cyrilzakka/clinical-trials huggingface dataset:
Adolescent, Caregiver, and Young Adult Perspectives of the Transition From Pediatric to Adult Care for Sickle Cell Disease: A Preliminary Evaluation of the Sickle Cell Disease Transition Program

Sickle cell disease (SCD) is a debilitating genetic disorder affecting 70,000-100,000 Americans. It is frequently associated with very serious medical complications. For children with SCD, successfully transitioning to adult care is a vital step in ensuring continuity of care, managing their disease, and improving their health outcomes. Transition programs have been created to facilitate the transition process. However, few studies have assessed transition readiness and whether transition program components meet the transition needs of patients and families.

The purpose of this study is to explore transitioning from pediatric care to adult care and to assess components of the SJCRH SCD Transition Program from three perspectives: adolescents with SCD, their caregivers, and young adults with SCD who have transitioned to adult care. Data collection methods will include focus groups, questionnaires, and checklists. Qualitative data analysis procedures will be used to examine the data.

In this study, through the use of focus groups and questionnaires, we will identify perceptions of transition from pediatric to adult care, transition readiness, disease knowledge, and self-management skills, and assess components of the St. Jude Children's Research Hospital (SJCRH) Sickle Cell Disease Transition Program. Participants will participate in focus groups to discuss transition and transition-related concepts and evaluate components of the transition program. Additionally, participants will complete questionnaires about specific aspects of the transition program and about current disease knowledge and management skills.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with SCD (all genotypes) ages ≥ 12 years old and ≤ 18 years old and currently receiving services through the SJCRH Sickle Cell Disease Transition Program.
* Caregivers who have resided with the adolescent with SCD for at least 2 years prior.
* Young adults with SCD (all genotypes) ages ≥ 18 years old and ≤ 30 years old who have transitioned to adult care

Exclusion Criteria:

* Non-English speakers.
* Adolescents and young adults with sickle cell trait.
The Protein (Meat) and Function Study

The aim of the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, 19-40 y/o

Exclusion Criteria:

* Smokers
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.


Eligibility Criteria:
Inclusion criteria

1. A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

1. Presence of an interfering open wound or edema in the study device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Characterization of Intestinal Microbiota in Children With Inborn Errors of Metabolism (IEM)

Study around children with inborn errors of metabolism (IEM) and their healthy siblings. Collection of stool and urine to assess contribution of microbiota to disease severity.

This study aims to collect biological samples (stool and urine) from children with inborn errors of metabolism, IEM (like UCD (urea cycle disorder), PA (propionic aciduria) and MMA (methylmalonic aciduria) and their healthy siblings.

The main focus of the study is to assess the contribution of the intestinal microbiota to disease severity in children that suffer from different forms of IEM and potentially find microbiota targets that could be used in the design of therapeutic/prophylactic agents.

Eligibility Criteria:
Inclusion Criteria:

* Children or siblings of children that have been diagnosed with one of the following diseases: any type of UCD, PA or MMA

Exclusion Criteria:

* Children or siblings of children that have not been diagnosed with one of the following diseases: any type of UCD, PA or MMA
* use of an investigational drug or device less than 30 days prior to the study, or current enrollment in another investigational drug or device study less than 30 days prior to the study
* considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures, in the opinion of the investigator
Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography

The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler

This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, between 23 and 45 years of age.
2. Willing to sign informed consent

Exclusion Criteria:

1. Currently smoking
2. Any abnormal skin condition in the area of light irradiation.
3. Pregnant having given birth less than 3 months ago, and/or breastfeeding.
4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
5. Having any illness that might affect the vasculature, such as diabetes (type I or II)
6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
BPAP in Pediatric Asthma Pilot Study

The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.

Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP).

The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation
* Prior clinician diagnosis of asthma
* PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen
* Need for continuous nebulized albuterol therapy

Exclusion Criteria:

* Hypercapneic respiratory failure (partial pressure of carbon dioxide \> 60 mmHg)
* Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen \> 0.35)
* Presence of a tracheostomy or baseline noninvasive ventilation requirement
* Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis)
* Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight \< 20kg)
Cluster Randomized Trial of Peer Health Education in Malaria in The Gambia

Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. We incorporated a malaria component to an established peer health education programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and practice (KAP) of school students and their families using a cluster randomized design. Since malaria is a particular problem among children under 5 and pregnant women, students were encouraged to explain what they learned to their families, and we sought to evaluate whether the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in students, and KAP in women living in the school students' home compound.

12 communities in The Gambia, each including an upper basic and/or a senior secondary school, were pair-matched on urban/rural location and school type, and one community in each pair randomly selected to receive the peer-health education programme immediately or after a delay, to permit evaluation. The intervention programme comprised training of peer health educators, teacher coordinators, and members of drama troupes, in key malaria messages and principles of health education. The peer educators then conducted a rolling programme of presentations to children and youth in their own schools using drama, puppetry, small group and in-class presentations about malaria, as well as community outreach programs targeting out-of-school youth and the general public. In each school a systematic sample of 75 students were interviewed 10 weeks and 6 months after the start of the programme, and in each school catchment area a sample of 80 women were interviewed at the same time, and bednet use by children under 5 yrs in their care was recorded. From the interviews scores were derived for knowledge about malaria treatment and prevention and knowledge scores and net coverage in children compared between intervention and control schools.

Eligibility Criteria:
Inclusion Criteria:

* Woman caring for a child under 5 years of age, living in the compound of one of the peer health educators
* Student attending school

Exclusion Criteria:

* Not caring for a child under 5 years (for women)
* Not living in a compound of a peer health educator (for women)
Trunkstability: a Predisposition for Armfunction

Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.

Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength.

Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30
* no orthopedic, neurologic disorder that can influence the reaching
* age between 18 and 70 yrs

Exclusion Criteria:

* BMI\>30
* orthopedic, neurologic disorder that can influence the reaching
* \< 18 yrs of age
* \>70 yrs of age
Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus

Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common risk factors for plantar pain and related disability. The aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic DM patients has with different BMI.


Eligibility Criteria:
Inclusion Criteria:

* having plantar pain
* and no change in BMI by more than 10% for at least 3 months
* being volunteer to participate to the study

Exclusion Criteria:

* having musculoskeletal surgery for foot
* having neurological, orthopedic, and cardiovascular diseases
* vision and hearing problems that may cause balance disorder
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for CVC Insertion Training for Surgical Residents

Human participants will include medical residents and patients. Each year the entering 1st year medical residents at Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform these procedures using the DHRT or the DHRT+ devices. The resident's performance will be measured and evaluated by these devices during the training. The technique of the training does not differ from what is currently taught at either of these institutions. In addition the residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment the residents will perform CVC interventions on under supervision. During this supervision the attending will fill out a short survey about the residents performance. After the procedure the investigators will examine patient files to determine any changes in central line related complications and infection rates due to new clinical educational practices.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing central venous catheterization

Exclusion criteria:

* patient that is not undergoing central venous catheterization
TOTEM: Trial of TAP Block Effective Medications

Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
* English speaking

Exclusion Criteria:

* Known current malignancy
* Contraindication to medications
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

This study represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation.

Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Patients will use the Noona® Healthcare Mobile PRO Application to identify real time select HRQoL and cognitive symptoms. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). Patient engagement with the application will be tracked to determine feasibility.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
2. Initial radiation must have been completed more than 6 months prior to enrollment. Acceptable radiation therapies include fractionated partial brain irradiation, whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) of at least 20 Gy
3. Age ≥ 18 years at the time of entry into the study
4. Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2
5. No imaging evidence of disease progression within 4 months of enrollment
6. Life expectancy \> 6 months per treating neuro-oncology providers
7. Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application
8. Subject must be fluent in English

Exclusion Criteria:

1. Active psychiatric illness
A Community-University Approach to Preventing HIV

Examine the feasibility and acceptability of delivering the S4E intervention to 20 African-American youths between the ages 16-21 in Flint, Michigan. The investigators will examine the preliminary efficacy of the S4E intervention in improving the uptake of HIV self-testing immediately post-intervention.

HIV is a significant public health concern in the US, and African American youth (defined as the adolescent and young adults 16-21 years of age) are disproportionately affected. Furthermore, HIV risk behaviors, including substance use and sexual risk behaviors are prominent. Despite the disproportionately high rates of HIV infection and risk behaviors in youth, few youth report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. To address these significant public health concerns, a mobile-health (mHealth) intervention, Storytelling 4 Empowerment (S4E) was developed for health clinic settings. S4E has demonstrated high feasibility, acceptability, and preliminary efficacy among youth in clinic settings. The proposed research will determine the feasibility and acceptability of delivering S4E via near peers, as well as determine the preliminary efficacy of S4E to improve HIV self-testing immediately post-intervention in a community sample (n=20) of at-risk youth ages 16-21 living in Flint, Michigan by conducting a phase I, one-arm pilot study to examine the feasibility and preliminary efficacy of S4E in improving the uptake of HIV self-testing immediately post-intervention. A University-Community approach was taken to employ principles of Community Based Participatory Research (CBPR) to determine the accessibility and acceptability of S4E when delivered by Near Peers.

Eligibility Criteria:
Inclusion Criteria:

* 16-21 years of age
* Sexually Active
* African American
* Live in Flint Michigan

Exclusion Criteria:

* Report of prior psychiatric hospitalization by adolescent
* Visible cognitive impairment due to drug use
PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial

Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.


Eligibility Criteria:
Inclusion Criteria:

* \>18yrs of age
* Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS \>120ms and significant LV dysfunction LEF \<35%)
* Stable on optimal medical therapy for at least 3 months
* No exclusion to pacing /ICD
* Ischaemic or non-ischaemic aetiology

Exclusion Criteria:

* Any contraindication to pacing /ICD implant
* Contraindication to MR scanning
* Claustrophobia
* Significant renal impairment (estimated GFR \<30)