cyrilzakka/clinical-trials huggingface dataset:
A Cognitive Bias Modification RCT for Aggression

This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.

The objective of the proposed study is to test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with Intermittent Explosive Disorder, a disorder characterized by habitual engagement in aggressive behavior. Efficacy of the CBM program will be assessed via a small randomized controlled trial comparing CBM to a computerized control condition. This training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words \[attention bias\], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations \[interpretive bias\]. Participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study
* Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc.
* Have written and verbal English proficiency for understanding consent and study materials

Exclusion Criteria:

* Have a lifetime history of psychosis
* Have current moderate to severe substance use disorder
* Have a history of bipolar disorder
* Have current major depressive disorder
* Are younger than 18 or older than 55 years old
* Are currently (past month) receiving treatment for anger or aggression
* Recently (past month) started or changed psychotropic medications
Evaluation and Treatment of Patients With Dermatologic Diseases

This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients' diagnosis, response to treatment, and/or disease progression.

Background

This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. This protocol was developed to allow subject enrollment for teaching purposes and to allow for second opinions regarding relatively complicated patients, and to allow for evaluation of non-invasive tools for the diagnosis and monitoring of cutaneous manifestations. This protocol promotes a critical link between the NCI, CCR Dermatology Branch and the local and national extramural medical communities.

Objectives:

* To provide clinical material to fulfill the educational mission of the Dermatology Branch.
* To learn about the natural history of selected dermatologic diseases.

Eligibility:

All subjects regardless of age, gender, or racial/ethnic group with dermatologic disease or systemic disease with cutaneous manifestations.

Design:

Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients diagnosis, response to treatment, and/or disease progression. Non-invasive tools may be used as part of the examination and assessment of cutaneous manifestations of disease.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients of any age (only viable neonates will enroll in the study), of both genders, and all racial/ethnic groups with dermatologic diseases or systemic diseases with cutaneous manifestations that will help the Branch fulfill the objectives.

Women who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child.

Patients must have a referring physician who will continue to assume primary medical responsibility of care for the patient during and after enrollment in this protocol.

EXCLUSION CRITERIA:

Any participant who, in the investigator s opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk.
Impact of CRISP on Self-Efficacy, Loneliness, and Depression

The purpose of this study is to examine the effects of an innovative program, entitled CRISP (Community Integration for Socially Isolated Patients), on improving self-efficacy and assessing whether improved self-efficacy helps to reduce depression and loneliness of people with MS.

Whether CRISP increases self-efficacy while decreasing loneliness and depression

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old.
* Must have a definitive diagnosis of MS by a physician.
* Must understand English at 6th grade level since the CRISP program requires participants to comprehend the educational information presented in English.
* Agree to participate in 12 group sessions over 12 weeks;
* Must have the ability to complete questionnaires in English since the outcome measures used for the study are in English.
* Must be able to commute to the site destinations

Exclusion Criteria:

* Have an actively psychotic Axis I disorder.
* Have a significant Axis II disorder of borderline personality disorder or schizoid personality disorder.
* Have a diagnosis of another neurological condition aside from MS.
* Inability to comply with study requirements/visits.
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients

This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.

A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.

Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Eligibility Criteria:
Key Eligibility Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity
* No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy
* Acceptable laboratory results as indicated by protocol
* Acceptable cardiac function as indicated by protocol

Key Exclusion Criteria:

* Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
* Family history of long corrected QT interval (QTc) syndrome
* Symptomatic central nervous system (CNS) lesions
* Radiation therapy within 2 weeks prior to the first dose of study medication
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
* Concurrent active malignancy requiring systemic treatment
* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus \[HIV\]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
* Pregnant or breast-feeding
Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis

The purpose of this study is to determine whether the addition of Biofeedback-Assisted Relaxation to standard medication treatment improves outcomes for children with a specific type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).

Recurrent abdominal pain (RAP) is the most common type of pain in school age children and young adolescents. Previous studies suggest that stress plays an important role in the activation of specific cells that can produce pain within the stomach and intestines. Medication is the standard approach to the treatment of RAP in children. Although medication is helpful for many children, medication alone is not always enough. Biofeedback trains individuals to use relaxation strategies effectively to relieve emotional and physical symptoms, and has been used successfully for stress and pain reduction with both children and adults. It has shown promising results when used alone in the treatment of children with RAP. Research is needed, however, to determine whether biofeedback training is helpful when used in conjunction with medication. Information about how biofeedback training affects the central nervous system and the cells that produce pain also would be useful in refining treatments for this large group of children. The current research will be done in three steps, with Phase 1 designed to evaluate the time, resources, technical support, and sample size needed for successful completion of the full research study. Twenty children (ages 8-18) with eosinophilic duodenitis, a specific form of RAP, will be enrolled and randomly assigned to one of two groups: 1) Standard of Care; or 2) Biofeedback (standard medical care plus 10 sessions of biofeedback training). Measures of pain, functional disability, quality of life, physiological arousal, and global treatment response will be collected pre- and post-intervention, as well as 3 and 6 months later. Data collected will be used to determine how many participants will be needed for the full research study. If biofeedback training is ultimately found to be a positive addition to standard medical treatment, this could lead to improved health outcomes for children with RAP. This information also could result in greater treatment efficiency and reduced health care costs for families, insurance providers, and the hospital system.

Eligibility Criteria:
Inclusion Criteria:

* A current diagnosis of eosinophilic duodenitis per biopsy.
* Ability to participate in the biofeedback training protocol.
* Transportation available to attend twice weekly visits to Children's Mercy Hospital (CMH).

Exclusion Criteria:

* Previous biofeedback training.
* Previous failure of medications used as standard of care in this study.
* Allergy to medications prescribed in this study.
* Co-morbid chronic illness requiring regular medical care.
Assessment of Tele-expertise for the Interpretation of MRI Among Neonates With High Risk of Neurological Sequelae

The purpose of the study is to determine whether tele-expertise would be more effective and more cost-effective for the Interpretation of MRI Among Neonates with high risk of neurological sequelae


Eligibility Criteria:
Inclusion Criteria:

* Less than 28 days of life
* Mandatory to have a medical advice in paediatric neuroradiology for interpretation of brain MRI

Exclusion Criteria:

* None
Immunogenicity of the Booster Dose of Two MenC Vaccines

The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.

Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.

Eligibility Criteria:
Inclusion Criteria:

* Healthy toddlers of both sexes
* Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
* Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
* Informed consent signed by one or both parents who are adequately informed about the study.

Exclusion Criteria:

* Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
* Toddlers with severe chronic diseases
* Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
* Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
* Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
* Toddlers with personal history of convulsions.
* Toddlers with known bleeding disorder no controlled
* Toddlers with known congenital or acquired immunodeficiency
* Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
* A toddler that under investigator opinion is probable to be lost during the follow-up
* A toddler that is currently included or is planned to be included in any other clinical trial.
* A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
Pilates Mat Versus Cervical Stabilization Exercises on Myoelectric Activity of Cervical Muscles in Forward Head Posture

see if there is no statistical significant difference between the effects of Pilates mat versus cervical stabilization exercises on myoelectric activity of cervical muscles in young adults with forward head posture.

Forward head posture (FHP) increases extension of the atlanto-occipital joint and the upper cervical vertebrae as well as flexion of the lower cervical and upper thoracic vertebrae. Furthermore, this posture causes persistent and abnormal contraction of the suboccipital, neck, and shoulder muscles. Additionally, the muscles around the head and shoulders, including the trapezius, sternocleidomastoid, suboccipital, and temporal, are affected by FHP, which further worsens postural deformity. FHP is the most common deviation from ideal head posture and is characterized by the head projecting forward into the sagittal plane such that it is anterior to the trunk. Head in forward posture can add up to thirty pounds of abnormal leverage on the cervical spine, which pull the entire spine out of alignment, in addition, loss of the physiological lordosis could be a possible cause of pain due to muscular imbalance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders aged 18-25 years old with forward head posture will be included in this study
* Subjects have forward head posture if craniovertebral angle ≤ 50.
* Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months.
* Normal body mass index

Exclusion Criteria:

* Subjects with any spinal problems
* Subjects with experience in Pilates exercises through the last 3 months of the start of intervention will be excluded from the study
* Previous surgery in the neck and shoulder regions
* Current participation in a structured exercises program
* Neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
* Red flags suggesting of cancer, infection, vascular insufficiency
* Cervical radiculopathy or myelopathy
Central Executive Training for ADHD

Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current project is to develop and assess the feasibility, acceptability, engagement, and usability of a novel, central executive (CE) working memory training intervention.

The goal of the core study is to develop a central executive training (CET) intervention for children with attention-deficit/hyperactivity disorder (ADHD) and examine its feasibility, acceptability, engagement, and usability. This will involve early developmental work on software and treatment manuals followed by evaluation of the feasibility of enrolling, retaining, and treating ADHD children with CET. An evidence-informed intervention targeting central executive functioning in children with ADHD has the potential to result in clinically significant improvements in ADHD symptoms relative to extant behavioral treatments and capacity-based (short-term memory) training interventions. The long-term goal is to develop an efficacious and acceptable CET intervention with the potential for generalized improvements in, or normalization of, ADHD-related impairments in peer, family, and academic functioning.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-12 with principal ADHD diagnoses (via K-SADS)
* parent Behavior Assessment System for Children (BASC) Attention Problems or Hyperactivity subscale or ADHD-5 in clinical/borderline range based on age and gender
* teacher BASC Attention Problems or Hyperactivity subscale or ADHD-5 scale in clinical/borderline range based on age and gender.

Exclusion Criteria:

* gross neurological, sensory, or motor impairment, history of a seizure disorder, or psychosis, bipolar disorders, substance use, or intellectual disability disorders
* non-English speaking child or parent
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.

HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

A prospective study will be conducted on 80 patients with an inserted invasive intraparenchymal ICP monitor. Once a patient undergoes invasive ICP monitoring, has a life expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and has an intact/continuous dura layer, the patient will become a candidate for enrollment into the study. If the patient signs the informed consent or the patient's legal authorized representative signs on the patient's behalf, the patient will be enrolled into the trial. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's device. Once the data collection is complete, results will be analyzed by comparing ICP readings from both devices.

The primary end-point of the study is to collect 60-120 minutes of ICP monitoring data over two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. The secondary endpoint of this study is evaluate the safety of the device as measured by incidence of adverse events and serious adverse events over each subject's 96 hours of participation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged 14 years old and over at screening visit
* Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology
* Survival expectancy greater than 48 hours
* Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
* Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

* Subject with ear disease, ear trauma
* Subject with a punctured or discontinuous dura layer (must be intact)
* Subject with cerebral fluid (CSF) leakage
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g. mental condition)
A Three Month Bleeding-Model Clinical Study

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with 10-70% bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.
Tai Chi for Chronic Non-specific Neck Pain

In this study the efficacy of Tai Chi will be tested in comparison to conventional neck exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life, wellbeing, stress perception, psychological distress will be used to determine effects.

see above

Eligibility Criteria:
Inclusion Criteria:

* chronic non specific neck pain (3 months at least)
* 45mm pain intensity on average on the visual analog scale

Exclusion Criteria:

* specific neck pain due to
* inflammatory diseases
* rheumatic diseases
* neurological diseases
* prolapse or protrusion
* oncological disease
* trauma (whiplash)
* congenital deformity of the spine
* severe comorbidity (somatic, psychiatric)
* pregnancy
* participation in other clinical trials
* regular practice of tai chi, qigong, yoga in the past 6 months
* medication with opioids