cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 2 years to 17 years old
2. Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
3. Patient presents within the first 20 days after fever onset
4. Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
5. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
6. Males engaging in sexual activity that could lead to pregnancy must use a condom.

Exclusion Criteria:

1. Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
2. Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
3. Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
4. Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
5. Patient has a history of allergy to atorvastatin or its derivatives
The Frequency and Risk Factors of Delayed Graft Function

Delayed graft function (DGF) is an important phenomenon after kidney transplantation with direct and indirect implication on graft survival. Although its incidence and risk factors have been studied after cadaveric kidney transplantation cases, only few data is available regarding transplants from living donors. The present study was performed to investigate the frequency and risk factors of DGF among living-unrelated kidney transplant recipients among three transplant centers in part of Middle East.

In this multi-center retrospective study, data from 480 transplanted patients had been collected from existing local hospital registries in three countries (Iran, Kingdom of Saudi Arabia (KSA), and Kuwait) with 3 years post transplantation follow-up. Data for this study was collected based on routine clinical practice of medical practitioners across the participating countries. A case report data collecting form was designed for gathering the data including the recipient and donor's characteristics prior to transplantation, and after transplantation up to three years post transplantation. Using binary logistic regression analysis, the potential risk factors for occurrence of DGF in living donor transplantations were tested. Graft and patient survival at 1, 2 and 3 years depending on follow-up time was evaluated.

Eligibility Criteria:
Inclusion Criteria:

Living donor kidney recipients with complete prior transplantation data and 3 years post transplantation follow up, including those who died during the observation period

Exclusion Criteria:

kidney recipients younger than 18 years
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism

The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional coaching intervention ("Parentship") for parents of adolescents with High Functioning Autism (HFASD).

The "Parentship" protocol is a short-term intervention program in occupational therapy that aims to promote parental resilience and enhance adolescents' participation in daily life.

"Parentship" is a structured occupational therapy intervention for promoting parental resilience and enhance adolescents' participation in daily life The Parentship protocol uses OPC (Graham \& Rodger, 2010) as the primary treatment approach. Its primary goal is to lead parents into recognition and understanding of their adolescent's multi-dimensional personal profile that includes sensorimotor, cognitive-behavioral, and social-communicative and personal factors, as required by the International Classification of Functioning (ICF) model (WHO, 2007).

The intervention will be administered by occupational therapists on an individual (or both parents) basis, once a week, over 3-4 months.

10-15 families will be recruited through community advertising. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.

Adverse events, if occur, will be reported to supervising neurologist and the Helsinki Committee.

Eligibility Criteria:
Inclusion Criteria:

* ASD diagnosed by certified medical practitioner
* parent report regarding barriers to occupational performance/participation
* SP2 or BRIEF-Parent or SSIS scores reflecting at least 1 SD from typical

Exclusion Criteria:

* Diagnoses of severe neurological or psychiatric health condition.
* Instability in pharmacological treatment
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

Exclusion Criteria:

* History of hypersensitivity reaction to gadolinium containing contrast material
* Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
* History of hypersensitivity to any other contrast agent
* Patients with uncorrected hypokalemia
* Pregnant and lactating women
* Patients with severe cardiovascular diseases
* Patients in whom MRI cannot be performed.
FDG-PET in the Diagnosis of Autoimmune Encephalitis

The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is:

•is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autoimmune encephalitis according to clinical criteria
* Brain magnetic resonance imaging performed between clinical presentation and treatment
* Cerebrospinal fluid analysis performed between clinical presentation and treatment
* Brain FDG-PET performed between clinical presentation and treatment
* Autoantibodies testing performed between clinical presentation and treatment

Exclusion Criteria:

* Refusal to give consent for the study
Using Mobile Technology to Reduce Stereotypy

Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may considerably interfere with the child's daily functioning, learning, and social inclusion. As such, stereotypy generally has a negative impact on the child and family's health and quality of life. Several behavioural interventions have been developed to reduce engagement in stereotypy in children with autism spectrum disorders, but the limited number of specialists available, the long waiting lists associated with public health services in Canada, and the high costs of private services have considerably restricted accessibility. One potential solution to the limited availability and high costs of services is using a mobile application to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy. To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e., individualized Stereotypy Treatment Integrated Modules), a mobile application designed to assist parents in reducing stereotypy in children with autism spectrum disorders. Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration of stereotypy, offers suggestions consistent with recommended clinical practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for parents of children with autism spectrum disorders. The results of the study will allow us to determine whether the mobile application may be used to treat this core symptom in children with autism spectrum disorders, which could potentially reduce waiting times and costs of providing health services to this population. By reducing engagement in stereotypy, the iSTIM may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autism spectrum disorders
* Must engage in at least one form of stereotypy

Exclusion Criteria:

* Stereotypy occurs less than 12 times per hour (or less than 20% of time)
* The form of stereotypy is potentially dangerous for the person (e.g., head banging, self-biting)
* The form of stereotypy is maintained by social consequences (e.g., attention, task avoidance)
Nature and Well-Being Project

The investigators pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health.

Neighborhood conditions can positively impact mental health and wellbeing. Green space has been cited as a potential buffer between inequitable neighborhood conditions and poor health. However, there is limited evidence how to increase exposure to green space and how much exposure is needed to produce benefit. Place-based and person-based interventions offer contrasting approaches to improving the impact of the environment on health. The environment influences people as they traverse the spaces between home, work, and recreation, in ways that can be healthy or harmful. Place-based approaches directly change the environment to encourage healthy behaviors, and potentially have broad population impact. Alternatively, person-based approaches directly target individuals' behavior and may be more feasible. To our knowledge, no studies combine both approaches into a single intervention, which may be more effective over either alone.

The broad objectives of this proposal are to pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health. Our place-based intervention, Nature Nooks, builds on our prior greening treatment by adding new features to encourage use - a path and benches to invite people into the space and instillation on large corner lots to maximize visibility. The investigators develop our person-based intervention, Nature Coach, as a novel adoption of an analogous, established patient navigator concept in healthcare.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Live in one of the 8 target neighborhoods identified
* Have a smartphone
* Able to understand and respond to an oral interview in English.

Exclusion Criteria:

* Unwilling to go outside
* Not ambulatory
Evaluation of the Accuracy and Reliability of the Percentage of Glottic Opening Score

Current classifications of the laryngeal view during laryngoscopy are criticized for being subjective.

The modified CL classification is criticized as it does not predict difficult intubation and especially grade 2 is operator dependent and partial view is not well defined. The numerical expression of the percentage of the glottic aperture (POGO = percentile of glottic opening) is another score. In this score, A POGO score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening. Previous validation studies reported on the reliability of POGO; however, accuracy was not evaluated.

The use of a standard and effective classification method will facilitate and accelerate communication between anesthetists in difficult life-threatening situations such as difficult airway / difficult intubation / difficult ventilation and contribute to patient safety. The use of common terminology can also facilitate the evaluation of the performance of intubation tools. The aim of this study was to evaluate the accuracy and intra and inter rater reliability of the POGO score

Reviewer anesthesiologist will be asked to score still images of laryngeal views, which will be obtained from patients requiring intubation for general anesthesia, after obtaining written informed consent. The images of the larynx will be captured first with the Macintosh blade and thereafter with the D blade. An expert panel will score these images with the Cormack Lehane and POGO scores. The set of images will be prepared from patients with both difficult and normal airway anatomy. Some images in the series will be repeated to assess intra rater variability. The anesthesiologist will be asked to rate 20 images both with the CL and POGO scores. The experience of the raters in airway management, their experience with videolaryngoscopy and scoring systems used currently when documenting videolaryngoscopy and demographic data will be also obtained. The POGO scores of the participants and investigators will be compared. The primary outcome measure was the reviewer's agreement with the correct POGO scores (accuracy).

Eligibility Criteria:
Inclusion Criteria:

• Patients receiving general anesthesia

Exclusion Criteria:

• Emergency surgery-
A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers

This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.

The first phase of this study will evaluate the safety and tolerability of BCI-838 following oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite following single oral doses of BCI-838 in healthy male subjects.

The second phase of this study will evaluate and compare the relative bioavailability and PK of the metabolite BCI-632 following single oral administration of several new pro-drug candidates in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Adult male healthy volunteer, 18-55 years of age
* Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
* Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder
* History or current use of alcohol abuse or drug addiction
* Participation in a drug study within 60 days prior to drug administration.
* Participation in more than 3 other drug studies in the 10 months preceding the start of this study
* Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study
* Illness within 5 days prior to drug administration
Base Positioning Wheelchair Hemiplegic

The investigators looked at the population of hemiplegic stroke participants hospitalized with GHIV : the investigators assessed the postural control of the participants of the chair using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The investigators then had to the participants try positioning equipment and then prescribed it once the choice was made. The investigators then reassessed postural control and wheelchair pain with this positioning equipment.

For each hemiplegic participants with wheelchair user stroke, the investigators collect : date of birth, date of stroke, side of hemiplegia. The wheelchair propulsion mode, the degree of autonomy (FAC and Enjalber scales), the way bed - wheelchair transfers are made. Assessment of wheelchair pain in the spine and Ischia with EVA. Time to travel 10 meters in a wheelchair. Postural control of the wheelchair is evaluated by the MCPAA. The investigators then carry out tests of positioning equipment : backrest, cushion, form elements and belt. This material is tried for several days. If it is appropriate (improvement on the postural control and on the pains), otherwise another material is tried.

When the choice is made, the material is prescribed. The participant is seen again 3 months after the delivery of his personal material, and the same evaluation is redone.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia by stroke
* Wheelchair user

Exclusion Criteria:

* Two-handed propulsion of the wheelchair
* Cognitive impairment preventing clinical examination
Could Medical Educational Video Reduce Anxiety Before Nasal Packing Removal After Septoplasty/Septorhinoplasty?

Septoplasty/septorhinoplasty is one of the most common surgical procedures performed in ENT clinics. Intranasal packing is widely used post-operatively for nasal septum stabilization and bleeding control. Patients experience pain after septoplasty during the removal of nasal packing. These patients may be concerned about pain before nasal packing removal, thus increasing anxiety levels. Various methods are currently employed to reduce this pain. Anxiety is a symptom when a person does not feel safe. Anxiety levels can be objectively measured using different tests including Spielberger state anxiety inventory.

In this digital era, there is a growing tendency to use the popular internet sites as YouTube, Google as a new electronic learning for medical information. The quality of information found on YouTube or other sources could be low and make people more anxious before a minor procedure.

Investigators aim to evaluate the effect of visual and auditory information prepared by the surgeon on anxiety level of patient at nasal packing removal after septoplasty/septorhinoplasty. For this purpose; patients who will undergo septo and septorhinoplasty at Istanbul Baskent University Hospital are recruited. A video of nasal packing removal performed by the surgeon will be watched by the patient and Spielberger state anxiety inventory will be filled out before nasal packing removal. The control group will fill out Spielberger State Anxiety Inventory without watching the video before nasal packing removal. The scores of the groups will be compared and the effect of the video based information on anxiety will be revealed.


Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo septoplasty/septorhinoplasty procedures
* patients who will receive nasal packing at their septoplasty septorhinoplasty procedures

Exclusion Criteria:

* patients who will not want to participate to the study
* revision surgeries
* if the patient is taking antidepressants during the last 6 months
* if the patient has a history of a disease that can affect anxiety levels
* if patient wants to be excluded from the study
Effects of Acupuncture on Perceived Stress and Health in Military Service Members

The goal of this is to investigate the effect of a Manual Standardized Stress Acupuncture (MSSA) protocol as an adjunct treatment to a short-term mindfulness therapy for perceived stress and general health in service members (i.e., active duty military personnel and veterans).

The specific aims of this study are Aim 1) To evaluate the effectiveness of a brief MSSA as an adjunct treatment with a short-term Mindfulness-Based Stress Reduction (MBSR) compared with MBSR alone for perceived stress and general health in service members. Aim 2) To describe any perceived benefits of MSSA as an adjunct treatment with MBSR compared with MBSR alone for perceived stress and general health.

Participants will be asked to complete an informed consent if eligible for the study and randomized into two groups: 1) Participants in the experimental group will receive MSSA in addition to MBSR. 2) Participants in the control group will receive MBSR only. Researchers will compare experimental and control groups to see if the interventions mitigated perceived stress and improved the health of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Active duty and veteran service members,
* 18 to 65 years of age, self-report of perceived stress symptoms for at least one month,
* a score of 16 or above on the PSS,
* stable on psychiatric and other medications including blood pressure agents for at least three months,
* agrees to participate in group psychotherapy (i.e., MBSR), and
* able to provide informed consent.

Exclusion Criteria:

* Recent surgery within one month,
* alcohol abuse or dependence diagnosis within one month,
* active substance use/abuse/dependency treatment within one month,
* pregnant women (acupuncture can result in an induction of labor and spontaneous abortion on rare occasions), and
* has had acupuncture treatment, dry needling, and MBSR provided by a provider in the past month.