cyrilzakka/clinical-trials huggingface dataset:
Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

Iodine is one of essential micronutrient for human, both iodine deficiency and excess will be harmful for human health. Children is the susceptible population to iodine nutrition, and studies show that even mild iodine deficiency would affect the growth and development of children, so it is urgent to identify the dietary recommended nutrient intake (RNI) of iodine for children to guide children scientifically and safely supplement iodine. There are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

Based on the investigators'previous study on upper safe level of iodine on children from areas with high iodine in drinking water, this study will conduct an epidemiological study on 600 children living in areas with high water iodine content but the actual iodine content in participants' drinking water is not so high, while no supply of iodized salt.

Meanwhile, in order to get iodine dietary recommended nutrient intake (RNI) values of children. The investigators will conduct a iodine balance experiment on children with sufficient iodine nutrition. We will randomly select thirty healthy students for a three-day iodine balance experiment from the cross-sectional study. The investigators will use the regression model to obtain an iodine intake value when children at"zero iodine"balance. Combine the study at population and individual level, the investigators will obtain data on dietary recommended nutrient intake (RNI) of iodine for Chinese children, to properly guide children iodine supplementation to avoid iodine deficiency, which also will provide data for the update of Chinese dietary reference intakes of iodine.

Eligibility Criteria:
Inclusion Criteria:

Normal body mass index and thyroid function have not been treated for thyroid disease have not used amiodarone and other drugs (including iodine supplements) during the investigation have no major diseases and family history have lived in the local area for more than 5 years

Exclusion Criteria:

Long-term low-protein long-term low-heat energy malnutrition
tDCS Effects on Chronic Low Back Pain

Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back pain. Up to date clinical research studies have shown that transcranial direct current stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain and facilitating the mechanisms inhibitors descendants of pain control.

The aim of this study is to test the feasibility of combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back pain.

Chronic low back pain involves high individual and social costs. Back School (BS) is a behavioural intervention designed to treat and prevent the aforementioned condition. Up to date clinical research studies have shown that transcranial direct current stimulation (tDCS) can be considered a reliable tool for chronic pain. It has been shown how tDCS is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain, such as the thalamus, and facilitating the mechanisms inhibitors descendants of pain control. The aim of this study is to test the feasibility of combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back pain. Specifically, we will test their effects on low back pain intensity and participation of patients' in daily activities.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged \> 18 years and \<75 years
* presence of non-specific chronic low back pain diagnosed \> 2 years
* presence of a chronic pain measurable with the VAS scale not less than 3 during a 2 weeks daily VAS monitoring
* pain refractory to drugs (opioid analgesics, tricyclic antidepressants, antiepileptic drugs). It is considered a refractory pain if there is at least 6 months of treatment with at least 2/3 of the above drugs

Exclusion Criteria:

* spine surgery
* cognitive impairment assessed with Mini Mental Status Examination \<24
* contraindications to tDCS: presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
* Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
* Neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* Pregnancy
Static Balance in Children With Autism vs. Neurotypical Peers

The Virtual Reality Rehabilitation System (VRRS) is an innovative and sophisticated technology, aimed to generate immersive and interactive settings intended for therapeutic and evaluative objectives. Through the utilization of virtual reality technology, it constructs diverse scenarios, tasks, and activities in a controlled digital environment, fostering engagement. Primarily crafted for rehabilitation purposes, the VRRS features adaptable programs addressing various therapeutic requirements, encompassing motor skill enhancement, cognitive challenges, and assessments related to balance.Understanding the nuanced motor abilities in children, particularly those with neurodevelopmental conditions like autism, is a critical area of research in pediatric rehabilitation. The significance of this research lies in comprehending the specific balance challenges experienced by children with autism spectrum disorder (ASD), a population often noted for motor coordination and balance difficulties. Because VRRS offers a controlled and engaging environment, this study seeks to provide a detailed analysis of static balance abilities in capabilities in children diagnosed with ASD in comparison to typically developing (TD) children. The study also wants to explore the efficacy of VRRS as an assessment tool for pediatric balance evaluations.The primary objective of this study is to highlight the distinctions in postural control between ASD and TD children, utilizing an objective quantification tool to delineate the differences between the two groups. This will be achieved through a group comparison study involving two distinct cohorts. The first group will comprise 30 school-aged children with ASD, while the second group will consist of 30 TD school-aged children. To evaluate postural control, both groups will participate in an activity utilizing the VRRS in conjunction with a stabilometric balance platform. During the assessment task, participants will stand on the balance platform with their eyes open, focusing on a fixed point displayed on the VRRS screen for a duration of one minute. This process will be repeated three times for each participant. The combined use of VRRS and the stabilometric balance platform aims to provide a comprehensive evaluation of postural control abilities in both groups, allowing for the observation and measurement of potential differences in stability and balance performance between children with ASD and their neurotypical counterparts.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism; QI ≥ 75

Exclusion Criteria:

* Motor deficits due to another clinical condition
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)

The purpose of the present study is to determine whether the use of an abdominal binder is effective in the non-pharmacological management of orthostatic hypotension in patients suffering from Parkinson's disease

In the present single blinded cross-over trial we investigated the effects of an elastic abdominal binder on blood pressure changes (systolic, diastolic and mean blood pressure) after 3 minutes of head-up tilt test in patients with Parkinson's disease and orthostatic hypotension.

Secondarily, we investigated the effects of an elastic abdominal binder on symptoms of orthostatic hypotension in daily living in a 4-weeks open-label follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD
* Hoehn \& Yahr stadium \< or = 4
* Age: 40-90
* Laboratory confirmed neurogenic orthostatic hypotension (NOH)
* Stable pharmacological therapy in the last 6 weeks
* Full legal competence

Exclusion Criteria:

* Other major neurologic or psychiatric diseases
* Untreated diabetes mellitus with clinical features of peripheral neuropathy
* Major cardiac diseases (ischemic, structural, arrhythmias)
* Evidence of varices (venous insufficiency stage \> or = C2, "varicose veins")
* Known or suspected pregnancy
* Breast feeding
Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease

Background: Studies about the effects of walking training with additional body load in Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during treadmill walking improves reflex activity and leg extensor muscle activity, which are impaired in subjects with PD.

Purpose: The purpose of this study was to assess the effects of treadmill walking training with additional body load on the ground reaction forces, spatiotemporal, and kinematic variables of the gait of subjects with moderate PD.

Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were conducted in a movement analysis laboratory, and at the rehabilitation unit of the University, respectively.

Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.

Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10% increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.

Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic variables during overground walking, at baseline and after each phase.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD (previously diagnosed by one specialist physician,)
* Hoehn and Yahr (H-Y) stages 2 through 3,
* Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level) and,
* Capacity to ambulate independently for at least 10 meters.

Exclusion Criteria:

* Change medication (dopaminergic) during the study period,
* Use treadmill for at least six months prior to the study, and
* Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the performance of the training.
Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading

There is gender dimorphism in cardiovascular risk, with men at higher risk than women. However, the fundamental basis for the protective effect of female sex remains unclear. Recent data implicate the natriuretic peptide (NP) system as an important determinant of blood pressure. Also, NP levels are twice as high in women of reproductive age than in men, and gonadal steroids are important determinants of circulating NPs. These are the marked, but poorly understood differences in the NP status between men and women. The investigators hypothesize that gonadal steroids regulate NP release, specifically that testosterone inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading. Understanding the basis for gender differences in NP function should provide important insights regarding mechanisms underlying hypertension in men versus women.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* no history of hypertension
* normal BMI
* Male: normal testosterone and free testosterone levels
* Female: regular menses, negative pregnancy test, no sex steroid therapy \>/=3 mos

Exclusion Criteria:

* on hypertensives, diuretics, or insulin
* with diabetes mellitus
* estimated creatinine clearance \<60 ml/min
* prior cardiovascular, liver or renal disease
* history of hormonally-responsive cancer
* elevated liver function test (LFTs)
* atrial fibrillation
* abnormal sodium or potassium levels
* taking medications that directly impact the endocrine system (exogenous hormones, steroids, etc.)
* taking medications that indirectly impact the endocrine system (SSRIs, opioids, finasteride, etc.)
* with untreated hyper- or hypothyroidism
* smoker
* psychiatric history
* Women: not willing to abstain from getting pregnant during the course of the study, with abnormal menstrual cycle, or who have osteoporosis
* Men: with polycythemia
Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye
* Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

* Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 25 mmHg
* Patient using or to use punctual plug within 1 months.
* Patients with contact lens.
Ultrasound as Diagnostic Tool in Diaphragm Dysfunction

The diaphragm is the main muscle for inspiration and vital for ventilation. Multiple diagnostic modalities can be performed in the work-up of suspected diaphragm dysfunction. Fluoroscopy has traditionally been the method of choice in diagnosing diaphragm paralysis and is still widely used in clinical practice, while alternative non-invasive and accessible methods have been available. Superiority of ultrasound over fluoroscopy for the diagnosis of diaphragm dysfunction has been suggested.

The primary objective of this study is to investigate the construct validity of ultrasound in diaphragm paralysis.

To study the sensitivity of ultrasound in diaphragm dysfunction we propose a prospective, operator-blinded, two-center, observational study. Participants will be evaluated for diaphragm dysfunction with fluoroscopy and pulmonary function testing as in standard of care. Additionally, ultrasound will be performed.

Construct validity The primary objective of this study is to investigate the construct validity of ultrasound in diaphragm paralysis. Validity is defined as the degree to which an instrument truly measure the construct(s) it purports to measure. In general, three different types of validity can be distinguished: content validity, criterion validity, and construct validity. Since evaluation with gold standard testing is invasive, as explained in the introduction, criterion validity testing not a feasible option. Therefore, in this study, we use construct validity to provide evidence of validity. Construct validity is defined as the degree to which the scores of an instrument (here: ultrasound) are consistent with scores of other instruments (here: pulmonary function tests, fluoroscopy). Construct validation is often considered less powerful, however, with strong theories and specific and challenging hypothesis, it is possible to acquire substantial evidence. Therefore, specific definitions of 'diaphragm paresis' and 'diaphragm paralysis' regarding diagnostic modalities are established in this protocol before the start of the study

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Suspicion of diaphragm dysfunction based on medical history and/or physical examination; as determined by the treating physician.

Exclusion Criteria:

* Inability for fluoroscopy (e.g. severely limited mobility, or unable to follow vocal instructions).
* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
* Those not able or unwilling to give written informed consent.
* Pregnant women
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients

Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had surgery of cataract extraction combined with introcular lens implantation.
* Patients should be aware of the contents and signed for the informed consent.
Primary Prevention of Cardiovascular Disease Among Female Hospital Employees: The Heart Smart for Women Intervention

This study aims to show that a 6-week program designed specifically for women can lead to sustainable behavior change and improvement in heart disease risk factors over one year among a cohort of 46 female employees recruited from within the Heart Hospital at North Shore University Hospital (NSUH). The program is adapted from book "Heart Smart for Women: Six S. T. E. P. S in Six Weeks to Heart-Healthy Living," written by Northwell cardiologists Dr. Jennifer H. Mieres and Dr. Stacey E. Rosen.

The 6-week intervention will include a weekly didactic session, with each week devoted to a different theme (food, exercise, etc). The intervention will follow the program outlined in the book. We will also be using Yammer, an online discussion group part of the Office 365 suite, to distribute materials and encourage conversations surrounding the theme of the week.

Heart Disease is the leading cause of death in women in the United State. Nine out of ten women have one or more risk factors for heart disease and one in three women will die of heart disease. However, most women are unaware of these statistics. As a result, women are less likely than men to recognize the symptoms of a heart attack and are more likely than men to delay in seeking help. The best ways to educate women about heart disease and change their behavior to prevent heart disease are unknown.

More than 80% of heart disease is preventable but requires both knowledge of risk factors and adherence to lifestyle changes. This program is designed to address these challenges in women, where this is a particular unmet need.

Some prior community and workplace-based studies have demonstrated short term improvements in modifiable risk factors for cardiovascular disease. A community based primary prevention program among disadvantaged women decreased the rate of metabolic syndrome, anxiety, depression and stress.

The economic burden of heart disease on employers is significant although workplace employee wellness programs have not been shown to decrease employer costs. The impact of employee wellness programs on clinical outcome measures have been inconsistent.

This program is designed to educate female employees about their heart disease risk factors and provide tactical support to improve their heart health. Once validated, the program can be rolled out to other employees and to the community.

Eligibility Criteria:
Inclusion Criteria:

* one or more of the following modifiable risk factors for cardiovascular disease \[as defined by the American Heart Association\]:

  1. cigarette smoking
  2. high blood pressure
  3. high cholesterol
  4. abnormal blood sugar
  5. sedentary lifestyle
  6. overweight/obese
* must be an employee of the Heart Hospital at North Shore University Hospital

Exclusion Criteria:

* prior history of heart attack or stroke
* pregnancy
Immune Adsorption Role in Treatment of Resistant Lupus

Background: lupus is a heterogeneous autoimmune disease with autoantibodies formation. Lupus nephritis carries the worst prognosis. C1q deficiency correlates with activity and renal involvement and may help in its evaluation. Therapies include plasma exchange, immune adsorption and recently under evaluation, hemodiafiltration with on-line endogenous re infusion (HFR), in addition to traditional immunosuppressive therapies. Aim: is to evaluate the role of HFR in improving signs and symptoms of SLE activity and laboratory parameters not responding to traditional immune suppressive therapy

Settings and design: A controlled clinical study was conducted on group A, sixty patients with lupus in activity subdivided into cases 1, 47 patients, who received traditional medical treatment and cases 2 group, 13 patients, who underwent HFR in addition to medical treatment. And group B that consisted of two subgroups, control 1, 20 healthy age and sex matched volunteers and control 2, 10 cases with different glomerular diseases other than lupus.

Methods and materials: Serum c1q was done before and after the HFR as well as induction by medical treatment. Disease activity assessed using SLEDAI-2K with responder index - 50, quality of life assessed using SLEQOL v2, and HFR was performed for the non-responder group.

The study will be conducted in Alexandria University Hospitals in compliance with the Declaration of Helsinki; the ethical committee of the investigator's faculty will be requested to approve the protocol and the patients will be requested to give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* systemic lupus erythematosus in activity

Exclusion Criteria:

* End stage renal disease, other renal replacement therapy
Does Asthma Phenotype Have Impact on Disease Control

The application of biomarkers that are more closely associated with eosinophillic airway inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial reactivity could improve asthma control by better directing treatment. A systematic review and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention on clinical symptoms compared with exhaled nitric oxide or induced sputum count.

AHR used as outcome

Eligibility Criteria:
Inclusion Criteria:

* positiv mannitol
* asthma diagnose

Exclusion Criteria:

* other lung disease
Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease

The aim of this study is to establish associations between blood and urine markers of bone metabolism with histomorphometric changes (changes in the actual bone structure) resulting from short term oral prednisolone treatment in patients with COPD (chronic obstructive pulmonary disease).


Eligibility Criteria:
Inclusion criteria:

* Females subjects must be unable to have children.
* BMI 19 - 29.9
* Non-smokers, ex-smokers or current light smokers (\<10 cigarettes/day)

Exclusion criteria:

* High blood pressure
* Other significant disease
* Use of certain medications (to be decided by the investigator)