cyrilzakka/clinical-trials huggingface dataset:
USC and Bodyport Remote Heart Failure Management Study

A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC

Heart failure is a debilitating disease associated with high hospitalization rates which could potentially be curbed by remote patient monitoring. Remote monitoring may allow for the early detection of signs and symptoms of cardiac decompensation, enabling prompt interventions to reduce hospital admission rates or the duration of inpatient stay, and the quality of life of those suffering from heart failure. Recent studies have demonstrated that structured remote patient management interventions can reduce the percentage of days lost to unplanned cardiovascular admissions. The investigators propose assessing the feasibility of a structured virtual cardiac care service leveraging the Bodyport platform to optimize outpatient management of heart failure.

This study will leverage the Bodyport virtual cardiac clinic platform to deliver care for the heart failure patient population at Keck Medical Center of USC. Patients randomized to the intervention arm will receive the Bodyport Cardiac Scale for home monitoring as well as heart failure education and non-clinical support from Bodyport coaches. Daily measurement uploads from the patients will be analyzed and changes in measurement data will be used to guide follow-up and care management, such as diuretic dose adjustments. For this initial feasibility study, the investigators will be focusing on patient and provider satisfaction of the virtual cardiac clinic along with the operational ease of executing this form of care compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HFrEF or HFpEF and hospital discharge for a heart failure exacerbation within 14 days of enrollment.
* 18 years of age or older
* English speaking
* Able to safely stand on the Bodyport scale
* Patients must have a reliable and working phone for communication with the care team
* All patients should have access to the internet via a computer or mobile device to access the Bodyport care platform
* Patients must have a safe and secure place to store the Bodyport device

Exclusion Criteria:

* Weight \>375 lbs.
* History of repeatedly missing follow-up appointments or being unreachable by phone
* Inability to stand on the Bodyport scale for the duration needed to capture data
* Patient in jail or currently homeless
* Known or documented noncompliance with medical therapy
* Unable to speak English
* Unable or unwilling to answer survey questions
* History of heart transplantation
* Chronic kidney disease stage IV or V and/or on hemodialysis
* Presence of a ventricular assist device
* Presence of a CardioMEMs pulmonary artery sensor
Implementing Behavioral Sleep Intervention in Urban Primary Care

Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.

Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. We will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-intervention assessments.Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.

Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this open trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any pre- to post-intervention change in child sleep.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver participant is the parent or legal guardian of the child subject.
* Caregiver/legal guardian 18 years of age.
* Child between the ages of 1 and 5 years.
* Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item, included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
* English-speaking.

Exclusion Criteria:

* Caregiver is not parent or legal guardian of child participant.
* Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep.
* Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Optimization of Exhaled Biomarker Collection and Analysis

This is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. The goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

Exhaled breath has three fractions - gaseous breath, volatile breath, and breath condensate. Biomarkers have been identified in each of these fractions and non-invasive collection methods have been developed. Exhaled breath can be safely and easily performed in all patient populations, including neonatal children and the elderly. We have shown that relative to normal controls, condensed exhalates obtained from asthmatic subjects reproducibly contain elevated concentrations of oxides of nitrogen and are more acidic (having hydrogen ion concentrations two to three log orders higher). We wish to extend these studies across all breath fractions and other lung diseases and respiratory processes including viral upper respiratory tract infections, cystic fibrosis, pneumonia, pulmonary hypertension, bronchiolitis obliterans, chronic obstructive pulmonary disease, tracheostomized patients and cigarette smokers. Through this study extension, we will obtain pilot data/preliminary information about the potential utility of this new technique to non-invasively evaluate disease status in various respiratory diseases. We also wish to obtain data regarding specificity by evaluating the exhaled breath obtained from patients with non-respiratory illnesses, such as, but not limited to diabetes, gastroenteritis, and various inflammatory disorders. We think it is likely that the exhaled biomarkers reflect underlying airway inflammation and infection.

Following informed consent, exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask. Exhaled breath will be diverted into a collection device, which may include a bag, tube, or other device with minimal resistance. The collection process, including completing forms, will not exceed 30 minutes.

Subjects may be asked to provide several specimens during the course of their inpatient stay or clinic visit to obtain longitudinal data.

At no time will the patients be breathing anything other than ambient air with or without oxygen enrichment as clinically indicated. Inhaled air will not be manipulated.

Exhaled breath collection technique is completely comfortable, causing neither discomfort nor fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Study sample will consist of individuals aged 4-110 with a diagnosis of acute or chronic respiratory disorders, or metabolic or systemic conditions involving diffuse inflammation, or normal subjects with no pulmonary disease.

Exclusion Criteria:

* Subjects that are unable or unwilling to cooperate with specimen collection.
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy

Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties.

This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.


Eligibility Criteria:
Inclusion Criteria:

Subjects Receiving Chemotherapy:

* Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade\* lymphoma (\*defined by the treating physician)
* Be scheduled to begin a course of chemotherapy
* Oral chemotherapy is acceptable
* Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible).
* Be chemotherapy naïve
* Life expectancy greater than 10 months
* Be able to speak and read English
* Give written informed consent

Inclusion Criteria, Controls:

* Must be the same gender as the subject receiving chemotherapy
* Must be within 5 years of the age of the subject receiving chemotherapy
* Life expectancy greater than 10 months
* Be able to speak and read English
* Give written informed consent
* Must be willing to participate in the study for the entire period

Inclusion Criteria, Long-Term Followup Study:

* Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3.

Exclusion Criteria:

Subjects Receiving Chemotherapy:

* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
* Must not be diagnosed with a neurodegenerative disease
* Must not have primary central nervous system (CNS) disease
* Must not have received chemotherapy in the past
* Must not be scheduled to receive concurrent radiation treatment
* Must not have metastatic disease (subjects with breast cancer)
* Must not be pregnant
* Must not be colorblind

Exclusion Criteria, Controls:

* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
* Must not be diagnosed with a neurodegenerative disease
* Must not have primary CNS disease
* Must not have been diagnosed with cancer or previously have received chemotherapy
* Must not be pregnant or plan on becoming pregnant during the study period
* Must not be colorblind

Exclusion Criteria, Long-Term Followup Study:

* Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
* Must not be colorblind
An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)

This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent.
3. Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
4. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
5. Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
6. Participants with a body weight of ≥ 40 kg.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with a draining fistula count of ≥20 at the Screening Visit.
3. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
4. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
5. Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
6. Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
7. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder

• to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints


Eligibility Criteria:
Inclusion Criteria:

* • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during opening. iii. TMJ tenderness.

  * Fully dentate patients without any malocclusion (natural or restored by fixed prothesis) and good oral hygiene.
  * Co-operative patient that should show motivation to follow up.

Exclusion Criteria:

* • Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.

  * Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
  * Patients with removable dental prosthesis
Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

Patients who underwent pulsed radiofrequency (PRF) treatment of the posterior tibial nerve under ultrasound guidance, which is routinely performed in our clinic for severe heel pain following a calcaneal fracture, were evaluated through interviews. The assessment was conducted using the Visual Analog Scale (VAS) for pain and the American Orthopaedic Foot and Ankle Society (AOFAS) score.

Pain following a calcaneal fracture can arise from direct injury, traction injury, idiopathic mechanisms such as reflex sympathetic dystrophy/complex regional pain syndrome (CRPS), or nerve damage. Since there is no single standardized definition or diagnosis for post-surgical nerve pain, such cases are described in the literature as neurapraxia, postoperative neuroma, unexplained heel pain, hypersensitive scar, or CRPS. Typically, this type of pain manifests as burning, paresthesia, dysesthesia, and hyperesthesia.

The tibial nerve plays a crucial role in the sensory and motor innervation of the heel. Following a calcaneal fracture, direct nerve injury, compression, or inflammation of the surrounding tissues may contribute to pain. Pulsed radiofrequency (PRF) has been shown to alleviate chronic pain by delivering an electrical field to the nerve tissue at a controlled temperature of \<42°C without causing nerve damage. Additionally, there is evidence supporting PRF's effectiveness in pain relief for patients with various chronic conditions.

In our study, the investigators aim to evaluate patients with persistent pain after a calcaneal fracture who have undergone PRF treatment of the posterior tibial nerve. By monitoring these patients immediately after the intervention, we will assess changes in their pain scores. Additionally, the investigators will compare them to patients with post-calcaneal fracture pain who have opted not to undergo the procedure.

Eligibility Criteria:
Inclusion Criteria:

* History of calcaneal fracture
* VAS score \>5
* Pain persisting for more than 3 months after the fracture

Exclusion Criteria:

* Presence of other foot pain-causing conditions (e.g., plantar fasciitis, heel spur)
* Additional fractures other than the calcaneus
* Pregnancy
* Coagulopathy or use of antiplatelet medications
* Mental illness impairing decision-making ability
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke

The aim of the study is to compare the effects of specific functional task-oriented motor imagery training combined with the Bobath Therapeutic Approach and physical practice after imagery on upper extremity motor function in stroke patients.

Motor imagery (MI) is the mental rehearsal of motor abilities to improve function. Thus, imagery provides both the learning of the new movement and the improvement of the quality of movement by repeating the known activities.the investigators These neurophysiological findings obtained in recent years have popularized the use of motor imagery approach in the rehabilitation of stroke patients.

32 stroke patients aged 50-75 years will be included in the study. Cases will be randomized into 2 groups.

In our study, a treatment program will be applied with a physiotherapist for a total of 8 weeks, 2 days a week. The first group in the treatment program; Motor imagery will be performed with the Bobath Therapeutic Approach (BTA+MI) and the second group will be physical practice of imagery activities after motor imagery with the Bobath Therapeutic Approach (BTA+MI+PP). Motor imagery activity was determined as 'eating activity'.

The desired goal as a result of our work; the investigators think that motor imagery training on eating activity of stroke patients and physical practice used together will improve both the achievement of eating activity and upper extremity motor function.

Eligibility Criteria:
Inclusion Criteria:

* A maximum of 24 months have passed since the stroke,
* Unilateral involvement,
* Getting a score of 21 and above in the Mini Mental Test,
* Getting a score of 22 and above in the Fugl-Meyer Test,
* Ability to understand and follow simple verbal commands,
* Stage 4 or 5 according to Brunnstrom Upper Extremity Stages,
* Spasticity 1 or 1+ according to the Modified Ashworth Scale,
* Having signed the Informed Consent Form.

Exclusion Criteria:

* Patients with visual and hearing impairments that would interfere with work.
* Having pain and limitation of joint movement that may prevent performing the given tasks.
* Having any neurological disorder other than stroke.
Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. Leveraging our presence in the Seattle/Puget Sound area with Everett Clinic, we intend to develop a model that can screen a large number of patients at varying levels of risk and manifestation of clinical symptoms while conserving personal protective equipment (PPE) and decreasing transmission risk to health care workers. This will also serve to support the enterprise and public health response. Towards this goal, we must first assess the equivalence between clinician-collected nasopharyngeal (NP) samples to patient-collected tongue, nasal, and mid-turbinate (MT) samples to detect SARS-CoV-2 across a broad cross-section of the population.

Eligibility Criteria:
Inclusion Criteria:

* Able to consent and agree to participate in the project after discussing the project
* Coming to The Everett Clinic during the operational project duration
* Evidence of upper respiratory symptoms suggesting higher risk of testing positive for SARS-CoV-2 virus.

Exclusion Criteria:

* Not able to demonstrate understanding of the study
* Not willing to commit to having all four samples collected
* Medical history evidencing any of the following

  * Active nosebleed in the past 24 hours
  * Nasal surgery in the past two weeks
  * Chemotherapy treatment with low platelet and low white blood cell counts
  * Acute facial trauma
C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients

The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypercholesteremia who was never treated with statins before
* Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR

Exclusion Criteria:

* None
Anti-VEGF in Real-world

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
* Undergo intravitreal anti-VEGF therapy

Exclusion Criteria:

* unable to receive OCT examination
* Severe corneal opacity, cataract that affect OCT examination