cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent

The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations.

Neurotypical children aged 10-15 participated in the study. All subjects were assessed using the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version Korean Version (K-SADS-PL-K) and confirmed to have no psychiatric symptoms. The participants were randomly assigned to the MNF active (N=31) or sham control (N=30) groups. The MNF program was administered using a mobile app (equipped with a headset with a 2-channel EEG sensor) for 30 min/day, 3 days/week, for 3 months. All participants and their parents completed self-report scales and participants complete neurocognitive function assessments including the continuous performance test, Stroop, children's color trails test-1 and 2, and intelligence test at baseline and after the 3-month MNF program.

Eligibility Criteria:
Inclusion Criteria:

Child participants ranging from 8 to 15 years of age, who were recruited from the Department of Psychiatry at Daegu Catholic University Medical Center between 2019 and 2021

Exclusion Criteria:

History of congenital genetic diseases History of brain damage History of neurological disorders History of psychiatric conditions such as schizophrenia spectrum disorder, autism spectrum disorder, obsessive-compulsive disorder, major depressive disorder, or bipolar disorder Participants with an IQ below 70, as determined by the Korean-Wechsler Intelligence Scale for Children-Fourth Edition (K-WISC-IV)
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis

To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.

In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.

Eligibility Criteria:
Inclusion Criteria:

1. patients older than 50 years
2. a diagnosis of primary knee osteoarthritis
3. Kellgren-Lawrence (K-L) grading scale smaller than 3
4. both male and female.

Exclusion Criteria:

1. patients younger than 50 years of age
2. K-L grade 3 or more
3. history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
4. generalized OA
5. the detection of rapidly progressive OA before the start of the trial
6. underwent any previous lower extremity surgery
7. excessive mechanical axis deviation (varus \> 5°, valgus \> 5°)
8. body mass index larger than 30
9. history or presence of malignant disorders
10. systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
11. systematic or intra-articular corticosteroid therapy in the previous 3 months
12. prior treatment with HA in the past 6 months
13. anticoagulants or antiaggregants therapy in the preceding 30 days
14. non-steroidal anti-inflammatory medications in the preceding 7 days
15. platelet count less than 150,000/ml of blood
16. hemoglobin values less than 12g/dL of blood.
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years
* Body mass index ≥19.0 to ≤30.0 kg/m2
* Body weight \>55 kg"

Exclusion Criteria:

* Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)
* Subjects who have received any IMP in a clinical research study within the previous 3 months
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers who smoke more than 10 cigarettes per day
* Positive drugs of abuse test result
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Effect of Physical Activity on Academic Stress While Controlling the Confounding Variables

The study is designed to determine the effectiveness of moderate physical activity on academic stress with controlling and observing on confounding variables.

Now a days, modern time, new researches increased knowledge of researchers on physical activity and its effect on academic stress. Literature search shows to reduce academic stress among people all types of physical activities were effective and useful. Particularly moderate level of physical activity like brisk walking was significantly associated with academic stress, as compare to hard and light physical activities. Many Studies and research was available on the effectiveness of physical activities and found effective for dealing with academic stress but these were single centered and lacking control on confound variables observation, For example, Age, BMI, Socio-economic status, Semester pressure, Curriculum burden, depression, anxiety ,stress , demographics etc were absent in previous studies plus the available research is partial, includes only females. This research will be impartial and free from gender discrimination. Both male and female students will be taken in consideration for test and a multi-centered study will be conducted focusing on the confounding variables to determine the effectiveness of physical activity on academic stress with controlling variables is the recommendation of this research

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Moderate academic stress

Exclusion Criteria:

* Participant falling in this category would be excluded from the study.
* Physical Disability
* Acute infection
* Chronic infection
* Acute inflammation
* Chronic inflammation
* Known osteoporosis
* Individual with respiratory diseases e.g. asthma
* Smoking
* Musculoskeletal injuries

Confounding variables:

* Age
* Gender
* BMI
* Socio-economic status
* Semester
* Depression, anxiety and stress
* Demographic (rural, urban)
* Relationship status (married and unmarried)
Health Outcomes Via Positive Engagement in Schizophrenia

This is an observational study where digital, clinical and health utilization data are collected from individuals with schizophrenia spectrum disorders who have been recently discharged from a psychiatric hospitalization. The data will be used towards building a model/algorithm capable of monitoring mental health and predicting adverse clinical events, such as relapse and re-admissions.

In this research, participants will attend 6-weekly follow-up research visits (Weeks 0, 6, 12, 18, 24) over 24 weeks where clinical symptoms, cognition, functioning and well-being will be assessed. Passive digital data from smartphones and wrist wearable devices (e.g. sleep patterns, heart rate, location variance and entropy, phone usage frequency and duration, finger taps, ambient light, and physical activity) will be collected continuously during the 24 weeks. Audio recorded follow-up phone calls will be made to participants who consented to the optional audio recorded component at Weeks 3, 9, 15, 21. This study will also carry out an administrative follow-up at Week 24/termination and Week 52 to obtain healthcare utilization information (e.g. scheduled or unscheduled appointments, readmission, etc) since study enrollment.

Study findings will shed light on the relationship between digital biomarkers with clinical status and health utilization outcomes, as well as explore the feasibility and acceptability of digital sensors.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female aged 21 to 65 years (inclusive) at time of informed consent
* Has capacity to give informed consent
* Able to understand and comply with instructions in English
* Diagnosis of schizophrenia spectrum disorders assessed using the Structured Clinical Interview for DSM Disorders (SCID)
* Discharged patients from IMH (within 8 weeks post-discharge from IMH)

Exclusion Criteria:

* Female who is currently pregnant or planning a pregnancy within 6 months
* Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect participant safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
* Has visual or physical motor impairment that could interfere with study tasks
Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

This is a prospective cohort study of patients seeking care for chronic low back pain. All patients will undergo a detailed history and physical examination, followed by other indicated diagnostic testing. The analysis will correlate findings from patient history and physical examination testing with the eventual diagnosis. The goal of the study is to identify key historical and physical examination criteria that raise the suspicion for sacroiliac joint pain, which is commonly underdiagnosed. Failure to diagnose a health condition could lead to inappropriate surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient being evaluated in clinic for chronic low back or buttocks pain with or without radiation to the legs

Exclusion Criteria:

* Patient has already undergone surgery for the condition of interest
* Inflammatory condition
* Active cancer
Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus

Major cardiovascular events are greatest in liver transplant recipients with sustained post-transplantation diabetes1. However, the optimal A1c target after transplantation has not been studied. The objective is to understand the optimal A1c target post liver and combined liver and kidney transplant. Strict A1c control will improve mortality and cardiovascular risk post liver and combined liver and kidney transplant and improve complications post liver and combined liver and kidney transplant.

Major cardiovascular events are greatest in liver transplant recipients with sustained post-transplantation diabetes. However, the optimal A1c target after transplantation has not been studied. The objective is to understand the optimal A1c target post liver and combined liver and kidney transplant. Strict A1c control will improve mortality and cardiovascular risk post liver and combined liver and kidney transplant and improve complications post liver and combined liver and kidney transplant.

Strict blood sugar control in non-transplant patients with diabetes mellitus has shown unfavorable results in previous studies. However, no optimal A1c level has been studied in liver and combined liver and kidney transplant patients. Furthermore, guidelines for A1c target post-transplant are of expert opinion.

The primary objective is to assess the impact of hemoglobin A1c on all-cause mortality among patients with diabetes mellitus undergoing liver or combined liver and kidney transplantation between 2008 to 2018. The second objective is to assess the impact of hemoglobin A1c on complications post liver or combined liver and kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years old or older in the United States with diabetes undergoing or post liver and combined liver and kidney transplant from January 2008 to December 2018.

Exclusion Criteria:

* \<18 years old
Cognitive Enhancement in Depression (The COG-D Study)

This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).

The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+ years
* Diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) using Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
* In total, participants must have 2 or more lifetime depressive episodes to be considered "recurrent"
* Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment
* Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog)
* English fluency

Exclusion criteria:

* Other Axis I psychiatric conditions via the DSM-5, except for anxiety symptoms occurring in a depressive episode
* Acute suicidality on clinical evaluation
* Acute grief
* History of alcohol use disorder or substance use disorder in last 12 months
* Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
* Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease)
* Montreal Cognitive Assessment (MoCA) score \< 23
* Primary amnestic cognitive profile (\>1.5 standard deviations (SDs) below demographically-adjusted mean on National Alzheimer's Coordinating Center (NACC) memory measures in context of otherwise normal cognitive profile)
* Any physical or intellectual disability affecting ability to complete assessments
* Unstable medical illness needing urgent treatment
* MRI contraindications
* Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months
* Current involvement in psychotherapy
* Current involvement in other research studies (including but not limited to: neuromodulation \[TMS or tDCS\] or investigational drug studies)
Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy

The purpose of this clinical study is to test whether or not patients treated with HBOT for diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index (RHI) measured by the peripheral arterial tonometry (PAT).

Measurement and monitoring of endothelial function can be used for prediction of outcome in acute, severe disease. Diabetic patients have a poorer peripheral vascular function measured by peripheral arterial tonometry (PAT) as compared to normals, but the effect of hyperbaric oxygen therapy (HBOT) on endothelial function in these patients is unknown. Measurement of PAT in patients with diabetic foot ulcers undergoing HBOT, may help to improve treatment and changes in the reactive hyperemic index (RHI) might correlate with wound healing in these patients.

Peripheral arterial tonometer (PAT) has been shown to be an easy, fast and standardized method for measuring the peripheral arterial endothelial function. The method is also operator-independent and has a high reproducibility.

The PAT apparatus (ENDOPAT) measures the post-ischemic response to a five-minute blood flow occlusion of the upper arm, and the relationship between the pre-and post-ischemic pulse amplitude is expressed as a reactive hyperemic index (RHI). The normal RHI in young healthy persons is more than 2, while in critically ill patients and patients with diabetes, hypertension or heart disease it is significantly decreased.

The study aims to test whether or not patients treated with HBOT for diabetic foot ulcers will demonstrate an improvement of the endothelial function in the peripheral vessels, i.e. an increase in RHI measured by the PAT. Similarly, essential mediators of angiogenesis and nitric oxide bioavailability will be measured in peripheral blood taken during the PAT measurements which will be performed at the time of inclusion, before HBOT and subsequently for each 10th HBOT session.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with foot ulcer
* None diabetic patients
* Age \> 18 years
* Patients referred to hyperbaric oxygen therapy.
* Patients who have given written informed consent to participate in the study

Exclusion Criteria:

* Patients who cannot cooperate to participate in the study
* Patients who do not understand or speak Danish or English
* Allergy to the materials used in the experiment.
* Patients \< 18 years
Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults

With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be potentially effective in preventing and treating obesity and cardiovascular risks if proven in humans. However, human trial still have not been reported with KCJ supplementation. In the present study, we investigated the hypothesis that KCJ supplementation can be decrease the body fat and improve blood lipid profiles in overweight adults.

The aim of this study was to evaluate the efficacy of KCJ supplementation on anthropometric parameters, visceral fat/subcutaneous fat, and blood lipid profiles in overweight subjects.

Sixty overweight subjects with BMI \>25 kg/m2 and waist-hip-ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly assigned to either KCJ supplement (n=30, 32 g/day) or placebo (n=30, 32 g/day) group for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>25kg/m2 and 2)Waist-Hip Ratio (WHR): WHR\> 0.90(male), WHR\>0.85(female)

Exclusion Criteria:

* lipid metabolic disorders
* \>10% changes in body weight in the past 3 months
* Cardiovascular disease such as arrhythmia, heart failure, myocardial infarction, and wearing pacemaker
* Allergy or hypersensitivity to any of the ingredients in the test products - History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in other clinical trials within the past 2 months
* Abnormal hepatic liver function, renal disease such as acute

  * chronic renal failure, nephrotic syndrome
* Use of anti-psychosis drug therapy within 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* History of alcohol or substance abuse
* Pregnancy or breastfeeding
The Effect of a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People

Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people.


Eligibility Criteria:
Inclusion Criteria:

* Able to undergo physical activity for 60 minutes
* Participates in a physical activity center at least twice a week

Exclusion Criteria:

* Scores beneath 24 on MMSE
* Unable to sign a consent form
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)

This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are:

Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)

Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).

14 Clinical Centers across US are recruited to participate in this study.

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. Parallel to this cluster-RCT, a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, we have identified 14 clinical centers to participate; 7 Veterans Health Administration (VHA) systems and 7 non-VHA, Academic Medical Centers.

Comparative Approaches:

1. Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1, 2 and 3 months. .
2. Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

Patients with new onset or ongoing complications of End Stage Liver Disease including Hepatocellular Cancer (HCC) (irrespective of their transplant status), with a caregiver willing to participate.

Exclusion Criteria:

MELD\> 30 or Expected life expectancy of less than 6 months