cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage

The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) and stroke patients.

Brain damage may lead to various motor deficits, which further influence the activities and participation. Cerebral palsy (CP) and cerebral vascular accident (CVA) are the common disorder for congenital and acquired brain damage, respectively. It would be ideal to characterize neural network in patients with brain damage that underlies their clinical behavior by identifying altered neural network associated with behavioral improvement.

The investigators hypothesize that the level of motor control and impact of brain image will change with time in patients with brain damage. Under this hypothesis, the measures of motor control are correlated with neural changes reflected by imaged using structural MRI, resting state fcMRI, and active fMRI sequences. The aim of this study is to investigate the motor control and brain image in patients with brain damage evaluated by clinical measures and multimodel imaging studies such as structural MRI, resting state fcMRI, and active fMRI. The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in CP and stroke patients. This study will be executed in 3 years: 1st phase: to establish the multimodal brain images and motor control in healthy subjects; 2nd phase: to establish the brain images and motor control in patients with stroke.; and 3rd phase: to establish the brain images and motor control in patients with CP. Additionally, the association between brain images and clinical changes involving movement and participation will be analyzed. The investigators will identify the predictors influencing final outcome and analyze. The differences in structural image, functional connectivity and brain activation between patients with brain damage and healthy controls can potentially be a bio-marker for prognosis. The investigators believe the results of this study will allow clinicians to understand the brain mechanisms underling motor control and early predict the outcome for patients with brain damage.

Eligibility Criteria:
Inclusion Criteria:

1. CP-patients with CP and aged 6-18 years
2. CVA-patients with stroke and aged 40-75 years

Exclusion Criteria:

1. contraindication to MRI
2. history of psychiatric disease
3. received BTX-A injection or surgery in recent six months
4. severe psychological impairments, such as mental retardation, autism or severe communication problems
5. progressive disorders, such as neurodegenerative disease
6. active medical disease, such as infection
Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students

This study aims to address the following research questions:

Evaluate the effectiveness of an Interactive Mental Wellness (I-AM-WELL) program on final year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours.

Explore final year nursing students' experiences and perception of the I-AM-WELL program.

Participants will be invited to participate in an asynchronous online I-AM-WELL program


Eligibility Criteria:
Inclusion Criteria:

* Final year nursing students enrolled in the undergraduate nursing program
* Above the ages of 18 years
* Able to comprehend the English language
* Have a device that can connect to the Internet

Exclusion Criteria:

* Students who refused to participate in the study
Investigation of the Effects of Pilates Training Combined with Whole Body Vibration on Balance and Mobility in Individuals with Multiple Sclerosis

The aim of this study is to investigate the effects of Pilates training combined with whole-body vibration (WBV) on balance and mobility in individuals with Multiple Sclerosis (MS). The main questions it aims to answer are:

* Are the improvements in core stability, lower limb functional muscle strength, balance and mobility obtained with Pilates training combined with WBV (Pilates-WBV) in individuals with MS greater than with Pilates training alone?
* Are the improvements in upper extremity performance and fatigue obtained with Pilates-WBV training in individuals with MS greater than with Pilates training alone?

Researchers will compare Pilates-WBV training with a group that received Pilates training alone to see if there is any additional benefit.

Participants will:

* Take Pilates-WBV or Pilates training twice a week for 6 weeks
* Be evaluated with pre- and post-training


Eligibility Criteria:
Inclusion Criteria:

* Definitive Multiple Sclerosis diagnosed by a specialist
* Expanded Disability Status Scale (EDSS) score between 0-5
* Accepting participation in the study voluntarily

Exclusion Criteria:

* An MS attack within the last three months
* Pregnancy
* Endoprosthesis or electronic implant
* A cardiovascular, pulmonary or orthopedic disease
* A disease that can affect the immune system, such as infection or cancer
* Additional neurological disease
Engaging Caregivers in Dementia Care

This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes.

Dementia care guidelines and pharmacological and non-pharmacological treatments have been shown to reduce symptom burden and rates of institutionalization for individuals with dementia. However, there remain a variety of factors that complicate dementia care management in primary care settings. Patient-centered, integrated care management programs that involve caregiver (CG) education and psychosocial support may help facilitate access to and use of services and improve outcomes. The aims of this pilot were to examine 1) whether, relative to usual care (UC), a dementia care management program is associated with improved CG (e.g., mastery, burden, affect) and patient (e.g., behavioral symptoms) outcomes, 2) if, relative to UC, participants enrolled in the program have greater perceived access to and use of medical, social, and community/VA services, and 3) whether the dementia care management program is feasible and acceptable to participants.

Eligibility Criteria:
Inclusion Criteria:

* Patient and caregiver 18 years of age or older
* Patient is community dwelling
* Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
* CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
* Veteran provides assent to contact his/her representative to pursue study participation
* Veteran representative as caregiver is willing and able to provide informed consent

Exclusion Criteria:

* Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
Effect of TyG Index on Outcomes of Radical Prostatectomy

We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in patients undergoing radical prostatectomy.

TyG index is calculated with special formula. Patients undergoing radical prostatectomy are divided two groups according to the cut-off level of 8.55 for TyG index.Groups were compared statistically in terms of oncological outcomes and survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing radical prostatectomy for prostate cancer

Exclusion Criteria:

* taking medicines for established diabetes and dyslipidaemia,
* presence of endocrinological disease,
* history of bariatric surgery,
* missing data and patients with uncontrolled follow-up
Melatonin Supplementation and Performance

The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon short-term performances, on the following morning. Twelve soccer players from a Tunisian squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three testing sessions, with one test session per day. During each session, MEL (5mg) , MEL (8mg) or placebo were ingested, in a randomized order, before nocturnal sleep. The next morning (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's index, reaction time, vigilance, handgrip strength , squat jump , modified agility test , Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of perceived exertion was recorded immediately after the WanT, and blood lactate measures were taken after 3min of recovery. Blood glucose was measured before and 3 min after the Wingate test.


Eligibility Criteria:
Inclusion Criteria:

The participants were recruited based on the following criteria: (i) paticipants must be trained at 4-6 days per week for an average of 2 h daily and (ii) they must have at least 8 years of training experience

Exclusion Criteria:

* Subjects were excluded from the study if they present one of the following criteria : heart failure, antioxidant supplementation within 3 months before the study, lower-limb injuries
ANTI-SARS-CoV-2 SEROCONVERSIO IN IMMUNE-MEDIATED KIDNEY DISEASES

This is a multicentric, observational, retrospective study. The primary endpoint of the study is to investigate the humoral immunological response to SARS-Cov-2 vaccination in this population, looking for clinical features predisposing to seroconversion failure.

Secondary endpoints are

* to investigate the appearance of symptomatic SARS-CoV-2 infection, despite vaccination, looking for any clinical features predisposing to infection,
* to identify the protective cut-off of antibody titer against SARS-CoV-2 infection.

Each study participating center will select all vaccinated patients with immune-mediated renal diseases for whom anti-COVID serology will be available.

SARS-CoV-2 infection produces a quantifiable immune response. Post-infection immunity consists of a humoral and cell-mediated response, which appears to reduce the risk of SARS-CoV-2 re-infection for at least 6 months in the healthy population. It is reasonable to assume that SARS-COV-2 vaccination may also induce a similar response.

In immunomediated renal disease patients, it is not known what the antibody response is, what factors can potentially influence it, other than immunosuppressive therapy. This information, on the other hand, is useful not only in identifying individuals at risk of infection despite vaccination but it can help to personalize the vaccination schedule.

All patients with immune-mediated renal diseases undergoing the complete vaccination cycle (one or two doses depending on the type of vaccine used) against SARS-CoV-2, and for whom at least one dosage of anti-SARS-CoV-2 antibodies are eligible.

After obtaining signed informed consent, personal data, underlying disease, biochemical parameters (including immunoglobulin assay and lymphocyte typing, if available), present or previous comorbidities, immunosuppressive therapies, dosage of SARS-CoV-2 IgG antiSpike and/or antiRBD/Spike antibodies, the date of vaccinations and the type of vaccine performed will be extracted.

The data are all present in the patients' inpatient and/or outpatient medical records, as part of normal clinical management and completely independent of participation in the current clinical trial.

The interview with the patient will show the possible appearance of COVID-19 infection, the date of his diagnosis, confirmed by a positive molecular swab, the degree of severity and the clinical course.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age ≥ 18 years 2. MRI diagnosis (biopsy and non-biopsy) 3. At least one complete vaccination cycle according to the indications of the NHS (consisting of two doses or a single dose depending on the type of vaccine) 4. Signing of informed consent 5. At least one dose of anti-SARS-CoV2 IgG antibodies performed after a complete vaccination course

Exclusion Criteria:

* SARS-CoV-2 infection, before or during the vaccination cycle (between I and II dose), diagnosed by molecular swab or positivity to anti-Nucleocapsid antibodies or anti-Spike IgM.
Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.

The study investigates whether additional metformin medication in combination with regular insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1 during pregnancy.

Insulin resistance during pregnancy of diabetes mellitus type 1 patients (DM1) increases the need for insulin and makes it more difficult to maintain normoglycemia. Fetal exposure to hyperglycemia induces macrosomia which increases fetal and neonatal morbidity and mortality. Further more obesity and excess weight gain during pregnancy enhances insulin resistance and it's an independent risk factor for fetal macrosomia.

Metformin is a medical treatment for type 2 diabetes (DM2) where consequential pathophysiology includes insulin resistance. It reduces hepatic glucose production and enhances the use of glucose in muscles relieving insulin resistance. Metformin has also found to inhibit weight gain effectively.

Metformin has approved to be safe and effective in patients with gestational diabetes (GDM). It has found to reduce weight gain and improve postprandial blood glucose levels during pregnancy and reduce neonatal birth trauma in GDM. However, there are no previous studies about the use of metformin in pregnant women with DM1.

Two hundred women with DM1 will be randomized to get placebo or metformin in addition to regular insulin treatment. The sample size has been estimated to demonstrate the difference of 15 % in the need to increase insulin dosages during the pregnancy between the study groups.

Eligibility Criteria:
Inclusion Criteria:

* a pregnancy of a woman with type 1 diabetes.

Exclusion Criteria:

* multiple pregnancy, significant underlying disease (hearth disease, kidney transplant, IBD (inflammatory bowel disease ), SLE (systemic lupus erythematosus ), diseases with use of high dosage corticosteroids (severe asthma or rheumatic disease), severe complications of diabetes (nephropathy, neuropathy, gastroparesis or severe retinopathy), substance abuse, smoking, BMI \<18, strong early pregnancy nausea (=hyperemesis)
High Water Intake to Slow Progression of Polycystic Kidney Disease

Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
* Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
* Ages between 18 and 65
* Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) \> 60 ml/min/1.73 m2 with no history of kidney disease

Exclusion Criteria:

* Women who are pregnant or nursing
* Active dependency on drugs or alcohol
* Diagnosis of syndrome of inappropriate antidiuresis
* Currently taking a vasopressin agonist or antagonist
* Blood sodium level less than \< 135 mEq/L
* For healthy participants, estimated glomerular filtration rate (level of kidney function) less than \< 60 ml/min/1.73 m2
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration
* Body weight \</=150 kg
* Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment
* Patients with inadequate clinical response to a stable dose of non-biologic DMARD

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
Cardiac-Control Affecting Learning Through Mindfulness (CALM)

Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. The current study is designed to investigate how daily mindfulness practice with heart rate biofeedback during breathing in a pattern that either increases or decreases heart rate oscillation affect attention and memory and blood biomarkers associated with Alzheimer's disease.


Eligibility Criteria:
Inclusion criteria

* Fluent in English
* Black/African-American or White/European-American
* Aged between 50-70 years old
* Non-pregnant and non-menstruating (for at least the past year)
* Have normal or corrected-to-normal vision and hearing
* Have reliable access to wifi
* Have an email account that you check regularly
* Have a phone that receives text messages
* Agree to provide blood and urine samples at two campus visits
* Agree to devote up to 50 minutes daily to this study for 10 weeks as well as attend two campus visits

Exclusion criteria

* Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)
* Have cognitive impairment
* Have regularly played Lumosity games in the past 6 months
* Have any conditions listed below that are not safe for MRI

  * \*Metal in any parts of your body
  * Claustrophobia
  * Have worked as a machinist, metal worker, or in any profession or hobby grinding metal?
  * Have had an injury to the eye involving a metallic object (e.g., metallic slivers, shavings, or foreign body)
  * Cardiac pacemaker
  * Implanted cardiac defibrillator
  * Aneurysm clip or brain clip
  * Carotid artery vascular clamp
  * Neurostimulator
  * Insulin or infusion pump
  * Spinal fusion stimulator
  * Cochlear, otologic, ear tubes or ear implant
  * Prosthesis (eye/orbital, penile, etc.)
  * Implant held in place by a magnet
  * Heart valve prosthesis
  * Artificial limb or joint
  * Other implants in body or head
  * Electrodes (on body, head or brain)
  * Intravascular stents, filters
  * Shunt (spinal or intraventricular)
  * Vascular access port or catheters
  * IUD
  * Transdermal delivery system or other types of foil patches (e.g., Nitro, Nicotine, Birth control, etc.) that cannot be removed for MRI
  * Shrapnel, buckshot, or bullets
  * Tattooed eyeliner or eyebrows
  * Body piercing(s) that cannot be removed for MRI
  * Metal fragments (eye, head, ear, skin)
  * Internal pacing wires
  * Aortic clips
  * Metal or wire mesh implants
  * Wire sutures or surgical staples
  * Harrington rods (spine)
  * Bone/joint pin, screw, nail, wire, plate
  * Wig or toupee that cannot be removed for MRI
  * Hair implants that involve staples or metal
  * Hearing aid(s) that cannot be removed for MRI
  * Dentures or retainers that cannot be removed for MRI
An Online Intervention Addressing Mental Health and Substance Use in University Students

The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students.

There is a need for scalable interventions to support the mental health and substance use challenges experienced by university students. One means of addressing this need is through the use of e-mental health tools that facilitate self-management and connect students to in-person supports as needed. This is a randomized controlled trial of a mobile app designed to help university students manage their mental health and substance use via a set of evidence-based tools that have been integrated into a single mobile app. The recruitment of approximately 1500 students will occur through social media, promotion by faculty members and administrators, and other in-person recruitment methods. Assessments will be conducted using self-report web surveys at baseline, 14 days (interim assessment) and 30 days (follow-up assessment). The goal of the trial is to assess the effectiveness of the app in improving a range of mental health and substance use outcomes of university students from baseline to follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Must be currently enrolled at participating university
2. Must be 17 years or older
3. Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
4. Must be English speaking

Exclusion Criteria:

1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment