cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol

This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.


Eligibility Criteria:
Inclusion Criteria:

* Fasting, stable LDL-C ≥ 160 mg/dL
* Fasting, stable triglyceride \< 400 mg/dL
* BMI between 22 and 35 kg/m2, inclusive
* Females must be of non-child bearing potential
* Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion

Exclusion Criteria:

* Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
* Cancer within 5 years prior to screening
* History of congestive heart failure or chronic heart failure
* Uncontrolled cardiac arrhythmias
* History of coronary heart disease
* Clinically significant abnormal baseline ECG
* History of additional risk factors for torsades de pointes
* Hepatitis B, C, or HIV positive
* Current diagnosis or known history of liver disease
* A marked baseline prolongation of QT/QTc interval
* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) \>3 x upper limit of normal (ULN) at screening
* Alanine aminotransferase, AST, GGT, or total bilirubin \>2 x ULN at screening
* Serum creatinine \> 1.5 mg/dL
* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
* Concomitant use of medications that prolongs the QT/QTc interval
* Treatment with lipid lowering therapy within 30 days prior to screening
* Use of investigational drug within 3 months prior to screening
The Effects of Dark Chocolate Implementation in Elite Athletes

Dark chocolate (DC) is rich in epicatechin which augments nitric oxide (NO) production through endothelium-dependent influences. The increased bioavailability and activity of NO have been demonstrated to statistically increase flow-mediated dilation in healthy subjects and in hypertensive patients. DC supplementation has been hailed for its positive effects on cardiovascular health and it has been proposed as a booster of physical performance in athletes, however the mechanisms by which DC improves oxidative stress, vascular function and athletic performance are not fully understood. The investigators designed a human study assessing how DC improves NO bioavailability and activity in elite athletes. Twenty-four elite soccer players (aged 18-35 years old, all males) are divided in 2 groups and randomly assigned to receive DC (85% cocoa), 40g per day or white/milk chocolate (\<35% cocoa) for 30 days. The primary outcome measure is the evaluation of Soluble NOX2-derived peptide (sNOX2-dp), a direct marker of NADPH oxidase activation. The secondary outcome measures are other markers of oxidative stress, as the soluble P-selectin (sPs), Vitamin E, soluble CD40 Ligand (sCD40L), a marker of in vivo platelet activation and flow-mediated dilation assessed by vascular ultrasound. All parameters are assessed at baseline and after 30 days in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Elite male athletes volunteers, aged between 18 and 35 years

Exclusion Criteria:

* they suffer from an allergy to cocoa or any of the ingredients contained within either of the chocolate bars
* they have a low platelet count (\< 170 x 10E09/ L)
* they are taking aspirin or aspirin-containing drugs, other anti-inflammatory drugs, or any drugs or herbal medicines known to alter platelet function or the haemostatic system in general (without a minimum washout period of one month)
* they are taking fish oils or evening primrose oil, or fat soluble vitamin supplements within the last 4 weeks
* they have unsuitable veins for blood sampling and/ or cannulation
* they have a BMI below 18 or above 35 kg/ sqm
* they are taking any medicine known to affect lipid and/or glucose metabolism
* they are suffering from alcohol or any other substance abuse or are having eating disorders
* they have any known clinical signs of diabetes, hypertension, renal, hepatic, hematological disease, gastrointestinal disorders, endocrine disorders, coronary heart disease, infection or cance
New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System

Evidence exists that the activation of actions activates the same cortical motor areas that are involved in the performance of the observed actions. The neural substrate for this phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a basic role in understanding the intentions of others and in imitation learning. There is evidence that action observation has a positive effect on rehabilitation of motor disorders after stroke. The aim of this study is to demonstrate that action observation followed by the repetition of the actions previously observed has a positive impact on rehabilitation of the upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In particular, the purpose is to assess if mirror neurons could improve the amount, the quality and the velocity of movements and the cooperation between the two upper extremities.


Eligibility Criteria:
Inclusion Criteria:

* children with hemiplegia and
* Melbourne assessment \> 50 points

Exclusion Criteria:

* inability to collaborate
* pharmacoresistant epilepsy
* inability to imitate gestures
* sensitivity disorders
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes

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

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

Eligibility Criteria:
Inclusion Criteria:

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

Exclusion Criteria:

* Eyes with follow-up less than a year
Efficacy of SM on Postural Instability and Quality of Life in Patients With Chronic Non Specific Low Back Pain(CNSLBP)

This study will give a new insight to the physiotherapy fraternity in the effects of spinal manipulation in as clinical practice, as well as the patient's community in quick re-establishment of functional ability, pain decrease, and improvement of quality of life for economic reasons. In this high opinion, application of short-term intensive spinal manipulation for non specific chronic low back pain treatment is desirable.

The protocol for group A included High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae.The HVLA thrust will be performed with the patient side lying in a neutral.52 They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.

The protocol for group B included sets of exercise therapy. There are three components to the exercise therapy (ET) program: self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's manage their LBP and prevent future LBP recurrences. Total number of visits 12 (e.g., ability to perform exercises independently).

Outcome:

Patient self-report outcomes will be collected at first baseline visit and its base on the pain intensity and quality of life will be assessed by using numerical pain rating scale and EuroQol questionnaire. Objective outcome measures will be collected at the first baseline visit and its base on postural instability and pressure pain threshold will be assessed by using Win track platform and digital algometer.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years of age.
* Both genders.
* Subjects diagnosed with non-specific chronic low back pain with duration of \>3 months.
* Low back pain intensity≥3 on 0-10 in numerical pain rating scale.

Exclusion Criteria:

* Injury or surgery of spine.
* Congenital spinal deformity (e.g Spina bifida, Scoliosis, ankylosing spondylitis etc )
* Lumbar radiculopathy or presenting neurological deficit.
* Subjects administered Epidural injection.
* Contra-indication to manipulations-vertebral malignancy, vertebral-basilar insufficiency, bone infections, fracture.
Periodontal Assessment of a Bariatric Care Population

Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients.

Our secondary objectives are to:

Investigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients.

Investigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population.

Investigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.

Overall design and plan of the study This is a cross-sectional association study. The study population will be recruited among individuals attending the UCLH Centre for Weight Loss, Metabolic \& Endocrine Surgery (UCLH bariatric clinic) and have given written informed consent to the study.

Experimental Design All individuals who consent to this study will receive as part of their routine care a medical examination, where a series of parameters are recorded (including age, gender, smoking status, Bio-impedance for full body composition, ethnicity, and body mass index). These data will be copied for this study. A blood sample will also be collected for genetic analysis unless the patients have DNA already collected and it has been verified that the results are available. In that case no venepuncture will be needed.

All subjects will receive a basic periodontal examination (BPE). For individuals with signs of destructive periodontitis (BPE scores 3-4) full mouth plaque and gingival bleeding scores will also be calculated. In addition to that also a comprehensive full mouth periodontal probing depths assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to be enrolled in the study:

1. Subject must be over 18 years of age.
2. Subject must have a BMI of higher or equal to 30 kg/ m2
3. Subject must have voluntarily given written informed consent.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:

1. Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications.
2. Self-reported pregnancy.
3. Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.
4. Subject knowingly has HIV or Viral Hepatitis.
5. Patients are completely edentulous.
6. Subject with uncontrolled systemic illnesses.
7. Subject is not capable to give informed consent.
8. Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).
Comparing Skin Conductance and Nol-index

Comparison of twà different nociception monitors during general anesthesia

Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).

Eligibility Criteria:
Inclusion Criteria:

* moderate-to-high risk cardiac or vascular surgery
* ASA 2-4

Exclusion Criteria:

* chronic arrhythmia (e.g. atrial fibrillation)
* aortic insufficiency
* pacemaker
* implanted defibrillator
* valve surgery
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy

The purpose of this study is to compare whether epidural analgesia would provide equal analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.

Thoracotomy is an invasive surgical procedure, which is mainly performed in patients with pre-existing lung disease such as lung cancer or chronic obstructive pulmonary disease. Pain after thoracotomy is considered the most intense acute postoperative pain, adversely affecting the ability to cough, deep breathing, and lung function, resulting in respiratory complications and delayed recovery. The adverse effects can be further aggravated by occurrence of chronic post-thoracotomy pain.

Thoracic epidural analgesia is often recommended as the gold standard for the relief of acute post-thoracotomy pain. Thoracic paravertebral blockade or intrathecal opioid analgesia has also been shown to be efficacious for pain relief. Since there is no ideal single regional technique for pain relief after thoracotomy an alternative method maybe the combination of low-dose intrathecal morphine and sufentanil plus continuous thoracic paravertebral analgesia with local anesthetics.

We therefore hypothesized that combining intrathecal sufentanil and morphine with thoracic paravertebral applicated ropivacaine would provide equal analgesia compared to thoracic epidural analgesia with ropivacaine and sufentanil. We further speculate that this new regimen would have a lower incidence of typical side effects due to TEA, such as block failure, hypotension or urinary retention.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male/female
* Age: 18 - 75 years
* Informed consent of the patient
* Elective thoracotomy
* Two chest drains

Exclusion Criteria:

* Contraindications against the use of regional techniques: known allergy to local anesthetics
* Infection around the puncture site
* Coagulation disorders
* Drug abuse
* Emergency surgery
* Pregnancy
Patient-Centered Alternative to Psychiatric Hospitalization for Veterans

A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans.

Background:

A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans.

Objectives:

The study tested the hypotheses that veterans treated in a START program would demonstrate greater improvement in symptoms and quality of life, as well as greater satisfaction with treatment and lower costs of care than veterans treated at the VA inpatient unit.

Methods:

This study includes elements of both efficacy and effectiveness studies. VA psychiatric unit treatment and START are compared in a randomized trial, with follow up of subjects at 2, 6, and 12 months as they experience real-world treatment-as-usual. Symptoms, functioning, quality of life, and satisfaction with services are assessed on multiple standardized measures, as well as by qualitative assessments.

Status:

Final report is under preparation.

Eligibility Criteria:
Inclusion Criteria:

Have to a veteran and in need of acute hospitalization, but able to take care of themselves. (Max Age is 59)

Exclusion Criteria:
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study

This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.

This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Presenting at initial (approximately 2-week) postoperative follow-up
* Prior management of isolated fracture or multi-trauma

Exclusion Criteria:

* Incarceration
* Problems, in the judgement of study personnel, with maintaining follow-up
* Cognitive disability (either acute or chronic)
Weaning And Variability Evaluation

Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation for \>48 hours,
* patient is ready for SBTs for assessment for extubation,
* has a normal sinus rhythm at time of SBT (no pacemaker),
* is tolerating pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O),
* hemodynamically stable (low or no vasopressors), stable neurological status (no deterioration in GCS during prior 24 hours \& ICP \< 20),
* intact airway reflexes (cough \& gag).

Exclusion Criteria:

* Order not to re-intubate,
* anticipated withdrawal of life support,
* known or suspected severe weakness (myopathy, neuropathy or quadriplegia),
* tracheostomy,
* and prior extubation during ICU stay.
Prospective Analysis of "genotype-phenotype" Correlations Observed in a Large Cohort of Patients with Hereditary Retinal Dystrophies - GEPHIRD

This study will carry out a detailed descriptive analysis of a large population of patients with hereditary retinal dystrophies (HRD): clinical, paraclinical and genetic data.

The information drawn from these analyzes will provide a better understanding of the pathophysiology of these rare diseases and this may ultimately impact the medical management of patients (targeted therapy).


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for suspicion of hereditary retinal dystrophy
* Benefiting as part of the care of a genetic analysis

Exclusion Criteria:

- Patient under a measure of legal protection
Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

This study aims to better understand the behavioral, neurobiological and hormonal underpinnings of stress and reward reactivity of adolescents suffering from borderline personality disorder compared to healthy adolescents by a multimodal approach based on clinical assessments, structural and functional mri and experimental acute stress exposure.

Borderline Personality Disorder (BPD) is a severe condition associated with intense emotional and behavioral responses to stressful events, impulsivity, and risk-taking behavior. It has been shown to begin in adolescence. However, very few studies have addressed the physiopathology of BPD in adolescents. In order to gather rational information for targeted care, the heterogeneity of BPD determinants needs to be disentangled. To this aim, a multimodal approach to BPD dimensional aspects is proposed.

BPD adolescents will be compared to typically developing controls in two complementary experimental designs: (1) Monitoring of neurovegetative, hormonal and body motion responses to an acute stress, with the hypothesis that stress reactivity might account for the physiopathology of the disorder; (2) Structural and functional imaging (fMRI BOLD) in the context of a reward processing task to delineate the neural/functional basis of BPD risk taking behavior.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent subject: 13 years ≤ age ≤ 18years
* Affiliation to social welfare
* Informed consent to participate in the protocol, consent signed by the major subject or by one of the legal guardians if the subject is a minor
* Diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and Abbreviated- Diagnostic Interview of Borderline Personality Disorder (Ab-DIB)
* Somatic and intellectual state compatible with blood sampling and MRI examination

Exclusion Criteria:

* Non-affiliation to social welfare
* Refusal to give consent and / or to sign informed consent by the subject or his or her legal guardian if the subject is a minor
* Somatic pathology in progress, or pregnancy (urine test of pregnancy in case of doubt)
* Contraindication to magnetic resonance imaging:
* Presence of a ferromagnetic foreign body
* Subject carrying a pacemaker
* Subject carrying ventricular bypass valves
* Claustrophobic topic
* Subject suffering from the following diseases:
* Intellectual impairment Intellectual Quotient (IQ) \<70,
* Claustrophobia,
* Obsessive Compulsive Disorder,
* Tic Disorder,
* Autism Spectrum Disorder,
* Attention Deficit Disorder with or without Hyperactivity,
* Bipolar disorder,
* Schizophrenia