cyrilzakka/clinical-trials huggingface dataset:
Mind-body Awareness Training and Brain-computer Interface

Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The hypothesis is that MBAT will improve performance in SMR based BCI.

In this protocol, the following hypothesis will be tested; namely that MBAT including the verified mindfulness based stress reduction (MBSR) course will improve the ability for subjects to concentrate on the control of the SMR thus improving the performance of BCI. Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include a standard 8-week MBSR course, and an EEG brain noninvasive brain computer interface study.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy volunteers
* Age 18-64, inclusive.
* Willing and able to provide written consent.
* Able to communicate in the English language.

Exclusion Criteria:

* Any past BCI experience.
* Pregnancy
* Any breathing, movement, or visual disorders.
* Any active neurological or mental disorders.
* History of epilepsy.
* History of a vascular or cardiac disorder (e.g. heart disease)
* History of a metabolic disorder (e.g. diabetes)
* Any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.

Exclusion criteria that would prevent subjects from participating in the optional MRI component will be:

* Any MRI incompatible indwelling metal objects or implantable devices, including but not limited to the following (dental mental is allowable):

  * Cardiac pacemaker
  * Implanted cardiac defibrillator
  * Carotid artery vascular clamp
  * Intravascular stents, filters, or coils
  * Aortic clip
  * Internal pacing wires
  * Vascular access port and/or catheter
  * Swan-Ganz catheter
  * Shunt (spinal or intraventricular)
  * Aneurysm clip(s)
  * Neurostimulator
  * Electrodes (on body, head, or brain)
  * Heart valve prosthesis
  * Any type of prosthesis (eye, penile, etc.)
  * Artificial limb or joint replacement
  * Bone growth/fusion stimulator
  * Bone/joint pin, screw, nail, wire, plate
  * Metal rods in bones
  * Harrington rods (spine)
  * Metal or wire mesh implants
  * Wire sutures or surgical staples
  * Insulin pump or infusion device
  * Any metal fragments (i.e. metal shop)
  * Any implant held in place by a magnet
  * Cochlear, otologic, or ear implant
* Claustrophobia
* Hearing aid use
* Any yoga/meditation in the last three months.
* More than 12 yoga/meditation classes in the last 12 months.
* Approximately weekly yoga/meditation for a year or more at any point in the past.
Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian

This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil.

NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83% oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut oil is used as positive control in this study.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged 20-60 years
* BMI 23 - 27.5 kg/m2
* free from any disease
* not on any medication or treatment associated with reduction of CVD
* non-smokers and non-heavy drinker or having smoking or alcoholic history
* not pregnant or lactating
* willing and able to comply

Exclusion Criteria:

* people on weight reduction therapy/program
* people on cholesterol reduction medicatio
* have one or more of the chronic diseases
* people with blood clotting problem/ coagulopathy / deep vein thrombosis.
* hypertensive persons (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg)
* female who is pregnant
* people travel to overseas during feeding.
Diet Interventions in Psoriatic Arthritis

The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).

The study asks if dietary change and nutritional support improves disease activity and if patients are better able to improve or sustain progress with additional incentives. The study will use an online program to communicate with participants through text and online surveys. This 24-week trial will enroll 90 patients in the US and Canada with New York University as a back-up site.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Required Rheumatologist-confirmed diagnosis of PsA fulfilling Classification of Psoriatic Arthritis Criteria (CASPAR)
* Willing to alter diet and participate for 24 weeks
* Able to attend follow-up visits
* Body mass index (BMI) \> 25 and \<40
* No history of eating disorders such as anorexia or bulimia
* Disease Activity in Psoriatic Arthritis Assessment (DAPSA) \> 10
* Stable treatment for PsA for ≥3 months prior to enrollment (patients may be on any disease modifying anti-rheumatic drugs (DMARDs) or they can be free of systemic medications
* Owns and uses an iPhone or Android smart phone, or is willing to use a device provided by the study team

Exclusion Criteria:

* Inability to provide informed consent
* Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks
* Use of systemic corticosteroids
* All persons who would be placed at an increased risk including any medical condition that will impair the ability of the person to participate in a nutritional intervention study (e.g. insulin dependent diabetes, use of coumadin, advanced malignancy, inflammatory bowel disease, dementia)
* History of food allergy to any of the components of olive oil or nuts
* Inability to read and write in English
* Unwillingness to change dietary habits
* Known pregnancy (pregnancy testing will be performed for women of childbearing age; weight changes will not accurately reflect the changes we would anticipate in pregnant patients and weight loss may be detrimental to maternal and/or fetal outcomes).
* Participation in another physical activity study and/or diet trial
The Value of PSP in Predicting Outcome in ICU Surgical Peritonitis Patients

The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit after abdominal surgery and compare PPS with other blood parameters, including C-Reactive Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).

Peritonitis is a severe complication after abdominal surgery. Patients admitted at the Intensive Care Unit (ICU) following surgery bear the risk of localized infection, sepsis or septic shock. Prevention or early detection of such events is important to intervene with an appropriate therapeutic action and avoid risking a potentially life-threatening situation. White blood cell counts (WCC) and C-Reactive Protein (CRP), Interleucin-6 (IL-6) and Procalcitonin (PCT) have all been promising parameters, however, they are useful only in selective cases and have a limited diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal surgery.
* Admission to the Intensive Care Unit (ICU).
* Blood sampling within 3 hours from admission to the ICU
* Patient over 18 years of age

Exclusion Criteria:

* Patients already treated for peritonitis.
* Patients referred from other hospitals with suspicion of peritonitis
* Patient age less than 18 years of age.
UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder

UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care

We expect the trial to enroll approximately 24 Urea Cycle Disorder (UCD) patients on standard of care with elevated ammonia levels. The planned treatment duration is eight weeks, with a primary endpoint of proportion of subjects who achieve a ≥15% reduction from baseline in fasting ammonia at the end of treatment. Patients will also be followed for safety and tolerability. This clinical trial is intended to allow us to evaluate efficacy of KB195 in reducing ammonia in UCD patients.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent and willing to comply with protocol-specified procedures.
* Has any confirmed UCD other than N-acetyl glutamatesynthase (NAGS) deficiency.
* Is male or female, 12 to 70 years of age (inclusive)
* If ≥ 18 years old, has a BMI ≥20.0 and \< 40.0 kg/m2. If \< 18 years old, has a BMI between 5th percentile and 95th percentile and weight greater than 5th percentile according to age, sex and regionally appropriate growth chart
* Has evidence of poorly controlled disease on the current standard of care (SOC)
* If NBT is part of SOC, is on a stable dose and regimen for at least 4 weeks before Screening and the dose is expected to remain stable during the study
* Is willing to maintain a stable diet throughout the course of study and is willing to continue usual exercise routine.
* If taking probiotics or prebiotics, is on a stable dose regimen for at least 4 weeks before Screening and the dose and regimen are expected to remain stable during the study
* Has a negative urine screen for drugs of abuse at Screening
* If male or female of child bearing potential, agree with use effective method of contraception for the duration of the study and 90 days after last dose of study product

Key Exclusion Criteria:

* Is at a high risk for metabolic decomposition.
* Has had a substantive change in diet or any other aspect of UCD management within 4 weeks before the Screening Visit
* Has used a systemic anti-infective within 4 weeks before the Screening Visit, or use is anticipated during the study
* Has been diagnosed with Citrullinemia Type II
* Is receiving any systemically administered immunosuppressant medication on a chronic basis
* Has changed the use of or dose of any drug or other compound to modulate GI motility within 4 weeks before the Screening Visit, or the use or dose is expected change during the course of the study
* Has a history of or active GI or liver disease
* Has a prior solid organ transplantation including liver transplantation, or is anticipated to receive a liver transplant during study participation
* Has used an investigational drug, product, or device within 30 days before the Screening Visit
* Has a contraindication, sensitivity, or known allergy to the study drug
* Is considered, in the opinion of the PI, to likely be a poor attendee or unlikely for any reason to be able to comply with the study drug procedures
Functional Capacity in Survivors of COVID-19 Related ARDS

Acute respiratory distress syndrome survivors frequently develop impaired physical function, muscle weakness and quality of life. The aim of this retrospective study is to determine the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools. COVID-19 related acute respiratory distress syndrome survivors were assessed 4 weeks following discharge from the hospital, 15 patients who attended the evaluation will be included the study. All subjects underwent standardized physical clinical evaluation, Medical Research Council-sumscore, hand-grip strength, 6-minute walk test, chair-stand test, timed up and go test and Short form-36, 4 weeks after hospital discharge.

COVID-19 could cause acute respiratory distress syndrome in a minority of patients. After recovery from acute critical illness and discharged from hospital, secondary disabilities related to Post Intensive Care Syndrome could take over the role. There is limited data and information about the functional capacity of these patients after hospital discharge.Follow-up these patients after discharge might help assessing the symptoms of Post Intensive Care Syndrome, functional capacity and need of physical therapy, therefore give care for the impairments. The aim of this retrospective cross-sectional study is to demonstrate the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools. Appointment was given all of the ARDS survivors related to COVID-19 who treated in ICU after 4 weeks following discharge from hospital in order to assess the need of rehabilitation. 15 patients who attended the evaluation will be included the study.

Eligibility Criteria:
Inclusion Criteria:

* to be older that 18 years
* Acute respiratory distress syndrome survivors related to COVID-19 who treated in Intensive care unit and attend appointment after 4 weeks following discharge from hospital

Exclusion Criteria:

* History of diseases that could affect functional capacity, muscle strength and quality of life, such as cancer, spinal cord disease, neuromuscular diseases
* do not want to attend the study
Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments in Patients with Carpal Tunnel Syndrome

Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance may be observed. The treatment of CTS can be grouped as nonsurgical and surgical treatments. The aim of this study is to investigate the effects of treatment with sound waves and a healing method called extracorporeal shock wave therapy and a therapeutic flexible tape called kinesiology taping on pain, grip strength, quality of life, depression symptoms, hand functions, and ultrasonographic median nerve cross-sectional area in patients with CTS.

Carpal tunnel syndrome is the most common nerve entrapment syndrome, typically affecting the dominant extremity. Symptoms often become more pronounced at night, and may include numbness, tingling, electric shock sensations, pain, and other related symptoms. Diagnosis can be made based on patient history, physical examination, electrodiagnostic tests, and ultrasonography. Treatment options include splinting, exercise therapy, physical therapy modalities, various injections, and surgical methods.

In our study, we compared the effects of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KT) on carpal tunnel syndrome. The study involved four randomized groups: Group 1 received both ESWT and KT, Group 2 received only ESWT, Group 3 received only KT, and Group 4 received exercise therapy alone. Evaluations were conducted using the Visual Analog Scale, Boston Carpal Tunnel Questionnaire, Douleur Neuropathique 4 Questions, Nottingham Health Profile, grip strength measurements, and median nerve cross-sectional area via ultrasonography. Evaluations were performed three times: before treatment, at week 3, and at week 6.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate unilateral carpal tunnel syndrome confirmed by electroneuromyography (ENMG)
* Patients over 18 years of age
* Symptom duration of at least 3 months
* Those who have not received any medical treatment other than analgesics in the last 3 months

Exclusion Criteria:

* Bilateral Carpal Tunnel Syndrome (CTS)
* Severe CTS detected by ENMG
* Operated CTS
* Corticosteroid injection within the last 3 months
* History of peripheral nerve damage
* Secondary CTS causes (thyroid dysfunction, connective tissue diseases)
* Cervical disc herniation
* DeQuervain tenosynovitis, trigger finger, Dupuytren contracture
* Inflammatory disorder
* Bleeding disorder
* Pregnancy
* Malignancy
engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions

The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.

The study is focused on older people with mild cognitive impairment, aiming to improve their quality of life and well-being, allowing them to preserve their identity, to reduce stress, memory loss, or communication challenges by the use of the technological engAGE system that includes the social robot Pepper. The social robot can be a great tool in engaging older adults in this kind of activities. It is always available and able to provide verbal clues or suggestions according to older adult's wishes, needs and memories. Moreover, the social robots may coach the older adults to perform daily activities with greater independence (i.e. coaching stepwise prompting to complete activities in-home) and support to caregivers as well.

Since caring for people with mild cognitive impairment puts a significant burden on informal caregivers, having the support of a technological platform can reduce anxiety, worries, and stress. The caregivers can personalize the content of interventions to the wishes and preferences of the older adults. Together with the older adults, they can be involved with the robot in joyful and fun activities like drama playing, storytelling, etc.

The formal caregivers who need to keep track of older adult progress which is a difficult and time-consuming process due to the lack of objective monitoring of cognitive decline and wellbeing may get valuable support from the cognitive assessment procedure implemented by the machine learning algorithm. Also, the social robot and tablet may facilitate the follow-up of older adults through reminders and cognitive interventions.

Eligibility Criteria:
Inclusion Criteria:

* mild cognitive impairment (MCI);
* Montreal Cognitive Assessment (MoCA) score 21 - 25;
* Memory Assessment Clinics - Questionnaire (MAC-Q) ≥ 25;
* Reisberg scale 2 - 4;
* Clinical Frailty Scale score 1 - 3;
* 4-items GDS score ≤ 1;
* have an informal caregiver to support in carrying out the main daily activities.

Exclusion Criteria:

* lack of informal caregivers;
* significant visual or hearing impairment.
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects

This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.


Eligibility Criteria:
Inclusion Criteria:

* To be considered as 'Japanese', both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for more than 5 years
* Have a body mass index (BMI) between 17 and 27 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg.
* Females must not be lactating, and must be of non-childbearing potential (post-menopausal at least 12 months or documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation

Exclusion Criteria:

* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Symptoms of a clinically significant illness in the 3 months before the study
* History of hypersensitivity (eg, anaphylaxis), serious allergy, or any serious reaction to carbapenem, cephalosporins, or other β-lactam antibiotics
* Use within 14 days prior to the first study dose of any over-the-counter (including St. John's Wort or any herbal products) or prescription medication
* Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months
Feasibility and Functionality Test of Ada's DDSS Prototype

This study is to explore with a feasibility and functionality test the potential of the Ada DDSS prototype with cases of dyspnea patients using the data collected at the Emergency Department (ED) and the ward of Internal medicine of the University Hospital Basel.

This is an observational i.e. non-interventional, prospective feasibility study, which assesses, through observation, the potential, functionality and diagnostic performance of the Ada DDSS prototype in evaluating patients presenting with dyspnea as primary predominant complaint to the ED.

Once the consent form is signed, the Investigator documents patients' data, medical history, symptoms and findings with the Ada DDSS prototype. During the entire patient journey through the hospital (presentation at the ED through to admission in the ward of Internal Medicine) relevant information are collected and documented in the Ada DDSS prototype simultaneously to standard documentation by the medical staff.

Examination and treatment are carried out by the attending physician without being influenced or affected by the entry of data in the Ada DDSS prototype.

There is no intervention/change made to the usual care, and therefore neither an intervention patient group nor a control patient group. The "usual care" that each patient receives is the control comparison point for the performance of the Ada DDSS. The diagnoses proposed by the tool at different times (after triage in the emergency centre, when transferred to the ward and when discharged from the hospital) are then compared with those of the attending physician.

Eligibility Criteria:
Inclusion Criteria:

* Dyspnea as the main symptom when entering the emergency room
* Existence of written consent
* The patient is able to speak, understand and read German or English.

Exclusion Criteria:

* Inability or unwillingness to understand and comply with study procedures due to:
* Language problems
* Acute mental disorders
* Dementia
* Clinical instability (e..B. resuscitation treatment, non-invasive ventilation, etc.)