louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06438835: Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)
Official title: Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 4
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pneumatic Artificial Muscles (PAMs), inspired by the structure and function of natural muscles, offer a lightweight and adaptable solution compared to traditional rigid Ankle Foot Orthosis(AFOs).

Detailed description: The development process involves design optimization to ensure proper, fit, functionality and durability. Researchers utilize advanced materials and manufacturing techniques to create PAMs that mimic the natural movement of the ankle joint while providing sufficient support and flexibility. Evaluation of PAMs involves rigorous testing in both laboratory settings and real world environments. Bio-mechanical analysis assesses the performance of PAMs during various activities such as walking, running and stair negotiation. Critical trails involving patients with AFOs provide valueable feedback on usability, comfort and overall satisfaction. Additionally, long-term studied monitor the durability and reliability of PAMs over extended periods of use. Overall, the development and evaluation of PAMs for patient with AFOs represent a significant advancement in assistive technology. By offering a more natural and adaptive solution for gait assistance, PAMs enhance mobility, independence and quality of life for individuals with mobility impairments.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of droop foot
* Ability to tolerate pneumatic pressure
* Sufficient muscle strength activation

Exclusion Criteria:

* Allergy to materials used in device fabrication
* Severe muscle weakness preventing activation
* Uncontrolled hypertension, pregnancy.

Primary outcomes:
measure: Functional Mobility
timeFrame: 12 months
measure: Range of motion (ROM)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Al-Ghani rehabilitation centre. Opposite to Misaq-ul-mall
state: Punjab
Study officials:
References:
Clinical trial NCT05795335: CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
Official title: Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Locoregionally Recurrent
Metastatic
CDK4/6 Inhibitors
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.

Brief summary: This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 and older
* Confirmed diagnosis of hormone receptor-positive breast cancer.
* Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
* ECOG 0-2
* Adequate organ function

Exclusion Criteria:

* Subjects disable to swallow pills.
* History of immunodeficiency disease

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
measure: Adverse events
timeFrame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT02219035: A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).
Official title: A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: presentation with
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 200
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: all acute admissions presenting with ? stroke

Brief summary: In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13 levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global haemostasis will be assessed using thrombin generation and the relation between increase thrombin generation and VWF explored. Thrombin generation will be performed pre and post filtration for the presence of procoagulant microparticles. These parameters will be investigated acutely, at presentation and in convalescence; in addition, the effect on these parameters of treatment such as thrombolysis may be informative. Correlation between measured parameters and adverse clinical outcome would be used to identify markers of severity and progression of ischaemic stroke and identification of potential novel approaches to therapy that might improve outcome.


Eligibility criteria: Inclusion Criteria:

* Patients aged \>18 years of age presenting within 9 hours of onset of symptoms will be recruited from the hyperacute stroke unit at UCLH.
* Patients in whom stroke has been excluded or in whom intracerebral haemorrhage has been diagnosed are to be included as 'controls'. The definitive diagnosis will not be immediately obvious at presentation.
* Written consent will be obtained from patients or their nearest relative, particularly in patients with aphasia/dysphasia.

Exclusion Criteria:

* Patients \<18 years old
* Patients with systemic vasculitis or active malignancy will be excluded.
* Patients not wishing to participate

Primary outcomes:
measure: Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: UCLH
name: Marie Scully
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02606435: Thrombus Aspiration in Patients With STEMI
Official title: Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).

Detailed description: This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.

Eligibility criteria: Inclusion Criteria:

* Age between 18-80;
* Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
* Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
* Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
* Informed consent.

Exclusion Criteria:

* Previous history of myocardiopathy, valvular heart disease or severe heart failure;
* Severe hepatic or renal dysfunction;
* Life expectancy less than 1 year;
* Prior PCI or CABG;
* Contraindications of using anticoagulation or antiplatelet drugs.

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with stent thrombosis
timeFrame: 1 year
measure: Number of participants with target vessel revascularization
timeFrame: 1 year
measure: left ventricular function
timeFrame: 1 year
measure: Seattle Angina Questionnaire scores
timeFrame: 1 year
measure: 6-minute walk distance (6MWD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Dongdong Sun, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398535: Ultrasound Versus Magnetic Reseonance Imaging(MRI) in the Assessment of Anterior Knee Pain
Official title: Ultrasound Versus Magnetic Reseonance Imaging(MRI) in the Assessment of Anterior Knee Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Knee Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Adults who presented by knee pain , limitation of movement at knee.

Brief summary: Anterior knee pain , often known as patellofemoral pain syndrome (PFPS), is a prevalent orthopedic ailment. It usually happens while you're bending your knees. It can affect people of all ages, although it is most common among teenagers, young adults, and athletes .

The actual etiology of anterior knee pain might be complicated, encompassing a variety of conditions; it causes disability, discomfort and a negative impact on the quality of life

. A number of diagnostic techniques, including plain radiography, computed tomography, MRI, arthroscopy and ultrasound are used to identify the pathologies causing anterior knee pain. Arthroscopy, though accurate, is invasive and can cause complications. Palin radiographs and computed tomography expose patients to radiations


Eligibility criteria: Inclusion Criteria:

* Adults who presented by knee pain , limitation of movement at knee.

Exclusion Criteria:

* Knee trauma, non-cooperative patients and those who refuse to participate, contraindications to magnetic resonance imaging, such as patients with cardiac pacemakers, metallic plates, and claustrophobia.

Primary outcomes:
measure: sensitivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Crossley KM, Callaghan MJ, van Linschoten R. Patellofemoral pain. BMJ. 2015 Nov 4;351:h3939. doi: 10.1136/bmj.h3939. No abstract available.
citation: Samim M, Smitaman E, Lawrence D, Moukaddam H. MRI of anterior knee pain. Skeletal Radiol. 2014 Jul;43(7):875-93. doi: 10.1007/s00256-014-1816-7. Epub 2014 Jan 29.
citation: Sanchis-Alfonso V, Dye SF. How to Deal With Anterior Knee Pain in the Active Young Patient. Sports Health. 2017 Jul/Aug;9(4):346-351. doi: 10.1177/1941738116681269. Epub 2016 Nov 1.
citation: Alves TI, Girish G, Kalume Brigido M, Jacobson JA. US of the Knee: Scanning Techniques, Pitfalls, and Pathologic Conditions. Radiographics. 2016 Oct;36(6):1759-1775. doi: 10.1148/rg.2016160019.
Clinical trial NCT00266435: The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing
Official title: The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Asymptomatic subjects
Moderate to high risk for cardiovascular event
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-16
Enrollment: 371
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary prevention program

Brief summary: The main objective of this study is to compare the sensitivity and specificity of a new system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a conservative treadmill test in asymptomatic subjects, classified by Framingham score as moderate to high risk. Subjects will perform a routine exercise test with the addition of another set of electrodes to record high resolution ECG. All subjects will perform a stress echocardiography. The result of the routine ECG analysis will be compared to the new system and to the echocardiography results.


Eligibility criteria: Inclusion Criteria:

* A patient referred to annual screening check
* Classified as being at intermediate or high risk for the development of cardiovascular disease by the Framingham score.
* Signed an Informed Consent Form

Exclusion Criteria:

* A subject who cannot or should not perform an exercise test.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ehud Schwammenthal, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602835: Human Urine Sample Collection for Alport Nephropathy Biomarker Studies
Official title: Human Urine Sample Collection for Alport Nephropathy Biomarker Studies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alport Syndrome
Keywords: Alport syndrome
proteinuria
glomerular disease
hereditary nephropathy
nephropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Alport syndrome identified by the Alport Syndrome Treatments and Outcome Registry (ASTOR)

Brief summary: This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function.

The purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as Alport nephropathy.


Eligibility criteria: Inclusion criteria:

* Alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping)
* Physically able to provide a single first-morning urine sample of at least 30 mL

Exclusion criteria:

* Diagnosis of chronic kidney disease
* Receiving chronic phosphate-lowering therapy or erythropoietin therapy
* Ongoing chronic hemodialysis therapy and/or renal transplant recipient
* Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06336135: Reduction in Symptoms After Laser Therapy With Acorn aHFS
Official title: A Prospective, Single-blind, Randomized, Placebo-controlled, Clinical Trial Evaluating Reduction in Severity and Duration of Symptoms After Laser Therapy With Acorn aHFS
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Skin Aging
Keywords: skin, aging, rejuvenation, laser resurfacing, autologous secretome
Lead sponsor: Acorn Biolabs Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are healthy adults receiving laser skin rejuvenation therapy.

Brief summary: This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Age: ≥18 and ≤60 years
* Any skin tone Fitzpatrick score 1-2 (light), 3-4 (medium), 5-6 (dark)
* Competent and willing to provide written, informed consent to participate in all study activities

Exclusion Criteria:

* Pregnant women
* Are participating/have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by Sponsor
* Use of retinoids 7 days prior to the procedure
* Active cutaneous infections in the treatment area
* Diseases that could inhibit healing, such as scleroderma, or other cutaneous conditions that could confound study results
* Subjects unable to communicate with the investigator and staff
* Any health condition that in the investigator's opinion should preclude participation in this study

Primary outcomes:
measure: Reduction in severity and duration of symptoms
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Markham
country: Canada
facility: Rejuuv Medi Spa
state: Ontario
Study officials:
affiliation: Acorn Biolabs Inc.
name: Liis Teene
role: STUDY_DIRECTOR
References:
Clinical trial NCT06497335: Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis
Official title: Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis: a Validation Study in Gynecological Surgery Department of Angers 's University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anemia
Keywords: post operative screening
anemia
iron deficiency
diagnosis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-07-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population of gynecological surgical department

Brief summary: Non invasive Hemoglobin monitoring by SpHb device had been developed to assess Hemoglobin level during hemorrhagic surgery. It's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. This study aims to valid these finding on a cohort of post operative patients from gynaecological department.


Eligibility criteria: Inclusion Criteria:

* being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
* \> 18 years

Exclusion Criteria:

* non french speaker
* being under a legal individual protection measure
* not being able to consent
* being opposed to data collection

Primary outcomes:
measure: accuracy between SpHb measure and Hemoglobin level on the post operative blood sample
timeFrame: at 2 and 8 months after establishment of PBM protocol
Secondary outcomes:
measure: Spearman correlation coefficient
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: Kappa coefficient
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: Intra class correlation coefficient
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: Subgroup analysis of ROC curve (classes of age 18-30; 30-40; 40-50; >50)
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: impact of body temperature on accuracy of SpHb
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: impact of perfusion index on accuracy of SpHb
timeFrame: at 2 and 8 months after establishment of PBM protocol
measure: impact of leght between SpHb measurement and laboratory Hb measurement on accuracy
timeFrame: at 2 and 8 months after establishment of PBM protocol
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: Sigismond Lasocki
role: PRINCIPAL_INVESTIGATOR
References: