cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)

Hunter syndrome (Mucopolysaccharidosis II, \[MPS II\]) is a rare, genetically linked lysosomal storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S). Most MPS II patients will present with some degree of neurodevelopmental involvement, ranging from severe cognitive impairment and behavioral problems to mildly impaired cognition. This is an observational study; no investigational treatment will be administered. The primary objective of this study is to evaluate the neurodevelopmental status of pediatric patients with MPS II over time and to gain information to guide future treatment studies in this patient population.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria to be considered eligible for enrollment:

1. a. The patient has a deficiency in iduronate-2-sulfatase enzyme activity AND b. The patient has a documented mutation in the iduronate-2-sulfatase gene. OR c. The patient has a normal enzyme activity level of one other sulfatase
2. The patient is male, and is at least 2 years of age and less than 18 years of age at the time of informed consent.
3. The patient must have sufficient auditory capacity at enrollment, with or without hearing aids, in the Investigator's judgment to complete the required protocol testing, and be compliant with wearing the aids on scheduled study visits.
4. The patient, patient's parent(s), or legally authorized guardian(s) has voluntarily signed an Institutional Review Board / Independent Ethics Committee-approved informed consent and/or assent form(s), as applicable.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. The patient has clinically significant non-Hunter syndrome-related CNS involvement or medical or psychiatric comorbidity(ies) which, in the investigator's judgment, may interfere with the accurate administration and interpretation of protocol assessments, affect study data, or confound the integrity of study results.
2. The patient has a general conceptual ability score (GCA) or a developmental quotient on the cognitive scale below 55 at Screening.
3. The patient is participating in an interventional clinical trial or has participated in an interventional clinical trial within 30 days prior to enrollment; participation in non interventional observational studies is permitted.
ViVEXX Carotid Revascularization Trial (VIVA)

To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.

Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.

Eligibility Criteria:
Inclusion Criteria:

* The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:

  * Symptomatic: \> than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure.
  * Asymptomatic: \> than or = to 80% carotid stenosis by angiography without neurological symptoms.
* High risk for carotid endarterectomy: anatomical and co-morbid.

Exclusion Criteria:

* History of symptoms of stroke or TIA within 24 hours of the procedure
* Extensive or diffuse atherosclerotic disease
* Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
Development of Resistance Mutations in Pregnant HIV-positive (+) Women Following Perinatal Antiretroviral Therapy in Israel

It has been shown that treatment of HIV-positive women with antiretroviral medication during pregnancy reduces the risk of HIV transmission to the child. However, such treatment could lead to the selection of resistant virus strains in the mother. The object of this study is to check HIV+ pregnant women for resistance mutations in HIV before and after the antiretroviral therapy they receive during pregnancy. HIV-positive newborns will also be tested, to see if a resistant virus strain was transmitted from mother to child.

The project will be performed in collaboration with the Israeli National HIV Reference Center Laboratory, which maintains a national bank of HIV-positive blood samples, and with HIV/AIDS treatment centers located throughout Israel.

An initial survey will identify retrospectively those HIV+ women who were given antiretroviral therapy while pregnant and stopped treatment after delivery. The list of HIV+ deliveries over the past five years in each participating hospital will be reviewed, and all HIV-positive women who received antiretroviral treatment during pregnancy will be invited to participate in the study project. Women who are currently pregnant, or become pregnant during the study, will be invited to participate when pregnancy is diagnosed. After obtaining informed consent, two blood samples will be obtained: one before the initiation of perinatal treatment, and the other following delivery. (Due to technical limitations, only samples with viral loads above 1000 cp/ml can be genotyped. It is expected that HIV loads will rise following cessation of antiretroviral treatment, and that almost all samples will be eligible for resistance testing.)

In addition, after obtaining maternal informed consent, samples from newborns infected perinatally with HIV will also be tested for resistance mutations, and these will be compared with the resistance pattern found in the mother.

The samples obtained will be tested for genotypic resistance mutations. The results will be transmitted to the treating physician to assist in choice of antiretroviral therapy for the women and their children, if needed. The data will also be used to establish a national database to evaluate and improve existing protocols for perinatal antiretroviral treatment, and will be used to contribute to international databases of HIV resistance. All resistance data, except that given to the health care provider(s), will be transmitted without additional identifying information.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-positive women currently pregnant or with a past pregnancy in Israel
2. Blood/plasma samples available before and/or after perinatal antiretroviral treatment (before or during pregnancy if not treated)
3. HIV viral load in the samples adequate for resistance testing (approximately 1000 copies/ml)
4. Informed consent obtained

Exclusion Criteria:

1. Samples not available or inadequate viral load
2. Informed consent not obtained
The Effect of Light Therapy on Post-Surgical Pain

Researchers aim to demonstrate that the use of phototherapy is feasible and may reduce acute postoperative pain based on recent literature. The primary objective is to demonstrate that displaying light-emitting diodes \[LED\] can be achieved in the ICU setting in after cardiac surgery.

The primary aim of this study to determine whether or not green light phototherapy is feasible after cardiac surgery.

Patients that will be undergoing heart surgery will be recruited to the study. After surgery they will be exposed to either green or white LEDs for up to 5 hours per day and up to one week after surgery.

After their exposure to light therapy, a survey will be given to the patient which will ask questions regarding tolerance of the therapy. A survey will also be given to the staff which will query whether or not the therapy was an impediment to workflow. In addition, the medical record will be reviewed to assess opiate usage in each group as an exploratory aim which may suggest differences in pain experiences.

Eligibility Criteria:
Inclusion Criteria:

- Status post heart surgery and are admitted in the ICU at Mayo Clinic, Florida.

Exclusion Criteria:

* Patient with color blindness and/or untreated cataracts.
* Patients who are hemodynamically unstable.
* Patients with dementia/delirium.
* Pregnancy.
* Patient is unwilling to participate or provide informed consent.
* High baseline narcotic baseline requirements that would skew the baseline impact on post-op opiate pain requirements.
Understanding Health Care Information for African Americans With High Blood Pressure

This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). The research method relies on community participation in equal partnership with the researchers to provide interactive workshops and home blood pressure self-monitoring with the assistance of telephone counseling by community health workers.

The purpose of this study is to develop a culturally sensitive intervention focused on health literacy that is designed to reduce high blood pressure (HBP) in a vulnerable African American (AA) population. A community-based participatory research approach delivered by community health workers (CHW) will be used to address the following specific aims: Aim 1. To examine the effect of health literacy on self-care skills, including HBP knowledge, adherence to HBP and substance abuse treatment recommendations, communication skills, health care utilization, and BP outcomes in AAs with HBP. Aim 2. To conduct a pilot randomized, controlled trial with a delayed intervention control group to test the effectiveness of a health literacy-focused self-help HBP intervention program using CHWs in 100 AAs who reside in Baltimore City.

Eligibility Criteria:
Inclusion Criteria:

1. Self-identified as African American aged 18 years or older;
2. Systolic BP \>140 and/or Diastolic BP \>90 mmHg or SBP \>135 and/or DBP \>85 mmHg for individuals with diabetes mellitus or chronic kidney disease or on HBP medication; and
3. Has a land-based telephone in the home or a cellular phone.

Exclusion Criteria:

1. Participation in another ongoing trial;
2. Acute and/or terminal condition precluding participation, such as terminal cancer;
3. Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months;
4. Recipient of an organ transplant or on kidney dialysis; and
5. Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score \< 24)
Pupillometry in Horner's Syndrome

Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of the etiologies for ischemic stroke in young patients.

In our current study, we will explore the diagnostic accuracy of automated binocular pupillometry in the diagnosis or HS, and its potential in identifying dissection of the carotid artery in patients of young age who suffer ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Adults 60 years of age or younger
* Acute stroke (less than 72 hours from admission)
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Ability to understand the study information and consent form

Exclusion Criteria:

* known history of HS
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Medications affecting pupillary response
* History of ocular surgery affecting the pupil
Internet-based Treatment of Generalized Anxiety Disorder

The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV criteria for generalized anxiety disorder
* Living in Sweden and being able to read Swedish
* Access to computer with internet connection

Exclusion Criteria:

* Currently receiving other psychological treatment
* Non-stable use of psychoactive medication
* Deemed suicidal
* Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Modulation of Tissue Sodium in Hemodialysis Patients

Salt (NaCl) intake is implicated in causing hypertension and cardiovascular disease, the commonest cause of death worldwide. The investigators recently established that Na+ is stored in tissues, bound to glycosaminoglycans (GAGs) in skin and muscle. The resulting local hypertonicity leads to immune cell-driven induction of local tissue electrolyte clearance via modulation of cutaneous lymph capillary density. To visualize these complex processes in man directly, the investigators established Na+ magnetic resonance imaging (23Na-MRI) and investigated Na+ stores in hemodialysis (HD) patients. Hemodialysis patients were sodium-"overloaded" and HD treatment lowered tissue Na+ stores in this study. The observed effects were highly variable and independent of Na+ or water removal from the body during a dialysis session. Tissue Na+ mobilization correlated with circulating vascular endothelial growth factor-C (VEGF-C). The investigators believe that excessive Na+ storage is a reversible condition and therefore susceptible for therapeutic interventions. The investigators hypothesize that lowering dialysate Na+ concentration may favorably affect accelerated tissue Na+ accumulation in hemodialysis patients. Besides, improved tissue Na+ storage, osmostress-induced as well as pro-inflammatory immune cell response should be affected by such a revised dialysis management.

To evaluate effects of moderate reduction of dialysate Na+ concentration on tissue Na+ content the investigators intend to recruit 40 hemodialysis patients, who will be offered a therapeutic change of their dialysate Na+ concentration. After detection of tissue Na+ content using 23Na-MRI technique, the applied dialysate \[Na+\] will be initially increased stepwise by 2 mmol/l per week from 138 to 142 mmol/l and maintained for a period of 5 weeks. After another 23Na-MRI measurement, dialysate \[Na+\] will then be lowered stepwise by 1-2 mmol/l per week to a minimum of 135 mmol/l, which will be also maintained for a period of 5 weeks followed by a final 23Na-MRI assessment.

Hypothesis: Reduction of dialysate Na+ concentration will decrease tissue sodium storage.

Additionally, the investigators will assess changes in body fluid distribution by bioimpedance spectroscopy. Furthermore, vascular compliance in response to the modulation of dialysate \[Na+\] and its correlation with tissue Na+ will be assessed. To investigate the immune response to tissue Na+ accumulation, the osmostress-induced as well as pro-inflammatory immune cell response of isolated monocytes will be quantified.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Stage 5D, hemodialysis performed for at least 6 months, three times hemodialysis per week, signed informed consent

Exclusion Criteria:

* Pregnancy, severe heart failure (NYHA III - IV), severe liver disease (CHILD C), acute infection, pacemaker or other non-MRI suitable conditions, hyponatremia \< 132 mmol/l
Survival of Implant-Supported All-Ceramic Prostheses

The purpose of this research study is to identify reasons that cause an all-ceramic bridge to fracture which include the thickness of the bridge material, the type of bridge material and the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic bridge. The investigators are conducting this study so we can make bridges which can withstand forces in the mouth which tend to break them.

The overall objective of this research is to analyze how properties of ceramic materials and different forces in the mouth interact with each other to affect the longevity of these bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting substrate, core thickness, connector height, wear, loading orientation, and maximum clenching force.

The long-range goal of the proposed research is to formulate design survival statistics that will aid the dental community in fabricating properly designed prostheses that can predictably survive the oral environment.

Patients who qualify for this study will be randomized (as in chanced with the flip of a coin) into two groups. The first group is a metal-ceramic group where patients will receive a bridge with a metal substructure underneath. The second group is an all-ceramic group where patients will receive a bridge which is made of hard ceramic material. All patients will receive two dental implants which will bond to bone for a period of 4-6 months. An impression or mold of the implants will then be made and a bridge will be fabricated based on the randomization of the patient. Patients will be asked to return at 6 months and yearly thereafter up to 5 years. During these recall appointments, photographs will be taken and impressions of the bridge and other teeth will be made. This will allow us to measure the amount of wear happening with the bridge and the other teeth. The investigators can also examine the amount of bone around the implants as well as the integrity of the bridge.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 21-75 years, and no contraindications to dental treatment.
* Good overall dental health, no active caries, no periodontal disease, and periodontal pocket depths not greater than 4 mm.
* Missing at least three teeth in the posterior area of the mouth.
* Natural teeth opposing the edentulous area and a full complement of teeth or restored teeth in all other areas of the mouth
* Adequate bone height and width at areas of proposed implant sites
* Adequate interocclusal distance to accommodate prosthesis
* Good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces.
* Compliance with appointments and willing to pay $2625 for a 3-unit implant supported FDP

Exclusion Criteria:

Non compliance Not enough teeth remaining Uncontrolled medical condition
VNOTES and Vaginal Hysterectomy for Benign Indications

This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.

A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* aged between 40 and 80 years
* undergo hysterectomy for benign gynecological conditions

Exclusion Criteria:

* history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
* suspected gynecologic malignancies,
* endometriosis,
* tubal-ovarian abscesses,
* pelvic organ prolapse exceeding grade 2,
* individuals who refused to participate in the study
Hybrid L24 New Enrollment Post Approval Study

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.


Eligibility Criteria:
Inclusion Criteria:

Ear to Be Implanted:

* Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted
* CNC word recognition of 10-60% in the ear to be implanted

Contralateral Ear:

* Moderately severe to profound mid to high frequency hearing loss in the contralateral ear
* CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct

Exclusion Criteria:

* not proficient in English
* unwilling and/or unable to comply with the test protocol
* deafness due to lesions of the acoustic nerve or central auditory pathway.
* active middle-ear disease, with or without tympanic membrane perforation.
* absence of cochlear development.
* duration of severe to profound hearing loss of 30 years or greater
"Bilateral Training in Stroke Patients"

The objective of this study was to evaluate the effects of bilateral training for upper extremity in stroke patients and to compare these effects between right and left stroke patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24 stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B (Left hemiplegia) (n=12). Chronic stroke patients (\>3 months), aged 30-70 years with left or right sided diagnosed stroke patients were included while patients on medication that could affect the cognitive functions or with any other cognitive impairments who are not able to follow commands were excluded. Both groups received the same intervention of with bilateral arm training involving 5 functional tasks to improve the functional activities of daily living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.


Eligibility Criteria:
Inclusion Criteria:

* left or right-sided chronic stroke patients

Exclusion Criteria:

* Patients with cognitive impairment or unable to follow commands
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy

This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status (ASA) ≤ III
* Age 18-80 year
* Height between 160 and 185 cm
* Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

* Cardiac pathology (such as Heart failure, Aortic stenosis)
* Coagulation disorders (INR\>1.3, platelet \< 80 000/mm3)
* Known allergy to local anaesthetics
* Disagreement of the patient
Optimization of Ureterolysis During Hysterectomy

The purpose of this study is to improve the safety of surgery to remove a uterus (a hysterectomy) by better understanding where a patient's ureters lie.

Objectives:

Primary: (While uterus is under tension)

* To determine the shortest distance from the ureter to the uterine vessels.
* To determine the distances from the ureter to the gonadal vessels in infundibulo-pelvic (IP) at the pelvic sidewall. This will be defined at the distance from the IP ligament at the level of the pelvic sidewall to the point on the ureter directly below these vessels
* To determine the distances from the ureter to the gonadal vessels in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This will be defined as the distance from where the vessels in the IP enter the ovary to the point on the ureter directly below this.

Secondary

* To determine thermal spread from the Ligasure, and Harmonic device using H\&E and Movat staining.
* To determine the burst pressure of segments of IP ligament that have undergone Ligasure or Harmonic electrosurgery.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing minimally invasive surgery (MIS) hysterectomy with Bilateral Salpingo Oophorectomy (BSO) for either a benign or malignant condition.
* Performance Status of 0-1
* Must have the ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* History of radical pelvic surgery.
* History of stage IV-V uterine prolapse or hysteropexy
* History of prior ureteral injury or retroperitoneal dissection
* Known hydronephrosis.
* Known congenital genitourinary or gynaecologic anomaly
* Any known obstructing mass along any portion of the pelvic ureter
* Known American Society for Reproductive Medicine (ASRM) stage III/IV endometriosis (obliteration of the cul-de-sac)