Troponin
timeFrame: During 5 year follow up
measure: 6 minutes walk test
timeFrame: During 5 year follow up
Other outcomes:
measure: HOMA-IR
timeFrame: During 5 year follow-up
Locations:
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
Study officials:
affiliation: Department of Cardiology
name: Steen Hylgaard Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421394: Spinal Cord Injury Series of Tampere - Retrospective Study
Official title: Spinal Cord Injury Series of Tampere - Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injury
Keywords: spinal cord injury(SCI)
diffusion tensor imaging(DTI)
tractography
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: spinal cord injured patients in "PSHP"(pirkanmaan sairaanhoitopiiri) area

Brief summary: This prospective study will assess thoroughly functional deficits and their significance in the light of rehabilitation in spinal cord injured patients.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of spinal cord injury

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere university hospital
Study officials:
References:
Clinical trial NCT05257694: Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning
Official title: A Deep Learning Model Based on Contrast-enhanced Ultrasound to Aid Clinical Decisions and Predict Biological Biomarker and Prognosis of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Contrast-enhanced Ultrasound
Prognosis
Surgery
Ablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with HCC corresponding to Ia, Ib, IIa stage (China liver cancer staging) who undergo resection or ablation.

Brief summary: Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Detailed description: Collecting CEUS and clinical data of HCC from different institutions retrospectively.

Developing a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients.

Then, validating the deep learning model in the prospective data.

Eligibility criteria: Inclusion Criteria:

* patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation
* without macro-vascular invasion
* Child-Pugh A/B grade
* HCC is proved by pathological examination or two enhanced imaging
* CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation
* Invasive biomarker or prognosis of HCC available
* CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)

Exclusion Criteria:

* postop follow-up loss or expired less than 3 months
* patients with co-malignancy
* poor images quality for analyzing

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: Immediately after the surgery or ablation
Secondary outcomes:
measure: Recurrence
timeFrame: Immediately after the surgery or ablation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02744794: Evaluation of a New Dermal Cryotherapy System
Official title: Evaluation of a New Dermal Cryotherapy System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lightening
Lead sponsor: R2 Dermatology
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

Detailed description: This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Fitzpatrick skin type VI.
2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
3. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
4. Dermatological conditions or scars in the location of the treatment sites
5. History of melanoma, personal or first degree relative
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with study requirments.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Primary outcomes:
measure: Skin pigmentation changes
timeFrame: 90 days
Secondary outcomes:
measure: Evaluation of device- or procedure-related adverse events
timeFrame: 0 to 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Center of Dermatology and Laser Surgery
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Miami
country: United States
facility: Bowes Dermatology
state: Florida
Study officials:
affiliation: R2 Dermatology, Inc.
name: Kristine Tatsutani, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00796094: Imaging of Soft Tissues
Official title: Elasticity Imaging of Soft Tissues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Injury
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-11-24
Enrollment: 30
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: Males and non pregnant females with soft tissue abnormalities.

Brief summary: The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures.

The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.

Detailed description: This is a prospective study that will recruit males and females 18 years of age and older who present to the department for a clinically indicated ultrasound of a superficial soft tissue abnormality with prior or following MRI / CT assessment ordered for clinical purposes.

The elasticity properties of tissues depend on their molecular building blocks and on the organization of these blocks. Injuries, disease etc are known to be associated with changes in tissue elasticity. Little research has been done on the potential of sonoelastographic (elasticity ultrasound imaging) assessment of normal, injured or healing muscles, tendons or ligaments.

Elasticity changes in muscle, ligaments and tendons following injury may have implication on the choice of treatment and help in determine how the length of time needed to heal from an injury.

Stiffness/elasticity of the tissue can be assessed by mechanical excitation with measurement of resultant tissue motion. Reconstruction of the elastic deformability (strain imaging) in real time ultrasound is known as sonoelastography.

Elasticity ultrasound imaging will be performed on the area being evaluated clinically.

Eligibility criteria: Inclusion Criteria:

* Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality.

Exclusion Criteria:

* Women who are pregnant

Primary outcomes:
measure: To assess the potential importance of Sonoelastography in evaluating tissue injury or abnormalities of soft tissues.
timeFrame: hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yoav Morag, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410994: Bariatric Surgery and the Kidney
Official title: Study of Renal Parameters After Bariatric Surgical Weight Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proteinuria
Keywords: glomerular filtration rate
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bariatric surgery patients in the Indianapolis region

Brief summary: The purpose of the project is to study the relationship between post-bariatric surgery changes in weight and renal parameters.


Eligibility criteria: Inclusion Criteria:

* bariatric patients

Exclusion Criteria:

* age \<18
* dialysis dependency

Primary outcomes:
measure: GFR
timeFrame: April 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT05867394: The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Official title: The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary angiography
stress
anxiety
vital signs
Lead sponsor: Aksaray University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective Randomized Controlled Clinical Trial
Primary purpose: PREVENTION

Brief summary: It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

Detailed description: Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.

Eligibility criteria: Inclusion Criteria:

* 18 years and over
* For those who will undergo coronary angiography for the first time
* Able to read and write
* Not diagnosed with anxiety disorder and not using medication for it
* No physical disability to use the stress ball
* Cognitive health levels consist of individuals who are suitable for answering data collection forms.

Exclusion Criteria:

* Unconscious and not fully oriented
* Sight and hearing problems
* Alzheimer's disease and other types of dementia
* Having a severe psychiatric problem that cannot answer the questions
* Those who came with MI (myocardial infarction) and performed CAG
* Individuals who are closed to communicating are not included in this study.

Primary outcomes:
measure: State Anxiety Score
timeFrame: Change in state anxiety score within one day
Secondary outcomes:
measure: Distress Thermometer
timeFrame: Only on day 1, 2 times a day (same day).
measure: Systolic Blood Pressure Value (mmHg)
timeFrame: Only on day 1, 2 times a day (same day).
measure: Diastolic Blood Pressure Value (mmHg)
timeFrame: It will be measured 3 times a day (same day) on day 1 only.
measure: Heart Rate/Minute Value
timeFrame: It will be measured 3 times a day (same day) on day 1 only.
measure: Respiratory Rate/Minute Value
timeFrame: It will be measured 3 times a day (same day) on day 1 only.
measure: Peripheral Oxygen Saturation (SpO2) Value
timeFrame: It will be measured 3 times a day (same day) on day 1 only.
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aysel SESCİ
state: University
Study officials:
References:
Clinical trial NCT06357494: Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease
Official title: Assessment of Thyroid Doppler Ultrasound in Relation to Clinical and Laboratory Parameters in Follow up of Pediatric Graves' Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Graves' Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children who will come at pediatric endocrinology outpatient clinic of Assiut University Children's Hospital meeting our inclusion criteria.

Brief summary: All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.

Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.

Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.

Doppler ultrasound will be done at 0, 12 and 24 months.


Eligibility criteria: Inclusion Criteria:

* All newly diagnosed children with clinical and laboratory hyperthyroidism (high T4 \& low TSH) with positive TRAbs.

Exclusion Criteria:

* Patients receiving radioiodine Patients underwent thyroid surgery History of neck radiation or neck surgery

Primary outcomes:
measure: thyroid volume
timeFrame: 3 years
measure: number of vessels per square cm of thyroid gland
timeFrame: 2 years
measure: inferior thyroid artery peak systolic velocity
timeFrame: 2 years
measure: end diastolic velocity
timeFrame: 2 years
measure: resistive index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02138994: Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Official title: Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Chronic Draining
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: Jacksonville Center For Clinical Research
First posted: 2014-05-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older
* Presence of full-thickness wound for more than one month (i.e. chronic)
* Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
* NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
* Willing to comply with all study procedures and be available for the duration of the study
* Provide signed and dated informed consent

Exclusion Criteria:

* Subjects unable to provide signed and dated informed consent
* Male or female less than 18 years old
* Presence of a full-thickness wound for less than one month
* A candidate for vascular reconstructive surgery to restore blood flow to the wound
* Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
* Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
* Subject with known allergic reaction to the study products

Primary outcomes:
measure: Wound Size Reduction
timeFrame: 2, 4, 8 and 12 weeks
Secondary outcomes:
measure: Wound Closure
timeFrame: 2, 4, 8 and 12 weeks
Other outcomes:
measure: Reduction of bacterial species types and amounts
timeFrame: 0 and 4 weeks
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research - RCCR location
state: Florida
Study officials:
References:
Clinical trial NCT03198494: Acoustic Stimulation for Seizure Suppression
Official title: Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression

Detailed description: 1. To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
2. To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* Able to provide informed consent
* MOCA ≥26
* Fluent in English
* Frequent nocturnal IEDs (≥ 10% of the sleep record)
* Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
* Frequent nocturnal seizures (≥1 per week)

Exclusion Criteria:

* Hearing impairment
* Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
* Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
* Seizures ≤ 24 hours prior to study.
* Alcohol or recreational drug use in the 24 hours prior to the study
* BMI ≥ 30
* MOCA \<26
* History of recent travel across time zones within the 1 month prior to study activities
* Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
* No medication changes at least 1 month before study, and during 3 months of study activities

Primary outcomes:
measure: Successful System Training
timeFrame: 72 hours
measure: Interictal Discharge frequency
timeFrame: 72 hours
measure: System Adherence
timeFrame: 2 months
Secondary outcomes:
measure: System Use effect on Features of Sleep
timeFrame: 72 hours
measure: Seizure Control
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anli Liu
role: PRINCIPAL_INVESTIGATOR
References: