cyrilzakka/clinical-trials huggingface dataset:
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation

1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* persistent/permanent atrial fibrillation
* good acoustic apical window
* left ventricular ejection fraction \> 50%
* pulmonary artery systolic pressure\< 50 mm Hg
* no more than mild mitral or aortic valve disease
* ability to attend clinical and echocardiographic follow-ups
* signature of the study informed consent

Exclusion Criteria:

* pregnancy
* implanted pace-maker or ICD
* previous heart valve surgery or transcatheter treatment
* previous heart transplant
* organic tricuspid regurgitation
Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)

CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.


Eligibility Criteria:
Inclusion Criteria:

1. Presenting (in person or via telemedicine) for evaluation because they:

   * Have clinical symptoms consistent with for COVID-19:
   * Fever (≥ 37.8 °C) on examination OR patient reported fever (≥ 37.8 °C) or feverishness (felt febrile but did not take temperature) OR any of, cough, sore throat, shortness of breath, rhinorrhoea, headache, chills, generalise myalgia, malaise, fatigue, confusion, diarrhea, nausea or vomiting
   * Have been contacted because they have been identified as a contact to a confirmed case
   * Have been contacted and told they tested positive for COVID-19
2. Have one of the following conditions affecting immune function:

   * Known or suspected primary immunodeficiency, defined as a predisposition to infection associated with an apparent or presumed deficit of immune function
   * On immunosuppressive therapy
   * Treatment with immune checkpoint inhibitors within 36 months of enrolment date
   * HIV infection
   * Diagnosis of cancer within 36 months of enrolment date, excluding superficial basal cell and squamous cell carcinomas
   * Solid organ transplantation
3. For optional biobanking only, ability to provide informed consent

Exclusion Criteria:

* Nil
PRotEin Provision in Critical IllneSs

Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function.

The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.

ICU-acquired weakness (ICU-AW) is frequent among ICU survivors and negatively affects both short and long term outcomes. ICU-AW is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of ICU admission.Therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after ICU discharge are urgently needed.

Retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. Current ICU guidelines recommend dietary protein delivery at 1.3 g/kg/day (ESPEN), or even up to 2.0 g/kg/day (ASPEN). However, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. Therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients.

The focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. Previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. Therefore, it is nowadays increasingly recognized to move primary ICU trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or above) patient admitted to the ICU
* Unplanned ICU admission
* Invasive mechanical ventilation initiated \<24 hours of ICU admission
* Expected ICU stay on ventilator support of 3 days or more

Exclusion Criteria:

* Contraindication for enteral nutrition
* Moribund or expected withholding of treatment
* Kidney failure AND 'no-dialysis'-code on admission
* Hepatic encephalopathy.(West Haven grade 3 or 4)
* Body-mass index \< 18 kg/m2
A-mode vs PalmScan Ultrasonography: Biometric Measurements.

Ultrasonography has become a critical ancillary test in the clinical practice of ophthalmology. It is commonly used as a standardized method for assessing intraocular biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same principles as the standard A-scan. The aim of the study is to compare the reliability of their measurements, in order to use them indistinctively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for a standard A-mode ultrasound

Exclusion Criteria:

* No superficial anormalities.
* Patients with external injuries.
* Intraocular silicon oil.
* Retinal detachment
* Significant ocular pathologies.
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with confirmed advanced breast cancer.
* Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
* Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

* Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
* Patients who have had prior chemotherapy for advanced breast cancer.
* Patients of child-bearing potential who are unwilling to use contraception.
Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain

Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.

The first phase of the study was a randomized controlled study. In the second phase, all subjects will receive fascia iliaca, lateral femoral cutaneous, or femoral nerve blocks based on the proposed donor site location and will be compared to historic controls from the first phase. In the first phase, the control group underwent split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. In the first phase, the experimental group underwent injection of liposomal bupivacaine (Exparel) at the time of harvest of the skin graft. In the second phase, patients will undergo preoperative regional anesthesia with a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location rather than the standard protocol of lidocaine with epinephrine at the donor site. Thus, in the second phase, group 3 (preoperative block group) will be compared to historic controls which received the standard of care in the first phase of this trial. Baseline pain levels will be obtained for all subjects using a validated pain assessment scale, the Visual Analog Pain Scale. Postoperatively, time to first opioid pain medication (excluding immediate postoperative recovery from anesthesia), total opioid consumption on a daily basis, and donor site interval pain scores using a validated pain assessment scale will be obtained. The experimental groups will then be individually compared to the control group to determine if there is a significant difference in pain levels, time to first opioid, and overall opioid consumption between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Spanish/English speaking
* \<20%TBSA; \<5% TBSA deep partial or full thickness burns

Exclusion Criteria:

* chronic pain syndrome
* \> 20% TBSA burn injury; \> 5% TBSA deep partial or full thickness burn
* pregnant
* allergy to lidocaine or other local anesthetics
* burns to anterior thighs
Bingo Drug-eluting Balloon in Bifurcation

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female ages 18-80 years old
2. Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
3. Patients with bifurcation lesions of coronary artery observed by angiography.
4. The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation.
5. De Novo bifurcation lesions and diameter stenosis are not less than70%;
6. Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
7. Residual stenosis are not more than 50% after predilatation;
8. Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion Criteria:

1. Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
2. Left main coronary artery lesions without protection or related bifurcation lesions
3. Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
4. Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl；
5. Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;
6. Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor)
7. Patients whose expected lives are less than 1 year;
8. Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
9. In-stent restenosis lesions
10. Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.
Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging

Much of human interaction is based on trust. Aging has been associated with deficits in trust-related decision making, likely further exacerbated in age-associated neurodegenerative disease (Alzheimer's disease/AD), possibly underlying the dramatically growing public health problem of elder fraud. Optimal trust-related decision making and avoiding exploitation require the ability to learn about the trustworthiness of social partners across multiple interactions, but the role that learning plays in determining age deficits in trust decisions is currently unknown.

Aim: Probe the malleability of the underlying neurocircuitry of trust-learning deficits in aging. This study will utilize real-time fMRI neurofeedback to train older adults in brain activity up-regulation toward enhanced trust-related learning in aging and confirm critical mechanisms of experience-dependent social decisions in aging.

Grant R01AG072658 Aim 3: Test the malleability of trust-learning neurocircuitry toward optimized trust-related decision making in aging.

This study will apply rtfMRI neurofeedback training as an intervention method, to demonstrate that older adults can be trained in volitional brain activity up-regulation, reducing their trust-learning deficits. The study will comprises several MRI sessions including pre-training, training, and post-training scans.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide verbal and written informed consent
* Fluent English speaker
* At least 8th grade education
* On stable medication regimen

Exclusion Criteria:

* Pregnancy
* Magnetic resonance imaging contraindications (e.g., certain metallic objects in body, claustrophobia)
* Current major depression defined as scores \>14 on the Beck Depression Inventory-II
* Impaired scores on the Telephone Interview for Cognitive Status (TICS; cut-off of \>30)
* Current use of medications with significant anticholinergic properties due to potential influence on memory ("memory enhancing"; e.g., Aricept or Namenda)
* Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
* Uncorrected visual and hearing impairments
* Neurologic conditions affecting the brain (e.g., severe stroke, epilepsy, traumatic brain injury with \>30-minute loss of consciousness)
* Impaired scores on a cognitive screening measure, the Montreal Cognitive Assessment (MoCA); for older adults the cutoff will be age and education corrected
* Unstable medical illness (e.g., metastatic cancer)
* Significant cardiovascular conditions (e.g., major heart attack)
* Will not exclude participants who are taking anti-depressant medications. Use of antidepressants (particularly SSRI's) and anxiolytic medications will be recorded and included in post-hoc analyses
Craniosacral Therapy to Treat Chronic Low Back Pain

The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.

Design: Randomized clinical trial. Objective: to determine the effectiveness of a craniosacral therapy program on disability, quality of life, autonomic nervous system, body mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients with chronic low back pain.

Participants: Seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group.

Intervention: For 10-week, the experimental group will undergo treatment comprising 10 sessions (1/week) of a craniosacral therapy program with ten techniques, and the control group will receive only one craniosacral technique.

Main Outcome Measures: disability, quality of life, biochemical estimation interstitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain for \> 3 months
* Score \> 4 on the Roland Morris Disability questionnaire
* No undergoing another physical therapy treatment

Exclusion Criteria:

* Clinical signs of radiculopathy
* Presence of lumbar stenosis
* Fibromyalgia
* Spondylolisthesis
* History of spinal surgery
* Treatment with corticosteroids in the past two weeks
* Disease of the central or peripheral nervous system
Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)

This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study

Principal objective: To define the therapeutic effect of Vitamin D in the chronic maintenance treatment of COPD by means of a prospective randomized placebo-controlled double blind study of 182 patients with a follow-up of at least one year. Primary endpoint is the median time to next exacerbation. Secondary endpoints are total number of exacerbations per group, number of exacerbations per patient per year, percentage of patients with one or more exacerbations per year, days of antibiotics and oral steroids, quality of life, FEV1, muscle force and survival.

Other objectives: First, to investigate the role of local and systemic levels of 25-OHD and 1,25-(OH)2D on the intensity and prevalence of bacterial colonisation, inflammatory markers, proteases and markers of oxidative stress in induced sputa and exhaled air. Second, to explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the VDR-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of COPD exacerbation
* Smoking history of at least ten pack years
* GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry
* Informed consent

Exclusion Criteria:

* Tiffeneau index \>70% or FEV1 \>80%
* Hypercalcemia
* Sarcoidosis
* Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
* Active cancer
Neuron Specific Enolase in Ventricular Assist Device Recipients

An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Patients eligible for left ventricular assist device (LVAD) typically have severe heart failure, which is characterized by poor cardiac output. The relatively abrupt increase in cardiac output that follows implant of a LVAD may cause reperfusion injury. Furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. Neuron specific enolase (NSE) has been established as a biomarker of reperfusion injury. We hypothesize that changes in NSE following LVAD will be greater than the changes in NSE noted in a control population of patients undergoing non-VAD cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

Group 1 - Pre-VAD implantation patients

* 18 years and older
* lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group
* 18 years or older
* Planning to undergo valve or coronary bypass surgery

Exclusion Criteria:

* Acute cerebrovascular infarction
Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Males and nonpregnant females at least 18 years of age, with DME in the study eye
* Edema must involve fixation and be at least 1 disc area in size
* Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
* The study eye must have received at least one macular laser treatment \> 12 weeks prior to entry into the study
* Ability and willingness to comply with treatment and follow-up
* Ability to understand and sign the Informed Consent form

Exclusion Criteria:

* Pregnant, lactating females
* Allergy to fluocinolone acetonide or any component of the delivery system
* Any disease or condition that would preclude study treatment or follow up
* Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
* History of uncontrolled IOP within the last 12 months
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA

From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.

The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).

The study will not present a control group or comparison groups between therapeutic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 15 years at the time of surgery
* Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
* Minimum follow-up of 5 years

Exclusion Criteria:

* Revisions/explantation of the endorthesis device
* Patients with active acute or chronic infections
* Patients with chronic inflammatory joint diseases
* Patients with previous significant trauma of the lower limbs following surgery
* Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
* Patients with cognitive deficits
* - Patients with concomitant neurological pathologies
* Patients suffering from tumor pathology
* Patients with cardiac pacemakers or other prostheses equipped with electronic circuits
* Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures
* Patients with orthopedic metal prostheses
* Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material
* Pregnant patients
* Patients with insulin pumps and non-removable contact lenses