cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who participated in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study Screening Visit.
* Satisfactory completion of the core study in the opinion of the investigator and the sponsor.
* Subjects who are \>18 to ≤35 years of age at the time of screening and did not participate in one of the core studies may be eligible for participation.
* A documented medical history to support a clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely controlled by current antiepileptic drugs.
* Parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.
* Subject's parent/caregiver has been compliant with diary completion during the core study, in the opinion of the investigator (eg, at least 90% compliant).

Key Exclusion Criteria:

* Current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke.
* Current cardiac valvulopathy or pulmonary hypertension that is clinically significant and warrants discontinuation of study medication.
* Current or past history of glaucoma.
* Moderate or severe hepatic impairment.
* Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates.
* Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy.
* A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness at Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Effectiveness of CBT and APT on Managing Child Anxiety in Dental Office

This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office.

This study is to:

1. Assess and compare the effect of cognitive behavioral therapy and auricular plaster therapy on children's anxiety in dental situations.
2. Improve child behavior and cooperation and evaluate the parental acceptance of these behavioral management techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children (4-7) years old, without systemic, congenital, or mental disorders nor deformities affecting the external auditory meatus.
2. Presence of dental anxiety.
3. Not requiring urgent dental treatment, with the presence of a Class I carious lesion on one of the primary molars.
4. No previous application of the guided CBT.

Exclusion Criteria:

1. Refusal to participate by either the children or their parents/guardians
2. Previous receiving acupuncture and moxibustion therapy.
3. Children who had taken sedative drugs at the time of the appointment.
Personal Resilience Empowerment Program Study

The Personal Resilience Empowerment Program (PREP) at Hackensack Meridian Integrative Health \& Medicine was designed in Legacy Meridian to assist all selected patients with upcoming hospitalization. For the "Personal Resilience Empowerment Program (PREP) in the perioperative setting of surgically treated cancer patients", hereafter "the Project or PREP", the Hackensack Meridian Integrative Health \& Medicine is designing a new pilot program to focus on the needs of oncology patients.

All patients diagnosed with cancer that will undergo a scheduled surgical (Hepato-Biliary, and Thoracic) procedure in Hackensack Meridian Health and specifically in the Jersey Shore University Medical Center, will be eligible to participate (for more details please see eligibility criteria, section 4).

Overall, this pilot project will include 5 coaching sessions and an introductory session/visit that will take place on the physician's office. The initial physician visit will focus on patient eligibility, introduction to the Project, informed consent and a pre-intervention survey and will be conducted by the principal investigator or one of the sub-investigators listed above. The following 5 sessions will be conducted by one of the integrative health coaches/registered nurses (for details please see section 5). A post-intervention survey will be completed during the final session and repeated at one month, and at 3 months from the final session.

The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed with cancer would result in improving various metrics including improvements to resilience, sleep, activity, purpose, nutrition, empowerment to manage one's own health and well-being, decrease in pain medication use and more rapid return to previous functional status according to Eastern Cooperative Oncology Group (ECOG).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system (cholangiocarcinoma, pancreatic, liver) that will undergo a scheduled surgical procedure
* Able to understand and sign the informed consent form
* Willingness to participate in the study and comply with protocol requirements

Exclusion Criteria:

* Unable to provide consent
* Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG \>1). See section 5 and appendix 1 for details.
* Non- English speaking patients .
* Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer.
Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases

Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.

Most cases of severe visual loss in developed countries are due to retinal diseases affecting a specialized class of neurons, the photoreceptors. Currently available systems for retinal imaging in humans do not allow neuronal imaging at the cellular level, which is crucial to understand, diagnose and monitor retinal diseases. In recent years, adaptive optics (AO) fundus imaging has proven its capability to image individual photoreceptor cells in the human retina. This technology is now reaching technical maturation. A prototypic AO system (manufactured by Imagine Eyes) is currently in operation in a clinical setting (Clinical Investigation Center 503) and has proven its reliability to monitor single photoreceptors over time. Yet, the clinical evaluation of AO imaging is still in its infancy, and biomarkers issued from AO imaging have not been validated. The goal of the iPhot project is thus to optimize the process of AO imaging (from the implementation of novel technical solution to image processing and data analysis) in order to obtain morphological, quantitative and longitudinal information concerning retinal microstructures in humans. For instance, we will aim at detecting early photoreceptor damage during retinal dystrophies.

Eligibility Criteria:
Inclusion Criteria:

* over 10 years old

Exclusion Criteria:

* ocular media opacities, unstable fixation
Ablation Confirmation Study

Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.

Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin.

All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Eligibility Criteria:
Inclusion Criteria:

1. A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure.
2. Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
3. Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
4. Patients greater than or equal to 22 years of age
5. Performance status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]) classification
6. Class A or B functional hepatic reserve based on the Child-Pugh score.
7. Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).

Exclusion Criteria:

1. Active bacterial infection or fungal infection on the day of the ablation.
2. Patients with implantable pacemakers or other electronic implants.
3. Platelet count less than 50,000/mm cubed.
4. Patients with uncorrectable coagulopathy at the time of ablation.
5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
6. Physical or psychological condition which would impair study participation.
7. ASA (American Society of Anesthesiologists) score of great or equal to 4.
8. Use of hydrodissection.
9. Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
10. INR greater than 1.8.
11. Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
12. Patient judged unsuitable for study participation by the performing physician for any other reason.
Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

This is a randomized, controlled study to compare patients evaluated and managed by internal medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist when they are admitted to the hospital, aiming to demonstrate that hospital admissions for cellulitis that involve early dermatology consultation will reduce hospital length of stay, readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis of this study is that obtaining inpatient dermatology consultations, within 24 hours of a patient being admitted to the hospital for cellulitis, will reduce the length of stay, readmission rate, cost, and antibiotic usage of the patient"s admission as well as properly evaluate and diagnose patients with pseudocellulitis. The primary objective will be to measure the difference in the length of stay for patients who are randomized to a dermatology consultation within 24 hours of hospital admission (active arm) versus being managed by an internal medicine hospitalist alone, as is the standard of care (control arm). The length of stay for each arm will be assessed once the study has been completed. The secondary endpoint will be to measure readmission rates for cellulitis after patients are discharged from the hospital. An additional endpoint will be to determine if antibiotic usage differs between patients randomized to a dermatology consultation and those not. Exploratory analyses will assess the percentage of patients with a concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the association of fever \>100.5 F and a history of a prior episode of cellulitis.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign informed consent
* Able to complete study and comply with study procedures
* Presumed clinical diagnosis of cellulitis by medicine team

Exclusion Criteria:

* Have a known postoperative site infection or abscess
* Have a human/animal bite
* Have known osteomyelitis
* Have a hardware/line infection
* Are under the age of 18
* Have a history of transplantation less than six months after initial transplant and/or if they have had an episode of acute rejection in the last 90 days
* Known use of antithymocyte globulin or campath in the last 6 months or more than 20 mg/day of prednisone for more than 30 days -
* Are a known prisoner.
* Are decisionally-impaired.
* Have abnormal vital signs defined as systolic blood pressure \<90 mmHg, diastolic blood pressure \<80 mmHg, heart rate greater than 90 beats per minute or less than 50 beats per minute, respiratory rate greater than 20, or temperature \> 100.5 F.
* Are known to be pregnant.
Targeting Microbiota in Female Overactive Bladder Syndrome

The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.


Eligibility Criteria:
Inclusion Criteria (case group):

* symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia)

Exclusion Criteria (case group):

* Pregnant or lactating females

  * Neurological conditions (such as MS, Parkinson, spinal cord injury, stroke..)
  * Pelvic Organ Prolapse (stage ≥ 3)
  * Lower Urinary Tract surgery within past 6 months
  * Known history of interstitial cystitis or pain associated with OAB
  * Recurrent urinary tract infections \> 3/year
  * Acute urinary tract infection
  * Urinary retention (with or without required self- catheterization)
  * Stress urinary incontinence or mixed urinary incontinence
  * Bladder cancer
  * Renal insufficiency
  * Urinary tract stones

Inclusion Criteria (control group):

without symptoms of overactive bladder or any other form of lower urinary tract symptoms

* Age-matched to case group (+/- 5 years)
* BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I)

Exclusion criteria (control group):

As case group plus any form of lower urinary tract symptoms including OAB
Effects of Coordinated Care for Disabled Medicaid Recipients

The purpose of this study is to improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. Although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the right doctors, helping them make and keep appointments, and helping them comply with medical or dietary recommendations. To understand the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and disabled Medicaid recipients in the Denver area.


Eligibility Criteria:
Inclusion Criteria:

* Disabled, in fee-for-service Medicaid

Exclusion Criteria:

* Under age 18, over age 64
Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome

OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and QRS morphology/duration, across clinical stages in patients with Rett syndrome.

II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess arrhythmias, heart rate variability, and autonomic nervous system function in these patients using 24-hour Holter monitoring.

IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and polygraph monitoring in patients who have more than 1 clinical seizure every 5 days.

V. Characterize these events with respect to clinical manifestations, EEG correlates, and other physiologic data.

VI. Determine the frequency of seizures vs. events without electrographic correlates in these patients.

VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures and/or an epileptic syndrome.

PROTOCOL OUTLINE: Patients receive an electrocardiogram at baseline and every 6 months for 3 years. Clinical stage II patients undergo 24-hour Holter monitoring on the same schedule; age-matched controls are tested once.

A group of patients with more than 1 seizure or possible seizure every 5 days undergo 5-day continuous electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.

Eligibility Criteria:
* Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria
* Age-matched girls without neurologic or cardiac problems entered as controls
Toe Walker Gait Trial

The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.

For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.


Eligibility Criteria:
Inclusion Criteria:

* Toe Walking secondary to CP
* Idiopathic TW
* Inability to ambulate with initial heel-contact
* Inability to bear weight and stand flat-footed for over one minute
* Inability to stand or hop on one foot (symptomatic) for more than one minute

Exclusion Criteria:

* Acid Maltase Deficiency Myopathy
* Acute Paralytic Poliomyelitis
* Spinal Muscular Atrophy-all types
* Stroke, ischemic or hemorrhagic, all types
* Multiple Sclerosis
* Traumatic Brain Injury (including Shaken Baby Syndrome)
* Unilateral ROM deficits in Knee or Hip
* Previous Achilles Tendon lengthening surgery
* Hemiplegic Cerebral Palsy
* Muscular Dystrophy-all types
Military Suicide Research Consortium

The Consortium's overall mission can be summarized as follows; each function is developed with the goal of clear military relevance:

1. Produce new scientific knowledge about suicidal behavior in the military that improves mental health outcomes for the investigators men and women in uniform.
2. Use high quality research methods and analyses to address problems in policy and practice that have a direct impact on suicide-related and other mental health outcomes for military personnel.
3. Disseminate Consortium knowledge, information, and findings through a variety of methods appropriate for decision makers, practitioners, and others who are accountable for ensuring the mental health of military personnel. This includes the rapid response function so that queries from decision makers and others to the Consortium are answered with speed and efficiency. Technical assistance and support for decision makers and others is an integral aspect of this Consortium function. This aspect of the Consortium will warehouse knowledge about suicidal behavior in general (e.g., from civilian and international sources as well as from military sources), so that military issues can be informed in a comprehensive manner.
4. Train future leaders in military suicide research through experience within a multi-disciplinary setting for Ph.D. students and postdoctoral scholars interested in research questions on military suicide of both a basic and applied nature.

This is a research consortium responsible for the conduct of a wide range of studies, including clinical trials. All clinical trials funded through the consortium will be registered separately.

Eligibility Criteria:
Inclusion Criteria:

* MSRC studies are inclusive of all individuals who are eligible as defined by each study's protocol regardless of age, gender, race or ethnicity, socioeconomic status, sexual orientation, and any other demographic characteristics. Measures and treatments are translated and culturally adapted to the extent possible.

Exclusion Criteria:

* Specific to each investigator's protocol.
Genetic Studies of Early-onset Dementia

The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.

The study population includes individuals affected by Alzheimer's Disease, mild cognitive impairment, other dementias, cognitively healthy individuals without memory problems, or their family members.

Ascertainment is across both males and females, and all race and ethnic groups.

Eligibility Criteria:
Inclusion criteria:

* 18 years and older
* Individuals diagnosed with dementia, their family members and unrelated healthy controls without dementia.

Exclusion Criteria:

-Individuals with competing diagnosis such as Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc., unless family members of a dementia affected individual