cyrilzakka/clinical-trials huggingface dataset:
Inflammatory Biomarkers in Psychogenic Non-epileptic Seizure

1. Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure.
2. Possible role to predict the prognosis of patients with epileptic seizure.

Epilepsy is one of the most prevalent neurological disorders characterized by frequent somatic and psychiatric co-morbidities(1). Accurate diagnosis of epilepsy is challenging because clinicians rarely observe the actual clinical seizure outside of the hospital. Furthermore, psychogenic nonepileptic seizures (PNES) can mimic epileptic seizures (ES), leading to erroneous diagnosis and inappropriate treatments. A critical gap in the diagnostic assessment of seizures is a blood test that can distinguish ES from PNES (2). Both diagnoses were confirmed by the gold standard diagnostic method video/electroencephalogram (EEG) monitoring (3). Taking all in to account, the notion that neuro-inflammation is the key pathology behind focal epileptic seizure initiation and maintenance and the dynamic and adaptative process of neuro -inflammation is associated with blood-brain-barrier disruption and glial activation is no longer a surprise (4).

Tumor necrosis factor related apoptosis inducing ligand (TRAIL) regulates immune responses via apoptosis, with lower levels associated with severe infection, including sepsis (5). Monocyte chemoattractant protein-2 (MCP-2) has been well recognized to participate in immune regulation via binding to chemokine receptors and activation chemotaxis in lymphocytes T, natural killer (NK) cells, and monocytes therefore contributing to the pathogenesis of monocyte-dependent tissue injury (6). Hence, MCP-2 overexpression could result in an increased immune response. Further, since increased levels of MCP-2 have been observed in patients with Alzheimer's disease, this may further support the existence of the biodirections relationship between neurodegeneration and seizures/epilepsy (7).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as epileptic seizure are aged \>12 years patients diagnosed as psychogenic non-epileptic seizure are aged \>12 years Normal healthy control for comparison. Heathy control are aged \>12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw

Exclusion Criteria:

* Neurological criteria: Other CNS disorders including Parkinson's disease, amyotrophic lateral sclerosis ,cerebrovascular stroke, Psychiatric disorders {major depression disorder , generalized anxiety, mania and other psychiatric diseases).

Others: Tumors and cardiovascular
Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female patients minimum 18 years of age
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
3. Target lesions treatable with 4mm stent (visual estimate);
4. Target lesion is 30mm in length (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
3. Documented Left ventricular ejection fraction 25%;
4. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.

The present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of MyopiaX in slowing the progression of myopia.

The trial consists of 12 months treatment period. The first 6 months participants will be treated either with MyopiaX or with myopia control spectacles. During the second half of the trial, participants treated with MyopiaX will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 ratio to either the MyopiaX or the myopia control spectacles group.

Eligibility Criteria:
Inclusion Criteria:

* Myopic children (-0.75 to -5.0 D SER, least myopic meridian -0.50 D in each eye)
* At least VA 0.2 LogMAR in each eye
* Age: 6 - 12 years old
* Good tolerability of test session with VR system
* Binocular adequacy as tested with VR
* Ability to understand treatment and give valid assent

Exclusion Criteria:

* Concomitant or previous therapies for myopia
* Eye diseases/conditions:
* Anisometropia ≥ 1.5 D
* Astigmatism ≥ 3 D
* Ophthalmological comorbidities
* Optic nerve abnormalities
* Suspicion of syndromic or monogenetic myopia
* Systemic illnesses affecting eye health, eye growth, and/or refraction
* Any illnesses affecting dopamine function (e.g., sleep disorder)
* Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications)
* Participation in other clinical studies
* Medical history (or family history) of photosensitive epilepsy
Bioelectrical Impedance Spectroscopy in Heart Transplantation: Tracking Post-Transplant Changes in Body Composition and Correlation With Conventional Preoperative Risk Assessment Modalities

Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be regarded as unsuitable candidates for advanced cardiac replacement therapies. However, little data exist on precisely which measures are predictive of subsequent adverse events. Assessment of nutritional status and frailty is still largely predicated on crude and obsolete parameters, such as baseline serum albumin level or body mass index (BMI). In this prospective cohort study the investigators will evaluate the use of bio-electrical impedance spectroscopy (BIS) as a measure of body composition and assess the associations with surgical outcomes.

This is a prospective cohort study, with study visits at Enrollment and subsequently at ≤10 days , 1 month (+/- 7 days), 3 months (+/- 7 days) , 6 months (+/- 14 days) , and 12 months (+/- 14 days) after heart transplant surgery.

BIS measurements will be performed on patients both in the pretransplant and post-transplant periods except when contraindicated in the pretransplant setting concerning patients with advanced heart failure. Because the use of BIS is contraindicated in the setting of permanent pacemaker and/or internal cardiac defibrillator (ICD) devices, BIS assessment cannot be performed in the pretransplant setting for patients with advanced heart failure as the majority of these patients already have these devices in place. However, at the time of cardiac transplantation, these devices will be removed from those patients with advanced heart failure and the BIS measurements will then be performed shortly after transplantation, and then serially during the post-transplant period at various time intervals for one year in order to track changes in body composition.

These measurements will be compared to traditional measurements performed at the time of preoperative evaluation by the nutritional and dietitian support team.

Eligibility Criteria:
Inclusion Criteria:

* Listed for a native heart transplant at BUMC
* At least 18 years of age

Exclusion Criteria:

* Women during pregnancy
* Patient currently has a ventricular assist device
A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients

Primary Objectives:

To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.

To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.

Secondary Objectives:

To characterize the pharmacokinetic profile of SAR405838 and pimasertib.

To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.

To characterize genetic status in tumor tissue and circulating tumor DNA.

The duration of the study for an individual patient will include a period to assess eligibility of up to 4 weeks, a treatment period of at least 6 weeks of study treatment, and an end-of-study visit at least 30 days (or until the patient receives another anti-cancer therapy, whichever is shorter) following the last administration of study drug.

Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of a solid tumor.
* Presence of locally advanced or metastatic disease with at least one measurable lesion.
* Ability to provide written informed consent. Evidence of a personally signed informed consent.

Exclusion criteria:

* Age \<18 years.
* Eastern Cooperative Oncology Group performance status of \>1.
* Inadequate functions of bone marrow, liver, and kidney.
* Positive pregnancy test in women of child-bearing potential.
* Pregnancy or breast-feeding.
* Extensive prior radiotherapy.
* The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination.
* Prior history of myositis or rhabdomyolysis.
* Recent major surgery or trauma, unhealing/open wounds.
* The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study.
* The patient has a baseline corrected QT interval (QTc) \>480 ms or left ventricular ejection fraction (LVEF) \<50% or less than the lower limit of normal.
* The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations.
* Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
* Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods.
* Recent history of acute pancreatitis.
* Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Blood Flow Restricted Electrical Stimulation During Immobilisation

Following injury or surgery to a limb, it is often immobilised to allow tissue healing. Short periods of disuse cause loss of muscle size and strength and impaired mechanical properties of tendons, which leads to reduced function. Strategies to combat these deconditioning adaptations include neuromuscular electrical stimulation (NMES), however at present its effectiveness is limited. Recent research suggests that the effects of NMES can be augmented with blood flow restriction (BFR). At present, the effect of combining these two techniques on muscle function during limb immobilisation is unknown. Furthermore, the impact of BFR training during retraining following immobilisation is unknown.

Following injury or surgery to a limb, it is often immobilised to allow tissue healing. Short periods of disuse cause loss of muscle size and strength and impaired mechanical properties of tendons, which leads to reduced function. Strategies to combat these deconditioning adaptations include neuromuscular electrical stimulation (NMES), however at present its effectiveness is limited. Recent research suggests that the effects of NMES can be augmented with blood flow restriction (BFR). At present, the effect of combining these two techniques on muscle function during limb immobilisation is unknown. Furthermore, the impact of BFR training during retraining following immobilisation is unknown.

This study will examine the effectiveness and feasibility of a neuromuscular electrical stimulation and blood flow restriction protocol during a 7 day period of immobilisation. Multiple measures across several physiological systems will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18-55
* Non-smoker
* No previous history of cardiovascular, respiratory or neurological problems
* Not taking anticoagulant medication
* Injury-free in the 3 months prior to scheduled participation in the study.

Exclusion Criteria:

* Hypertension (\<140/80)
* Metal work in-situ
* Blood diseases or clotting issues
* Injury or previous injury (\<3 months prior to scheduled participation in the study)
* Pregnancy
Reliability and Validity of Turkish Version of PEM-CY

The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings. The aim of this study was to examine reliability and validity of Turkish version of the Participation and Environment Measure for Children and Youth (PEM-CY).

The International Classification of Functioning, Disability and Health-Child and Youth Version (ICF-CY; WHO 2007) is designed to guide assessment and intervention efforts to minimize disparities in children's participation. Participation is defined in the ICF-CY as ''involvement in life situations'' and is further conceptualized as a multidimensional construct with both objective (e.g., frequency) and subjective (e.g., satisfaction) dimensions. Participation is linked to contextual factors, including: 1) personal factors (child personal factors such as child's age, gender, and functional abilities; family demographic factors); and 2) features of environments (physical (natural and built), social, attitudinal, and institutional factors, and availability and adequacy of resources). Since its adoption in the ICF-CY, an increasing number of participation measures have been developed. Among these measures, the Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings.

Eligibility Criteria:
Inclusion Criteria:

* they will identify themselves as a parent or legal guardian of the child who is the focus of the study
* they are able to read Turkish
* their child is between 5 and 17 years old at the time of enrolment.

Exclusion Criteria:

* who don't want to attend the study
Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health

While effects of specific exercise interventions on bone and CVD in postmenopausal women have been demonstrated and evaluated, the effects of randomized controlled exercise interventions, particularly in middle-aged premenopausal women are sparse. Therefore, it is imperative to examine the relation between behavioral interventions and bone and cardiovascular outcomes in premenopausal women as this understudied group is at high risk for the initial stages of bone loss and cardiovascular disease development.

Presently, it is not clear whether the intensity of Yoga interventions is high enough to induce positive effects on bone and cardiovascular health in a healthy population. For example, Hagins et al. (2007) reported that the metabolic costs of Hatha Yoga, averaged across the entire session, represent low levels of physical activity (walking). On the other hand, Ashtanga Yoga, or power Yoga, is performed at a higher intensity than Hatha Yoga and has been shown to elicit significantly higher heart rates than either Hatha or gentle Yoga (Cowen and Adams, 2007). Sun Salutations (SS) are an example of an Ashtanga Yoga sequence, where yoga postures are performed dynamically with combinations of forward and backward bending poses (Omkar et al., 2011). A previous 8-month yoga intervention found that regular long-term Ashtanga yoga had a small positive effect on bone formation in premenopausal women. Although Yoga has the potential to be an alternative physical activity to improve bone health and arterial stiffness, there is a lack of high-quality evidence for this type of intervention. Thus, the purpose of this study is to assess the feasibility of a 12-week home-based dynamic yoga intervention designed to improve bone metabolism and arterial stiffness in healthy premenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Participants were healthy premenopausal women volunteers between the ages of 30 and 48 years.
* Participants were free of chronic back or joint problems, cardiovascular disease, non-smokers, not pregnant, not taking antihypertensive drugs or any medication that affects bone density.
* Participants didn't have regularly participated in a weight training program and yoga exercise at least 12 months prior to the study.
* Participants were medically stable, ambulatory, and capable of training.

Exclusion Criteria:

* Individual who were outside of the 30-48 years age range and who exceed the weight limit of the DXA (300 pounds).
* Individuals who did not have the regular menstrual cycles.
* Pregnancy or the possibility of becoming pregnant during the intervention period
* Individuals who were taking medications known to affect bone metabolism such as steroid hormones, calcitonin, or corticosteroids.
* Any persons with physical and mental disabilities preventing them from being trained, including orthopedic or arthritic problems, were not allowed to participate.
* Individuals whose radiation exposure from medical and/or research tests in the previous year exceeds the recommended regulator limit.
Healthy Relationships and Economic Pathways

The California Adolescent Health Collaborative (CAHC) brings together multiple nonprofit organizations in California's Central Valley to implement the Healthy Relationships and Economic Pathways (H-REP) program, which aims to increase and promote healthy relationships and stability among youth between the ages of 14 and 24.

This research project was designed to explore three core questions (RQs).

Research Question 1:Does assignment to the HRE improve the knowledge and skills necessary to develop and maintain caring and supportive personal and professional relationships among youth between the ages of 18 and 24 in Stanislaus and Merced Counties?

In addition, American Institutes for Research (AIR), an independent evaluator, has been asked to answer two supplemental RQs:

Research Question 2: Does participation in the HRE Technology Boot Camp improve technological knowledge and skills as well as awareness of professional and educational opportunities among youth between the ages of 18 and 24?

Research Question 3: Does HRE have the same effect on relationship knowledge and skills for youth between the ages of 18 and 24 who participate in the HRE-only training as it does for youth who participate in HRE plus Technology Bootcamp?

H-REP provides a comprehensive, three-pathway program of services to (a) students in traditional, comprehensive high schools; (b) students in continuation of alternative schools (e.g. court schools); and (c) youth between the ages of 18 and 24 who are receiving employment support services from Central Valley nonprofit programs. The H-REP program involves formal classes in Healthy Relationship Education (HRE) and technology use, case management, and job skills training.

Eligibility Criteria:
Inclusion Criteria:

* students in traditional, comprehensive high schools; students in continuation or alternative schools; youth between ages of 18-24 who receive employment support services from Central Valley non-profit programs (California); residents of Merced or Stanislaus counties (California).

Exclusion Criteria:

* less than sixth-grade English language proficiency
Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer

The occurrence of dysphagia is a well-known early feature of esophageal cancer that may reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in patients with esophageal cancer before and after surgery is not well known and its possible consequences have been debated.

Aim: The aim of this study was to prospectively explore body composition and function in a cohort of patients with esophageal cancer before and after surgery with curative intent. In particular, to investigate the prevalence and development of sarcopenia and body composition as a consequence to surgery for esophageal cancer and the possible relation to morbidity, length of stay and quality of life (QoL).

Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for surgery with a curative intent, data on body-composition measured with bioimpedance, working capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were prospectively collected. Data regarding dysphagia was derived from an esophagus related quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length of stay and preoperative weight loss were collected from medical charts.


Eligibility Criteria:
Inclusion Criteria:

* Cancer of the gastro-esophageal junction or the esophagus.
* Planned for curative surgery.
* Informed consent

Exclusion Criteria:

* Not fulfilling the above.
* Patient declined participation.