louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06421961: Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
Official title: Digital Techniques for Measuring Chronic Leg Ulcers in Peripheral Arterial Disease: Aspects of Measurement Precision and Evaluation of Wound Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Limb-Threatening Ischemia
Keywords: Wound Healing
Artificial Intelligence
Digital Technology
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patienten seeking care and being diagnos with peripheral arterial disease and having hard to heal wounds on lower leg or foot.

Brief summary: The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.


Eligibility criteria: Inclusion Criteria:

* Adults with peripheral arterial disease.
* Arterial or arteriovenous ulcers on lower leg
* Age \<18

Exclusion Criteria:

* Adults with non-ischemic ulcers,
* Purely venous ulcers,
* Purely traumatic wounds,
* Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis),

Primary outcomes:
measure: To assess the clinical agreement between two methods of measuring arterial wound size, we will utilize the Bland-Altman plot.
timeFrame: Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
measure: To assess the clinical agreement between two methods of measuring the depth of arterial wounds, we will utilize the Bland-Altman plot.
timeFrame: Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy
name: Monica Ms Pettersson, PhD
role: STUDY_DIRECTOR
affiliation: Sahlgrenska University Hospital
name: Joakim Mr Nordanstig, PhD
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Sara Ms Haile, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01658761: Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Official title: Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maculopathy
High Myopia
Surgery
Keywords: Myopic traction maculopathy
vitrectomy
internal limiting membrane
Retrospective, case control study
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.

Detailed description: Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.

Eligibility criteria: Inclusion Criteria:

* Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy

Exclusion Criteria:

* Eyes with follow-up less than a year

Primary outcomes:
measure: Visual acuity
timeFrame: One year
Secondary outcomes:
measure: Optical coherence tomography
timeFrame: One year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912561: Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Official title: Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stenosis
Keywords: chronic brain ischaemia
stroke prevention
exercise
physical training
Chronic, extra- or intracranial stenoses of brain supplying arteries
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2009-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).

Detailed description: The primary objective: Intense aerobic exercise (24/8 weeks) improves CVR \> 20% measured by Transcranial Doppler (TCD) in patients with hemodynamic relevant intra- or extracranial stenoses by enhanced cerebral arterio- and angiogenesis.

Secondary objectives:

Intense aerobic exercise (24/8 weeks) leads to:

* an increase of Endothelial progenitor cell counts (EPCs)
* qualitative and quantitative changes of endothelial markers and cytokines representing the inflammatory activity of atherosclerosis and neovascularisation
* an improvement in cognitive performance and quality of life (QoL)
* changes of the mean vessel size and of cerebral perfusion

Eligibility criteria: Inclusion Criteria:

* high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD

Exclusion Criteria:

* continuous physical activity ≥ 60 min/week within the last 3 months
* cerebral bleeding or ischaemic stroke \< 3 months
* contraindications for spiro-ergometry, IAEx, or MRI

Primary outcomes:
measure: change of cerebrovascular reserve capacity
timeFrame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Secondary outcomes:
measure: Endothelial Progenitor Cells, cyto- and chemokines
timeFrame: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
measure: Neuropsychological Testing/ Quality of life
timeFrame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
Study officials:
References:
Clinical trial NCT06662461: Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Resistant Migraine and Correlation to Calcitonin Gene Related Peptide
Official title: Efficacy of Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Chronic Resistant Migraine Patients and Its Correlation to Calcitonin Gene Related Peptide (CGRP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: occipital nerve block
stellate ganglion block
migraine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ahmed Mohamed ElSadek
name: Sherien Mohamed Farag
name: Noha Lotfy Soliman
name: Mohamed Amir Tork
name: Ahmed Mohamed Abdelfattah Sharawy
First posted: 2024-10-29
Enrollment: 40
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: To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.

Detailed description: 40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.

Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months

Exclusion Criteria:

* Patients with a space-occupying lesion.
* Coagulation disorders.
* Systemic or local infection and drug allergies.

Primary outcomes:
measure: Changes in Headache impact test (HIT-6)
timeFrame: 3 months
measure: changes in Migraine disability assessment test (MIDAS)
timeFrame: 3 months
measure: changes in Numeric Rating Scale (NRS)
timeFrame: 3 months
Secondary outcomes:
measure: Changes in circulating CGRP level
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
Clinical trial NCT01879761: Immune Resolution After Staphylococcus Aureus Bacteremia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Immune Response To Sepsis
Staphylococcus Aureus Infection
Keywords: Immunosuppressed
Sepsis
Staphylococcus Aureus
Bacteremia
HLA-DR
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 102
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: Hospital inpatients with Staphylococcus aureus bacteremia who are over 18 years old.

Brief summary: The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia.

We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.


Eligibility criteria: Inclusion Criteria:

* At least one blood culture positive for S. aureus
* Patients aged ≥18 years
* At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:

  * Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F)
  * Heart rate greater than 90 beats per minute
  * Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg
  * WBC less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L); or the presence of greater than 10% immature neutrophils (band forms)

Exclusion Criteria:

* Sequential Organ Failure Assessment (SOFA) score \> 12 on day of positive blood cultures
* Survival expected to be \< 7 days from positive blood cultures

Primary outcomes:
measure: HLA-DR and cytokines
timeFrame: 0-30 days
Secondary outcomes:
measure: New Infections
timeFrame: 0-90 days
Other outcomes:
measure: Mortality
timeFrame: 0-90 days
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT06691061: The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Official title: Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis (Disorder)
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ulcerative colitis

Brief summary: The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
* Age ≥ 18 years-old;
* Capability of expressing informed consent;
* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
* At least 1 follow-up visit after baseline

Exclusion Criteria:

* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
* Age \< 18 years-old;
* Incapability of expressing informed consent;
* Acute severe UC requiring hospitalization at baseline;
* No previous exposure to anti-TNFα therapies;
* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.

Primary outcomes:
measure: Clinical and endoscopic effectiveness of the three treatments
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mialn
country: Italy
facility: Humanitas Research Hospital IRCSS
Study officials:
References:
Clinical trial NCT06860061: Changes of Higher-Order Aberrations After Different Types of LASIK in Myopia
Official title: Changes of Corneal and Total Ocular Higher-Order Aberrations After Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
Primary purpose: SCREENING

Brief summary: This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).


Eligibility criteria: Inclusion Criteria:

Age: 18 - 45 years old.

Refraction:

Low and moderate grades of myopia will be included:

(According to manifest refraction) low (\[0\] - ≤ \[-3\] diopters) Moderate (\[-3\] - ≤ \[-6\] diopters) With cylinder ≤ \[-1.5\] diopters.

Exclusion Criteria:

Any ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.

Primary outcomes:
measure: Changes of corneal higher-order aberrations
timeFrame: 1 year
measure: Changes of total ocular higher-order aberrations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02507661: Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes
Official title: Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Partial Edentulism
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.


Eligibility criteria: Inclusion Criteria:

* healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
* presence of 4 socket walls
* non-smokers
* good oral hygiene
* good occlusion

Exclusion Criteria:

* patients with alveolar ridge height less than 12 mm
* presence of acute or chronic oro-facial pain
* acute periapical infection
* injured soft tissue
* patients who had dental interventions in last 7 days
* patients who had any medications within last 24 hours
* patients with bruxism and para-functions
* patients with allergies to any of applied materials

Primary outcomes:
measure: implant stability analysis at the time of implant placement
timeFrame: baseline
measure: implant stability analysis 3 weeks after implant placement
timeFrame: baseline, 3 weeks
measure: implant stability analysis 6 weeks after implant placement
timeFrame: baseline, 6 weeks
measure: implant stability analysis 8 weeks after implant placement
timeFrame: baseline, 8 weeks
measure: change in pink and white esthetic score 2 months of loading
timeFrame: 2 months
measure: change in pink and white esthetic score 6 months of loading
timeFrame: 6 months
measure: change in pink and white esthetic score 12 months of loading
timeFrame: 12 months
Secondary outcomes:
measure: analysis of new bone formation 2 months after preservation of alveolar ridge
timeFrame: 2 months
measure: analysis of new bone formation 4 months after preservation of alveolar ridge
timeFrame: 4 months
measure: analysis of new bone formation 9 months after preservation of alveolar ridge
timeFrame: 9 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine, University of Belgrade
Study officials:
affiliation: School of Dental Medicine, University of Belgrade
name: Bozidar M Brkovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04000061: Heart Failure-USB: Prediction and Progression
Official title: Heart Failure-USB: Prediction and Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Heart Failure
Acute Coronary Syndrome
Heart Failure
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that were hospitalized at the Universitätsspital Basel/ Switzerland with the diagnosis of ACS or AHF during the years 2010 - 2023

Brief summary: This retrospective cohort study is to identify triggers of heart failure (HF) development and drivers of HF progression as well as the underlying cardiac disease (phenotype) to identify patients at risk and predict the clinical course of the disease. Data of patients who were hospitalized during the years 2010-2023 with acute coronary syndrome (ACS) and/ or with acute heart failure (AHF) will be collected and analyzed. In a subgroup cohort efficacy and safety of digoxin in patients with acute heart failure triggered by tachyarrhythmia will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized with a primary diagnosis of ACS
* Patients hospitalized with a primary or secondary diagnosis of AHF

Exclusion Criteria:

* Existence of a documented statement of the patient against the scientific use of clinical data

Primary outcomes:
measure: number of all-cause death
timeFrame: 1 to 8 years after hospitalization
measure: number of HF hospitalizations
timeFrame: 1 to 8 years after hospitalization
measure: number of cardiovascular death
timeFrame: 1 to 8 years after hospitalization
measure: number of cardiovascular hospitalizations
timeFrame: 1 to 8 years after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Cardiology, University Hospital Basel
Study officials:
affiliation: Cardiology University Hospital Basel
name: Christian Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399761: Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency
Official title: Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aromatic L-amino Acid Decarboxylase Deficiency
Keywords: AADC deficiency, newborn screening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 154795
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns whose parents agree to be tested

Brief summary: Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency.

Detailed description: Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency. The routine newborn screening dried blood spots sample will be used to test if 3-O-methyldopa (3-OMD) concentration elevates. If positive of screening test, further confirmation tests including physical examination and for mutation. Genetic counseling and treatment option will be provided, too.

Eligibility criteria: Inclusion Criteria:

* Babies born in Taiwan receive regular new born screening suggested by Ministry of Heath and Welfare.
* Parents or Legal Guardian sign in the informed consent form.

Exclusion Criteria:

* Parents or Legal Guardian do not agree to sign in the informed consent form.

Primary outcomes:
measure: Number of newborns with AADC deficiency
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: