louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04300738: Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
Official title: Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Pulse Wave Velocity
Coronary Calcium Score,
Cardiovascular event,
Cardiovascular risk factor
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.

Is there a superiority of PWV compared to SCC:

Detailed description: Two method of cardiovascular risk screening are compared in patient going for Coronary Calcium Score measurement in a outpatient clinic. Ct Scann is expensive, learning time is for at least 2 years, and the reliability is operator dependent.

The Pulse Wave Velocity is measured using a new device with half an hour learning curve, and you get a result within 2 minutes.

1. A non-invasive medical device vs invasive
2. A better benefit-risk ratio
3. A lower diagnostic cost both for equipment and for qualification for use and learning time

Eligibility criteria: Inclusion Criteria:

1. Subject aged over 18
2. Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
3. Subject affiliated to a social security scheme or beneficiary of such a scheme
4. Lack of participation in another clinical study

Exclusion Criteria:

1. Minor patient
2. Patient with obliterating arterial disease of the lower limbs
3. Patient with Sore fingers and hands
4. Patient with arrhythmia that does not allow measurement of VOP
5. Patient with limb amputation
6. Major subject protected by law, under curatorship or tutorship

Primary outcomes:
measure: Coronary Calcium Score
timeFrame: 12 months
measure: Pulse Wave Velocity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Benkessou
Study officials:
References:
Clinical trial NCT06930638: MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes
Official title: MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: Ischemic Conditioning
Blood Flow
Microvascular Health
Flow-Mediated Dilation
Antioxidant
Reactive Oxygen Species
Supplement
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.


Eligibility criteria: Inclusion Criteria:

* 18 - 85 years of age
* Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
* Able to give informed consent and follow 2-step command.
* English Speaking

Exclusion Criteria:

* Unable to stand from chair without physical assistance from another person (able to use assistive device).
* History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
* Chronic lasting symptoms (\> 6 months) of severe COVID-19 (i.e., hospitalization)
* History of head trauma or concussion within the past 6 months
* Comorbid neurological disorder
* Peripheral vascular disease
* Myocardial infarction or arrhythmia in the previous year
* Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
* Pregnant or breastfeeding.
* Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator

Primary outcomes:
measure: Brachial Artery Flow-Mediated Dilation
timeFrame: Change from BL to Post Intervention (5 hours)
measure: Microvascular Vasodilation
timeFrame: Change from BL to Post Intervention (5 hours)
Secondary outcomes:
measure: Muscle Tissue Oxygenation
timeFrame: Change from BL to Post Intervention (5 hours)
measure: Blood Draw
timeFrame: Change from BL to Post Intervention (5 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wisconsin
name: Matthew Durand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04590638: Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Official title: Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Time
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to appraise if various concentration of adrenaline containing tumescent has any significant role in bleeding at skin graft donor site bleeding through photographic assessment.

Detailed description: Tumescent solutions will be prepared by adding 30cc of Ringer's lactate and 10cc of lignocaine 2%, with 1cc of adrenaline of 1:200,000 (which will be prepared by adding 1cc of adrenaline of 1:1000 conc. with 200ml of normal saline marked as solution "A" and without adrenaline marked as solution "B" to form the two different tumescent solutions. Both solutions with be topically applied in soaked gauzes for around 10 minutes. Solution A will be applied over the anterior side of thigh while solution B will be applied over lateral side of thigh.

Tumescent solutions will be prepared around 10 minutes before applying. After 10 min Split-thickness skin graft donor sites will be harvested with a Dermatome adjusted on with a randomized setting to harvest a fixed depth of wound depth. After harvesting skin graft the donor site wound will be photographed.

The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons. At last photographs will be compared with pre-infiltration records in each side. Skin graft donor and recipient site will be inspected on the 5th post-operative day

Eligibility criteria: Inclusion Criteria:

* age above 18 years

  * both genders
  * non hypertensive patients
  * Hemoglobin levels more than 10 g/dl
  * Platelet count above 150 x 10E9/L
  * Wounds for more than 6 weeks

Exclusion Criteria:

* • Hypertensive patients,

  * Bleeding tendencies (Disorder),
  * Immune-compromised,
  * Familial history of bleeding

Primary outcomes:
measure: ordinal scale
timeFrame: 30minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Mahak
state: Sindh
Study officials:
References:
Clinical trial NCT03316638: A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors
Official title: Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 2 Cohorts
Primary purpose: TREATMENT

Brief summary: W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.

The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.

Detailed description: This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).

Eligibility criteria: Inclusion Criteria:

Dose escalation phase (cohort A1 and A2)

1. Male or female subjects age ≥ 18 years
2. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate
3. ECOG performance status 0 or 1
4. Adequate bone marrow, renal, hepatic at screening and at Baseline
5. Subject must have measurable diseases as per RECIST v1.1 criteria

Exclusion Criteria:

1. Symptomatic brain metastases, CNS tumors
2. Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
3. Subjects having ophthalmologic abnormalities
4. Active serious systemic disease (infection,organic or dysmetabolic desease)
5. Left ventricular ejection fraction (LVEF) \< 45% as determined by MUGA scan or echography at screening
6. QTc \> 470 msec on screening ECG or congenital long QT syndrome
7. Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)

Primary outcomes:
measure: Incidence of Specific Adverse Events
timeFrame: 28 days
measure: Incidence of Specific Adverse Events
timeFrame: From first administration up to 63 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: IUCT
city: Villejuif
country: France
facility: IGR
city: Barcelona
country: Spain
facility: VHIO
Study officials:
affiliation: Pierre Fabre Medicament
name: Eric Chetaille, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04411238: Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home
Official title: Skills of Home Helpers for a Better Quality of Life for Adults With Huntington's Disease Living at Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 participants, including 30 cases with Huntington's disease, 30 caregivers not concerned himself with the risk of developing the disease and 30 home helper worker for Huntington's disease patients.

Brief summary: Huntington's disease often brings together 3 types of symptoms at one time or another of the disease during its evolution: motor, cognitive and psychiatric. Management requires comprehensive and multidisciplinary health, social or medico-social support. Its development generates additional difficulties for professionals who very often qualify this disease as "very complex" because it leads to a deep and severe impairment of physical and intellectual capacities. The sick person gradually loses their autonomy and becomes dependent for the acts of daily life, hence the choice of this disease for our study. Our study is focused on the quality of life at home of patients followed by the Angers Reference Center, "expert" on neurogenetic pathologies.

Studies focusing on patients' quality of life at home have so far never been undertaken for a rare neurodegenerative disease like Huntington's disease.


Eligibility criteria: Selection Criteria:

Patient group :

* Genetic diagnosis of Huntington's disease
* Symptomatic patient
* Patient living at home
* Person able to carry out the interviews provided for in the study

Caregiver group :

* Person, defined within the meaning of the CNSA (National Solidarity Fund for Autonomy) as a natural caregiver, not concerned himself by the risk of developing the disease
* person able to carry out the interviews provided for in the study

Home Helper group :

- Professionals working at home with Huntington's disease patients employed by home help service providers.

Primary outcomes:
measure: Identify and compare the expectations and needs of patients with Huntington's disease, their caregivers, and home helpers, in terms of home support, based on interviews
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03329638: A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
Official title: A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myopia
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.

To investigate the dose response of DE-127.


Eligibility criteria: Inclusion Criteria:

* Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
* Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
* Distance vision correctable to logMAR 0.2 or better in both eyes
* Normal intraocular pressure of not greater than 21 mmHg in both eyes
* No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria:

* Amblyopia or manifest strabismus including intermittent tropia
* Ocular disorders that potentially affect myopia or refractive power
* Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
* Systemic disorders that potentially affect myopia or refractive power

Primary outcomes:
measure: Spherical equivalent
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
References:
Clinical trial NCT00261638: A Study of the Effect of Mental Health Promotion on Mental Health Index
Official title: A Study of the Effect of Mental Health Promotion on Mental Health Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Mental Health Promotion
Mental Health Index
Taiwan Mental Health Index scale
psychophysical health
education years over 9 years
normal people, especially joining Mental Health Foundation Promotions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: "Health" includes physical and mental aspects. The evaluation of "Mental Health" contains four domains: psychophysical health, perceived security of the living world, meaning and worth of life, satisfaction of family-social interaction.

We have established a Taiwan Mental Health Index scale based on literature review and experts' opinions in 2002. The reliability and validity were assessed to be satisfactory. This TMHI scale has been applied in nation-wide mental health surveys of 2002, 2003, and 2004.

In order to evaluate the effect of mental health promotion activities, this research project will adopt this TMHI scale as the assessment tool. 300 people will be recruited for study after signing the informed consent. The general population sample of 1076 subjects recruited in 2004, will be as the comparison sample. The difference in 4 dimensions of MHI will be analyzed between these two study groups. The 300 study subjects will be subcategorized into two groups of low and high attendance groups. The difference in MHI between groups will also be statistically examined using independent t-test. The statistical signification is set at α=0.05.

This study result will be as the reference for setting up effective mental health promotion program for general public.


Eligibility criteria: Inclusion Criteria:

* Normal people
* education years over 9 years
* with reading ability

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mental Health Foundation/ Wonderful Brain
Study officials:
affiliation: National Taiwan University
name: Hai-Gwo Hwu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180538: Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring
Official title: EPIVIEWS: Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Keywords: wearable device
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Beaumont Hospital
First posted: 2023-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Epilepsy Monitoring Unit in Beaumont Hospital who have a history of tonic-clonic seizures

Brief summary: The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Detailed description: Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life.

New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers.

Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Eligibility criteria: Inclusion Criteria:

1. The participant is over the age of 18
2. The participant has access to a smartphone
3. The participant has a history of generalised tonic-clonic seizures in the past year

Exclusion Criteria:

1. The participant lacks capacity to give informed consent (e.g. has intellectual disability)
2. The participant is a paediatric patient (aged below 18)

Primary outcomes:
measure: Quality of Life in Epilepsy Inventory (QOLIE-31)
timeFrame: Prior to admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01367938: Clinical Outcomes With Omni Apex Ultracongruent Knee System
Official title: OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Total Knee Replacement
Total Knee Arthroplasty
TKA
Knee
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing total knee replacement

Brief summary: A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.


Eligibility criteria: Inclusion Criteria:

* Patients willing to sign the informed consent.
* Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
* Male and non-pregnant female patients ages 21-80 years of age at time of surgery.
* Patients requiring a primary total knee replacement.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients with a history of total or unicompartmental reconstruction of the affected joint.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days).
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients that computer-assisted surgical navigation (CAOS) techniques will be used.
* Patients that minimally invasive surgical technique will be used.
* Patients that are prisoners.

Primary outcomes:
measure: Clinical outcomes
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David F Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: