cyrilzakka/clinical-trials huggingface dataset:
School Climate and Children's Behavioral Health

The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching).

Demonstrating that school personnel can implement evidence based interventions (EBIs) for externalizing and anxiety problems with a high degree of fidelity, integrity and clinical effectiveness could spur more initiatives toward the adoption of EBIs in urban schools, thus further lowering health disparities in these settings. The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching). This study will target six schools within the Philadelphia School District (PSD). Within those 6 schools, research participants will consist of students (grades 4-8) and school staff members. The investigators will evaluate 1) the effectiveness of SWPBS with consultation and coaching, as compared to the baseline and to SWPBS with consultation only; in reducing office discipline referrals (ODRs) and improving school climate, and children's grades, diagnostic status, symptom severity and impairment; 2) the effectiveness of the SWPBS with consultation and coaching, as compared to SWPBS with consultation only, in increasing program fidelity and integrity.

Eligibility Criteria:
Inclusion Criteria:

* All 6 participating schools are included in Tier 1.
* The inclusion criteria for Tier 2 includes children in grades 3-8, who are referred by a school staff member because of behavioral or emotional difficulties or because they have received 3 or more Office Discipline Referrals. Children who consent to participate in the project.

Exclusion Criteria:

* There are no exclusion criteria for Tier 1.
* The exclusion criteria for Tier 2 include any child in grades 3-8 whose family chooses not to consent to screening or participate in the intervention, has Special Education classification of "Intellectual Disability", who is not able to communicate in English, or has a history of psychotic or autistic spectrum disorders.
Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia

Objective: To determine the efficacy of computer-assisted cognitive remediation (CACR) in patients with chronic schizophrenia in the community settings.

Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CACR programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study.

Samples: 80 patients with stable and chronic schizophrenia will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity.

Expected Findings: Find out the training effects of selected CACR on EF and daily functioning in patients with schizophrenia.

Schizophrenia is one of the most serious and disabling mental disorders. Prevalence of schizophrenia is about 1% worldwide. The related dysfunctions have great impact and burden to the concerned person and to the society. With increasing use of CR programmes in helping the patients to resume their capability in community living, the clinical outcome was not fully established especially on specific cognitive domains such as executive function (EF). The present study aims at evaluating the efficacy of CACR on developing EF and improving daily functioning. The result will provide information for therapists' future clinical decisions for patients' best reintegration into the societies. This also helps decrease the burden of family, society in the long run.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, based on Diagnostic and statistical manual of mental disorders (5th ed.), at chronic and stable state
* Age from 18 to 64
* Regular attendance to rehabilitation training programmes
* Willing and capable to participate and are voluntarily consent to the participation
* Pass the cut-off point of referenced screening tests

Exclusion Criteria:

* Comorbid differential diagnosis
* History of organic brain disorder
* Complicated conditions that preclude regular attendance of the training
* Currently receiving computer-assisted cognitive remediation and other individual intensive cognitive training
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female between 18 and 55 years old.
* Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
* Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision \[DSM-IV-TR\]); is able to speak, read, and understand English; and will provide written informed consent.
* Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

Exclusion Criteria:

* History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
* History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
* Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.
Robot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI)

This study will use a socially assistive robot to deliver cognitive training in the form of a music (piano) learning intervention to socially isolated older adults with mild cognitive impairment.

Cognitive training has been shown in past research to improve cognitive function in older adults with and without mild cognitive impairment. Music learning has been previously shown to be a particularly effective form of cognitive training: in addition to the cognitive demands of learning notation, hand positioning, coordination and timing, those who engage in music learning also benefit from emotional connection to the music and social engagement with a music teacher.

Not all older adults are able to access music lessons. Older adults who are homebound, live in rural areas and do not have access to reliable transportation (or a monthly income with sufficient funds for recurring payments for lessons) are unlikely to be able to access these benefits. Socially assistive robots that can deliver both education and companionship on an ongoing basis within the home environment may be a viable solution to these limitations.

The purpose of this study is to deliver cognitive training in the form of a music (piano) learning intervention to older adults who are socially isolated, and who may be able to benefit from the cognitive training aspects of the intervention. A socially assistive robot will deliver the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Be able to speak, read and write in English with a high degree of fluency
* Cumulative music learning experience \< 3 years
* Able to sit upright for two hours at a time
* Able to see images on a screen at a distance of approximately 20 inches
* Must have independent transportation to and from the Institute of Gerontology, weekly, for 27 weeks
* No hearing impairment beyond what is correctable via hearing aid
* Must have a safe location in the home to store and use an 88-key keyboard + stand and piano bench
* No more than mildly cognitively impaired: global deterioration scale no higher than 2-3; Clinical Dementia Rating Scale no higher than 0.5 (sum of boxes)
* Must have a close companion, family member or loved one who can attend the first and last visit
* Must be capable of providing informed consent (based on responses to questions on study purpose, tasks, benefits, incentives and risks).
* Must have a computer or tablet that is connected to broadband internet, to be used three times over the course of the study
* Must have access to an e-mail account that can be checked three times during the study

Exclusion criteria:

* No previous diagnosis of Alzheimer's disease or related dementias
* No condition that limits movement of the hands or fingers
Myobloc Atrophy Study

The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.

Botulinum toxin has long been used as a clinical application for the treatment of overactive skeletal and smooth muscles, i.e. spasticity. The benefits of botulinum therapy are indisputable, however, muscle atrophy is one main adverse effect that may hinder a patient's strength and decrease the ability for the practitioner to accurately administer botulinum toxin to a specific muscle group. This, in turn may cause unintentional weakness of adjacent muscle groups through inaccurate targeting or diffusion of botulinum toxin. Currently, only two serotypes (abbreviated to BTX-A (BOTOX, XEOMIN and DYSPORT) and BTX-B (MYOBLOC), respectively) are used in clinical practice for spasticity. Research has shown that both BTX-A and BTX-B are efficacious in the treatment of spasticity. However, there is no documented literature evaluating if there is a statistically significant difference in the degree of muscle atrophy using BTX-A versus BTX-B.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or older with spasticity secondary to either a disorder or trauma, such as a spinal cord injury (SCI), a brain injury, a tumor, a stroke, multiple sclerosis (MS), or a peripheral nerve injury.
* Participants must have the ability to provide written consent to participate in the study.

Exclusion Criteria:

* Patients who have received BTX-A or BTX-B in the past in the skeletal muscle group under investigation or patients who have had an allergic response to BTX-A or BTX-B in the past.
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis. Females who are pregnant or breastfeeding. Subjects taking Aminoglycosides or other agents interfering with neuromuscular function.
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction (\< 21 days)
* Ejection fraction \<= 40 % or wall motion index \<= 1.3

Exclusion Criteria:

* Implantable loop recorder can't be implanted within 3 weeks after MI
* NYHA class IV
* Planned or previous ICD implantation
* Planned CABG
* Severe valvular disease
* Pregnancy
* Life expectancy \< 1 year for non-cardiac cause
Cardiometabolic Risk of Shiftwork

The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.


Eligibility Criteria:
Inclusion Criteria:

* Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
* Individuals who have been shift workers for less than 10 years; body mass index \<40 kg/m2;
* No major illness
* No history of psychiatric, endocrine, cardiac or sleep disorders
* Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
* Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study.
* Age must be between 18 and 50 years

Exclusion Criteria:

* Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
* Individuals who have been shift workers for more than 10 years
* BMI\>40 kg/m2
* Individuals with a major illness (e.g. diabetes, sleep disorder)
Phase 1 Study for Safety of ACHN-490

This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Within normal weight limits
* In good health with normal routine laboratory results
* Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noise

Exclusion Criteria:

* No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
* No problems with hearing or balance
* No previous injury or surgery the the ears
* No family history of hearing loss before the age of 65
* Not taking any medication other than birth control medication
* Smokers or use of tobacco products
* Recent blood donor
* Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)
Ivermectin Neurotoxicity and ABCB1 Gene Mutations

The study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. The child had inherited from each parent one of the alleles. Each mutation generate a predicted truncated protein that likely lead to ABCB1 loss of function, and the undesirable effects observed.

The study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. The ABCB1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. The child had inherited from each parent one of the alleles. Each mutation generate a predicted truncated protein that likely lead to ABCB1 loss of function, and the undesirable effects observed.

While in some animals, nonsense ABCB1 mutations can lead to neurotoxicity of several ABCB1-substrate drugs, in humans, ivermectin was considered to have an especially high margin of safety, and nonsense mutations have never been reported before, nor has the neurotoxicity of ivermectin apparently caused by these two mutations never been reported before.

This discovery is of critical importance for the child, since it dictates that clinicians would need to optimize any ABCB1 substrate-based therapy in the future. More generally, such information must be brought to the attention of clinicians' medics, and in particular infectious disease specialists, pediatricians, and general practitioners.

It points the importance of pharmacovigilance, and the benefit of pharmacogenomic genotyping in well-defined phenotype, still too rarely considered in clinical practice before the implementation of a drug treatment.

This work results from a multidisciplinary approach, combining several areas of expertise in clinical pediatrics, pharmacology, biology, and bioinformatics.


Eligibility Criteria:
Inclusion Criteria:

* episode of neurotoxicity

Exclusion Criteria:

* NA
Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19

The purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or COVID-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by OCT. Correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. A small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. Following the completion of any such work, residual samples will be stored in a "bio-bank" to enable the completion of future work. Understanding the relationship with symptom-based quality of life scoring questionnaires and a functional assessment of exercise capacity will help elucidate the clinical impact of in-vivo small airways findings.


Eligibility Criteria:
Inclusion Criteria:

1. Age 16 or over
2. Scheduled for bronchoscopy as part of clinical care or research protocol
3. No bleeding diathesis or therapeutic anticoagulation
4. COPD:

   * FEV1/FVC ratio \<70% or

Asthma:

* Diagnosed by standard clinical methods
* Post-bronchodilator FEV1 ≥60% predicted or COVID-19 infection or previous COVID-19 infection (confirmed as per local guidelines)

Exclusion Criteria:

1. Unable to provide informed consent
2. Exacerbation of obstructive airways disease or respiratory infection requiring systemic antibiotics or corticosteroids in the 6 weeks prior to enrolment unless suffering from COVID-19 infection and bronchoscopy is required for clinical reasons
3. Contra-indications to performing lung function testing

   * Aortic aneurysm \>6cm
   * Unstable cardiovascular disease (unstable angina, myocardial infarction or pulmonary embolism \<4 weeks prior)
   * Severe aortic stenosis
   * Pneumothorax
   * Cerebral aneurysm
   * Thoracic or abdominal surgery \<4 weeks prior
4. Contra-indications to passing oesophageal balloons

   * Oesophageal ulceration or varices
   * Sinusitis, recent nasal surgery or epistaxis
Glutathione and Health With Post-Polio Syndrome

In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.

Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures.

After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.

Eligibility Criteria:
Inclusion Criteria:

* Ability to walk 100 feet with usual assistive devices (ex. cane or walker)
* Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity.

Exclusion Criteria:

* Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus)
* Currently taking glutathione or other antioxidants
Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]

We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance

We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention.

We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained

Eligibility Criteria:
Inclusion Criteria:

* Candidates for prosthetic surgery
* Patients of both sexes over 40 years of age
* Hemoglobin values \<12 g% for females and 13 g% for males
* % transferrin saturation \< 10%
* Willingness and ability to provide informed consent.

Exclusion Criteria:

* Patients with Mediterranean anemia
* Patients with coagulation disorders
* Patients who do not sign the consent form
* Pregnant or breastfeeding women (self-declaration)
* Minor aged