cyrilzakka/clinical-trials huggingface dataset:
Autism Research Project With Non-Invasive Near-Infrared Light Stimulation

The investigators have previously shown that the administration of low-level infrared light is a safe and non-invasive procedure which improves cognition and emotion, as well as enhances brain metabolic activity. Based on previous studies, the investigators hypothesize that this methodology, called low-level light therapy or photobiomodulation, could be used to improve behavioral symptoms in individuals with autism spectrum disorder (ASD).

The Gonzalez-Lima Laboratory at the University of Texas at Austin will be recruiting participants for a study investigating whether transcranial infrared light stimulation, or TILS, is beneficial for people diagnosed with autism spectrum disorder (ASD).

The molecular target of TILS is cytochrome c oxidase, a mitochondrial enzyme which is crucial for oxygen utilization. People with ASD show impaired mitochondrial function (Siddiqui, Elwell, and Johnson, 2016), as well as alterations in the prefrontal cortex (Amaral, Schumann, and Nordahl, 2008), which plays a key neurological role in mediating attention, impulse control, and social cognition functions.

The lab has previously shown that TILS, delivered to the prefrontal cortex, can be used to improve cognitive functions such as attention (Barrett and Gonzalez-Lima, 2013), executive function (Blanco, Maddox, and Gonzalez-Lima, 2017), and emotional regulation (Zaizar, Papini, Gonzalez-Lima, and Telch, 2021). This cognitive enhancement from TILS is accompanied by an increase in oxygenation of the prefrontal cortex (Holmes, Barrett, Saucedo, O'Connor, Liu, and Gonzalez-Lima, 2019). Recently, the beneficial effects of TILS on ASD symptoms have been safely explored in adults (Ceranoglu et al., 2022) and children/adolescents (Pallanti et al., 2022).

The goal of the study is to recruit children, adolescents, and adults, either ASD or non-ASD, for a study of the effects of repeated administration of TILS on autistic behavior. Participants will be asked to give informed consent, complete a series of questionnaires and cognitive tests, and wear a headband to non-invasively monitor brain activity using near-infrared spectroscopy. TILS is administered non-invasively with a headband device that uses light-emitting diodes (LEDs), which are cleared as safe for use in humans by the Food and Drug Administration (FDA), but the device has not been approved by the FDA for the specific investigational use in this research. The study will train participants (or caregivers) on how to use the LED device, then send the participants home to use the LED device. The investigators will contact participants once a week to check progress. At the end of the study, participants return for the same assessments, at which time the participants will return the LED device.

Eligibility Criteria:
Inclusion Criteria:

* Age between 4-60 years

Exclusion Criteria:

* Current pregnancy
Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent.
2. Diagnosed with Diabetes.
3. An Active Diabetic Ulcer larger than 5 cm2
4. Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)\>=0.5

Exclusion Criteria:

1. Pregnancy.
2. The patient is under another research protocol.
3. One of the following:

   A. ABI\<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
4. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
5. Sufficient Noncompliant.
6. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids
Presenteeism in Severe Asthma Treated by Biotherapyasthma

Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled corticosteroids combined with a second controller, most often a long-acting bronchodilator. It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity, and impaired quality of life. Severe asthma could therefore be associated with major presenteeism, defined as the presence of an employee at work despite his health issues and which implies a limitation of the employee's productive capacity. Uncontrolled asthma and co-morbidities of asthma have been shown to be associated with a decrease in work productivity that includes absenteeism and presenteeism. Although there is little data, a recent study found a decline in work productivity in severe asthma. Various factors associated with presenteeism could be involved, such as asthma control, frequency and severity of exacerbations, comorbidities, or treatments.

Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma control, decrease the frequency of asthma exacerbations which are major determinants of quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could therefore be associated with a decrease in presenteeism.

The objective of the study is to describe the evolution of presenteeism at work, evaluated by the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors associated with this evolution


Eligibility Criteria:
Inclusion Criteria:

* Severe asthma defined as the use of a high doses of inhaled corticosteroids combined with a second controller (GINA 4) and / or oral corticosteroid therapy \> 50% of the year
* Eligible for biotherapy according to the investigator's decision
* Holders of an employment contract for at least 8 days
* Written non-opposition to participate in the study after information
* Social protection affiliation

Exclusion Criteria:

* Existence of another chronic pulmonary disease (bronchiectasis, COPD, diffuse interstitial lung disease, neuromuscular pathology, etc.) or cardiac (cardiac rhythm disorder, ischemic heart disease, etc.) significant according to the investigator's judgment
* Psychiatric disorder
* Pregnancy
* Persons under guardianship
A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department

This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. The study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. Study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.

Routine care patients will have intravenous lines placed in the usual manner.

Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.

Eligibility Criteria:
Inclusion Criteria:

* Ages 4 - 9
* Requiring IV placement for medical care in emergency department
* Child cognitively normal

Exclusion Criteria:

* No significant chronic medical conditions
* No IV in past 3 years
Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions

This study is designed to learn more about children who have blockage of the left side of their heart. The goal is to determine how much the heart muscle has thickened before surgery and how it changes in the months after surgery. Investigators are also looking for blood tests that may help them predict which patients will have the most thickening pre-operatively and the best return towards normal after surgery. The findings of this study will help the investigators develop new tests to monitor affected patients and develop new therapies to help minimize heart thickening.


Eligibility Criteria:
Inclusion Criteria:

* Congenital heart disease patients with the following diagnoses undergoing surgical repair: Coarctation of the aorta (CoA), aortic stenosis (AS), subaortic membrane (sub-AS), supravalvar aortic stenosis (supra-AS).
* All patients will have age from birth through 18 years of age.
* While we will generally not enroll patients with other co-morbid heart disease that would alter the cardiac physiology (see exclusion criteria), patients with patent foramen ovale, atrial septal defect, and patent ductus arteriosus specifically will be allowed.

Exclusion Criteria:

* Patients with lesions not listed in inclusion criteria (including but not limited to hypoplastic left heart syndrome, Shone's complex, mitral valve stenosis or regurgitation greater than trivial, non-restrictive ventricular septal defect, interrupted aortic arch, atrio-ventricular canal defect)
* Corrected gestational age at time of surgery \<34 weeks
* Weight at time of surgery \<2000g.
* Patients who will not be seen for any follow-up care at Children's Hospital Colorado
Electrical Stimulation With Different Currents: the Effects on Force, Tolerance and Fatigue in Healthy Subjects

Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.

If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.

Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.

Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.

Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.

Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.

Purpose:

As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.

Methods:

Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.

The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.

To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.

The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Male
* Right leg dominant
* Exercising regularly

Exclusion Criteria:

* History of injuries in the right leg
* Skin lesions
* Having a pacemaker
* Having a cardiovascular disease.
* Having a neurological disorder.
* Exercise 72 h before the procedure.
Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait

To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.

Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, and electroencephalography (EEG) record.

In the second day after the last treatment, all the tests, MRI and EEG were reassessed. Patients were instructed to focus their answers on the past 1 week.

The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of FOG with expertise in movement disorders.
2. the score of item 3 of the FOG questionnaire ≥1.
3. ongoing treatment with a stable dose of any medication for 2 months.
4. 40 years of age or older.

Exclusion Criteria:

1. a history of addiction, psychiatric disorders, or neurological diseases other than PD.
2. focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
3. anti-PD medication adjustments during rTMS treatment.
4. history of substance abuse within the past 6 months.
5. nonremovable metal objects in or around the head.
6. previously received rTMS treatment.
7. prior history of seizure or history in first-degree relatives.
Resilience Programming for Occupational Therapy Students

The purpose of this study is to explore the effectiveness of integrated health and resiliency programs into the Entry-Level Doctor of Occupational therapy curriculum.

The objectives are to:

1. Determine if students perceive health and resiliency programming as beneficial for their health and well-being
2. Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming
3. Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs

Students will engage in resilience programming as part of their regular coursework and be invited to complete pre and post assessments to test the effectiveness of programming.

University students are experiencing more challenges with anxiety, depression, and mental health. Health and resiliency programs embedded into the 3-year course curriculum may improve student health and wellness.

This study will utilize a quasi-experimental design to explore the effectiveness of health and resilience programming for occupational therapy students while they are enrolled in the program. Pre and post data will be gathered through questionnaires. Additionally, qualitative data will be obtained from student discussion board posts/assignments, interviews or focus groups will be used to supplement the quantitative data.

The purpose of this study is to explore the effectiveness of integrated health and resiliency programs into the Entry-Level Doctor of Occupational Therapy curriculum.

Objectives:

Determine if students perceive health and resiliency programming as beneficial for their health and well-being

Determine if students' lifestyle behaviors, self-esteem, attachment security, and mindfulness improve with health and resiliency programming

Determine if students' symptoms of depression and anxiety reduce after participating in health and resiliency programs

Eligibility Criteria:
Inclusion Criteria:

* students enrolled in the Entry Level Doctor of Occupational Therapy program at Loma Linda University
* Enrolled during June 2023 to June 2029
* Between 18-65 years of age
* Of any gender
* Of any ethnic background

Exclusion Criteria:

* N/A
A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease

The objective of this study is to test a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD). This pilot experiment will involve the collection of both subjective user evaluation measures and objective motor and cognitive measures.

Participants \& Protocol:

Recruitment: Advertising ads in movement disorders units in hospitals and medical centers in the south, as well as through the help of the Parkinson's Association.

The study will be conducted with 15 PD patients, aged 50-75, at the Adi Negev Clinic. Each patient will use the robotic system five times, with each session lasting 30 minutes. The intervention plan incorporates principles of effective rehabilitation practice, including repeated practice, goal-oriented practice, variable difficulty, rhythmic cueing, and social interaction. Before the research begins, participants will sign an informed consent form.

Baseline and Pre-Post Tests:

Assessments including the MoCA, demographic data, clinical data, Color Trails Test (CTT), motor UPDRS, Box \& Blocks Test, and Cognitive Reserve Index Questionnaire (CRIq) will be collected before the first session by an occupational or physical therapist. After the fifth session, post-intervention assessments will include motor UPDRS, Box \& Blocks Test, CTT, System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and a satisfaction questionnaire.

Hypothesis:

It is hypothesized that motor and cognitive training using the robots will improve the patients' clinical symptoms, as evidenced by pre-post test results.

Novelty \& Impact:

This is the first socially assistive robotic platform developed specifically for people with PD. If successful, this platform could be incorporated into the clinical toolbox at Adi Negev and other centres. Additionally, this study will be the first to use the Cognitive Reserve Index Questionnaire (CRIq) in Hebrew for people with PD. The potential impact of this project is twofold: testing a new rehabilitation tool and a screening tool for PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Signing the informed consent form
* Men and women in ages 50-75
* Hebrew speakers
* Have Idiopathic Parkinson's disease
* Hoehn and Yahr 3 and below
* Moca test 23 and above

Exclusion Criteria:

* Patients with Parkinson's plus syndromes
* PD patients who suffer from unrelated neurological symptoms.
* Orthopedic problems of the upper limb
* Recent surgery conducted on the upper limb
* Uncorrected vision problems
* Uncorrected severe hearing loss
Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity

The menisci in the knee joint are important for normal functioning of the knee. Meniscus tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the treatment option ie repair versus partial meniscectomy.

This study aims to identify any changes that occur in the meniscus blood supply. The following are the main aims of the 'MOVE'study-

1. Use of non-invasive methods ie MRImaging to assess meniscus vascularity to preoperatively plan treatment and advice patient on recovery.
2. The study would assess changes in meniscus blood supply depending on age of the patient.
3. The study aims to assess the alteration in meniscus blood supply following an arthroscopic(key hole) meniscal repair operation.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for Group I,II

1. Patients should be aged 18-20 years or 35-45years
2. Asymptomatic knee for past 6 months.
3. Painless flexion-extension movements at knee joint.

Inclusion criteria for Group III

1. Patients should be aged 75 or older
2. Knee X-ray showing no more than Kellgren-Lawrence grade II osteoarthrtis
3. No clinical suspicion of meniscus tear
4. Painless flexion-extension movements at knee joint.

Inclusion criteria for Group IV

1. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair.

Exclusion Criteria:

1. Proven Polyarthritis / Polyarthralgia secondary to Rheumatoid arthritis, Gout, Lupus, Ankylosing Spondylosis, Psoriatic arthritis
2. Any previous surgical procedure(open or arthroscopic) involving the knee joint.(baring the current meniscus repair in Group IV participants)
3. Patients unable to give informed consent.
4. Patients with contraindication for MR Imaging - Metal implants, prosthetic heart valves, pacemakers, metal foreign bodies, VP shunts, pregnancy, cochlear implant, metal clips in the brain, Patients with static tremor i.e. Parkinson's disease.
5. Patients with contraindications for contrast agent - Renal impairment, Previous allergic reaction.
Application of Auriculotherapy on Nursing Professional Stress Levels

Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.

Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were divided in 3 groups (control, needles and seeds).

They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and received 8 sessions through Shenmen, Kidney and Brainstem points.

Eligibility Criteria:
Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress
Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem
* is at least 21 years of age at the time of surgery
* is skeletally mature in the PI's judgment
* has consented to participate in the study by signing the EC approved ICF

Exclusion Criteria:

Patient:

* requires the use of a ceramic-on-ceramic bearing
* has infections, acute or chronic, local or systemic
* has severe muscle, nerve or vascular diseases that endanger the respective limb
* has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis
* has any concomitant disease that may jeopardize implant function
* has a known allergy to study device or one or more of its components
* requires a revision surgery and has extensive bone defects
* has diagnosis of an immunosuppressive disorder
* is pregnant