cyrilzakka/clinical-trials huggingface dataset:
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study

Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.

The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.

Frailty concept has been created to screen the older people at risk for dependency and to propose preventive intervention. Muscle function is at the centre of the concept and the majority of interventions proposed to reverse or to prevent frailty have targeted physical function. Anatomical and functional alteration of muscle, called sarcopenia is defined as a low skeletal muscle mass, a decrease in strength (dynapenia or sarcopenia is the age-associated loss of muscle strength that is not caused by neurologic or muscular diseases) and functional consequences such as low gait speed. Qualitative analysis should be associated with quantitative (mass) analysis in older subjects assessed for frailty. Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI) can be used for this purpose. Brain changes were also reported to be associated with frailty. The study of structural changes associated with brain MRI alterations may better explain the frailty process.

Robust, frail and pre-frail subjects will be compared for clinical and MRI data. Grey matter volumes, white matter hyperintensities, diffusion tensor imaging data and muscle assessments relationships will be described After baseline assessment follow-up will be performed by phone calls after one month and after six months to record the number of falls and severity, the number of unscheduled hospitalization, the admission in institution for older people and death.

Eligibility Criteria:
Inclusion Criteria:

* Robust or frail or pre-frail with at least 25% frail and 25% pre-frail according to Frieds criteria
* Barthel index \> or = 60/100
* With or without diabetes mellitus, 45 to 55 % with known diabetes mellitus
* With no contraindication to undergo an MRI examination

Exclusion Criteria:

* not willing to participate
* not able to give informed consent or to understand basic instruction due to any problem (sensorial, educational, language)
* without social insurance
* with a legal protection
* with significant cognitive alteration (MMSe\<21/30 or in case of low literacy \<19/30)
* with a recent (2 month period) severe event: hospitalization, sepsis, stroke even with complete recovery, trauma
* with stroke sequelae (motor, speech)
Complex CAD Treated With PCI With DES Implantation.

COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.


Eligibility Criteria:
Inclusion Criteria:

* For the inclusion of patients in this study, the complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length \>40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).

Exclusion Criteria:

* left main stem
* PCI treated during index procedure;
* cardiogenic shock,
* thrombolysis before PCI;
* 12-month follow-up not available
Creative Arts II Study

The purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients.

Qualifying patients admitted to Epilepsy Monitoring Unit will be approached for participation in the study. Patients who consent will be randomly assigned to work with one of three creative artists (visual artist, creative writer, or therapeutic musician. The assigned artist will provide 1 intervention while the patient is admitted and 4 follow-up interventions after discharge from the hospital. Follow-up sessions will be conducted remotely, either by phone or over the internet.

Subjects will be asked to complete study questionnaires before and after the first art intervention, and again after the last follow-up session. The study seeks to measure the impact of arts interventions on quality of life. Secondary objectives include the effects of the interventions on seizure frequency and EEG spike generation, as well as the impact of creative arts interventions on patients diagnosed with non-epileptic events during hospitalization.\*

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Scheduled for admission to the Dartmouth-Hitchcock Medical Center Epilepsy Monitoring Unit for diagnostic Video/EEG monitoring
3. Capable of giving informed consent.
4. Able to follow instructions

Exclusion Criteria:

1. Active psychiatric illness that would interfere with participation with the artist.
2. Active general medical condition that would impair the participant's consciousness or ability to participate.
3. Any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.
Effect on Wound Healing of Vigamox Versus Cravit

The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any race and either sex, and over the age of 18, who are scheduled for removal of a cataract and implantation of a posterior chamber intraocular lens using clear corneal incisions or near-clear corneal incisions.
* Intraocular pressure (IOP) readings, treated or untreated, less than or equal to 20 mmHg prior to surgery. Glaucoma patients are eligible if an ocular hypotensive agent (only one) controls their IOP.
* Other than cataracts, have normal healthy eyes as determined by the ophthalmic examination and case history.
* Subconjunctival injections right after cataract surgery are allowed.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any cataract wound that is stitched or any gross abrasion of the epithelium after removal of a cataract and implantation of a posterior chamber intraocular lens.
* Fluorescein staining of the cornea at baseline.
* History or evidence of ocular or systemic disease, which would preclude participation in this study. Examples could include autoimmune disease affecting the cornea as well as any corneal dystrophies.
* History of ocular inflammatory disease, ocular herpes infection, iritis, uveitis, or Sjögren's syndrome.
* Known or suspected allergy or hypersensitivity to levofloxacin or any related medicines, such as cinoxacin (Cinobac), ciprofloxacin (Cipro or Ciloxan), norfloxacin (Chibroxin or Noroxin), ofloxacin (Floxin), or nalidixic acid (NegGram), preservatives, dyes, or any components of the study medication.
* Treatment for an ocular infection within 30 days prior to study entry.
* Use of topical or systemic steroids within 7 days prior to study entry.
* Use of topical anti inflammatory drugs within 7 days prior to study entry.
* Pregnancy, nursing/lactation, or inadequate birth control methods. Oral contraceptives are allowed.
* Patients with uncontrolled diabetes and/or diabetic retinopathy.
* No ointment is used after cataract surgery.
* Other protocol-defined exclusion criteria may apply.
Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia

The purpose of this research study is to examine the effect of percutaneous inferior cervical sympathetic block on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death.


Eligibility Criteria:
Inclusion Criteria:

1. Appropriate ICD shock for ventricular tachycardia (VT) after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT arising from an inaccessible myocardial location).
2. Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
3. Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
4. Age greater than 18 years old.
5. Able and willing to comply with all pre- and follow-up testing and requirements.
6. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.

Exclusion Criteria:

1. Active ongoing cardiac ischemia as assessed by: EKG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an exclusion criterion).
2. Any medical or non-medical condition likely to prevent completion of trial.
3. Contraindication to cardiac sympathetic denervation (i.e. single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure.
4. Left ventricular assist device or status post orthotopic heart transplantation
5. Severe thrombocytopenia (platelets \< 50,000) or coagulopathy (INR \> 2.0) that is not due to medications or a reversible cause.
6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
7. Unable or unwilling to comply with protocol requirements.
8. NYHA class IV heart failure symptoms.
9. Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
10. Presentation with slow VT (VT rate \< 150 bpm).
Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients

This randomized controlled trial aims to test if a combination of medical hypnosis and ear acupuncture improves sleep quality in patients with advanced cancer during a hospital stay in a palliative care unit.

Patients submitted to our palliative care unit will receive a medical hypnosis and ear acupuncture on the second day of their stay. Sleep quality will be measured using validated patient-reported outcome measures at baseline and after 7 days. Additionally, the use of sleep medication will be documented as a secondary outcome.

The intervention will be compared to a sham medical hypnosis and ear acupuncture to see if the effect of the true intervention has a unique effect.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed cancer
* RCSQ total score \<25mm
* ability to read and understand the questionnaires
* ability to give informed consent

Exclusion Criteria:

* pregnancy
* language barrier (non German)
* inability to give informed consent
* hypacusis
* radiographical verified brain metastases
* diagnosed psychosis
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents

The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c\<7%. Adolescents seem to need particularly a better metabolic control.

Working Hypothesis:

We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.

Objectives:

To show that nurse-counselling may improve levels of patient satisfaction.

Methodology:

The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".

This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.

The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
* HbA1c rate \> 8 %.

Exclusion Criteria:

* HbA1c \< 8 %;
* patients participating in another study
Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview

The goal of this clinical trial is to strengthen the understanding of advance care planning (ACP) in family members of older adults in residential care homes with a nurse-led, motivational interview (MI) educational intervention.The main question it aims to answer is: The feasibility of the nurse-led, motivational interview educational intervention to promote family members' understanding of ACP.

Participants will receive a nurse-led, motivational interview educational intervention to see if the nurse-led, motivational interview educational intervention works in strengthening family members' knowledge on ACP and readiness for initiating conversations on ACP with their loved ones.

Targeted issue: Lack of feasible method exists to empower family members of older adults in residential care homes to engage in advance care planning (ACP).

Population: Family members who are identified by a resident aged above 65 years old in residential care homes.

Intervention: A nurse-led, stage-tailored, motivational interview (MI) educational intervention.

Study aim: To evaluate the preliminary feasibility of the nurse-led, motivational interview educational intervention to promote family members' understanding of ACP.

Study method: This is a mixed-methods design, including an intervention trial and qualitative process evaluation interview. Participants will receive a nurse-led, motivational interview educational intervention and research staff will track their readiness for ACP at three-time points (before the intervention \[T0\], 2-week \[T1\], 3-week \[T2\] post-intervention). In addition, a post-intervention interview, regarding participants' experience of receiving the intervention, will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Identified by a resident aged above 65 years old in the residential care home as family member by the HA's definition
* Able to read and write in Chinese

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Severe hearing impairment, defined as unable to participate in a telephone conversation
* Primary language other than Cantonese or Mandarin
* No access to telephone
* Cannot read or write in Chinese
18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques

The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition intravascular ultrasound (IVUS).

In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan reproducibility.

This research involves having cardiac 18F-NaF PET imaging of the heart and coronary Computed Tomographic Angiography (CTA) in a one-day visit. Three groups of patients will be enrolled: patients with Acute Coronary Syndrome, patients with stable ischemic heart disease, and asymptomatic patients with suspected coronary artery disease.

Prior to 18F-NaF administration, participants will have blood drawn to measure serum creatinine and other biomarkers related to heart disease.

All participants will undergo a 18F-NaF PET scan and a coronary CTA (which includes contrast administration). If medically appropriate, participants will have oral or intravenous beta-blocker (metoprolol) and nitroglycerin prior to CTA imaging.

Up to 10 patients will be asked to return for repeat18F-NaF PET and coronary CTA imaging 2 to 21 days after the initial scan. Up to 20 patients will be asked to return for repeat 18F-NaF PET scan and coronary CTA imaging about 6 months after the initial scan. Researchers will compare the repeat images to the initial studies.

Eligibility Criteria:
Inclusion Criteria:

Three groups of patients will be recruited for this study.

1. Acute Coronary Syndrome group: 40 patients with type 1 myocardial infarction within 21 days prior to the imaging visit and invasive coronary angiography with angiographic evidence of at least a 50% stenosis in one or more coronary arteries. Only patients undergoing PCI will be included in the study.
2. Stable Ischemic Heart Disease group: 40 patients who have undergone invasive coronary angiography within 21 days prior to the imaging visit, with history of typical angina prior to the angiogram, but no prior myocardial infarction or coronary revascularization.
3. Asymptomatic CAD group: 40 patients who have undergone Coronary Artery Calcium scanning within 6 months prior to the imaging visit, matched to the ACS patients for age, gender, and CAC score.

   * Patients in the asymptomatic CAD group must

     * have no prior CAD associated event (no prior myocardial infarction, acute coronary syndrome, coronary angiogram, or PCI),
     * have CAC between 10 to \<1000, and
     * match to patients in the ACS group by gender, age by decile, and CAC category (using CAC categories of 10 to \<100, 100 to \<400, 400 to \<1000).

Exclusion Criteria:

* Age \< 18 years
* Creatinine \> 1.5 mg/dL
* History of severe allergy to Iodine contrast agents
* Pregnancy
* Active atrial fibrillation
* Multiple premature ventricular or atrial contractions
* Ejection fraction \<35%
* Class III congestive heart failure
Assessment Of Diabetic Maculopathy Changes After Phacoemulsification by Using Optical Coherence Tomography

Investigators aimed to assess the macular changes with OCT after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (NPDR) at the time of surgery and the effect of perioperative and postoperative topical NSAIDS on macular changes .

Diabetic patients pose a particular challenge because of the tendency for early formation of cataract in them and propensity to develop macular edema after cataract surgery. Macular edema (ME) is a major cause of vision loss after cataract surgery in patients with diabetes .

Macular edema is a common cause of unfavorable visual outcome after cataract surgery. Clinically significant cystoid macular edema (CSME) has a reported incidence of 1% to 2% after cataract surgery. Diabetes has been associated with an increased incidence of postoperative macular edema. The incidence of macular edema on optical coherence tomography (OCT) was 22% in diabetic eyes undergoing cataract surgery. The macular edema after cataract surgery in diabetic patients could be caused by the cataract surgery or diabetes itself, but it might be hard to differentiate between these two causes .

The level of the preexisting diabetic retinopathy (DR), the presence of clinically significant macular edema (CSME) before the surgery, and duration and regulation of diabetes are all important indicators of postoperative CME . Optical coherence tomography (OCT) has been established as a practical method for examining retinal architecture. OCT, with its noninvasive nature, has been proven to be an indispensable tool for diagnosing retinal pathologies, including cystoid macular edema (CME). Many studies have reported incidences of CME and macular thickness changes, determined by OCT following uneventful cataract surgeries .Nonsteroidal anti-inflammatory drugs (NSAIDS) are widely used and studied by cataract surgeons for varied benefits in the perioperative and postoperative period. Nonsteroidal anti-inflammatory drugs (NSAIDs), a class of medications that inhibit cyclooxygenase (COX) enzymes from producing pro-inflammatory prostaglandins, have multiple indications in the perioperative period including pain control, reducing inflammation, improving intraocular mydriasis, and preventing postoperative cystoid macular edema (CME) .Cataract surgeons often use NSAIDs postoperatively to control patient pain, inflammation, and prevent CME, the most prevalent complication affecting postoperative visual recovery .

Eligibility Criteria:
Inclusion Criteria:

Controlled type 2 non proliferative diabetic retinopathy (NPDR) patients. Immature cataract which does not interfere with ocular imaging.

Exclusion Criteria:

* Patient with dense cataract or vitreous hemorrhage interfering with measurement of central macular thickness Chronic uveitis Any posterior segment pathology that could affect retinal thickness Patient with complicated cataract surgery.