cyrilzakka/clinical-trials huggingface dataset:
Does Cryofixation of Skin Specimens Affect Quality of Subsequent Formalin Fixed Paraffin Embedded H and E Histology

This prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether:

1. The process of cryofixation prior to generating formalin fixed paraffin embedded (FFPE) H\&E sections alters the histology in skin tumor specimens.
2. Which specific histologic parameters are altered between previously cryofixed versus routine FFPE sections. Histologic observations will be recorded by two dermatopathologists and two Mohs surgeons and statistically analyzed.

Generating formalin fixed paraffin embedded (FFPE) hematoxylin and eosin (H\&E) stained permanent sections from previously cryofixed tissue is a common practice used to confirm diagnosis of frozen section histology. In dermatology, this practice can be used to examine Mohs layers and its debulk as well as routine nonmelanoma skin cancer (NMSC) biopsies after initial histologic diagnosis with frozen sections. Even though freezing tissue can introduce histologic artifacts, there have been no studies documenting whether this occurs specifically in cryofixed tissues that are subsequently thawed for permanent FFPE H\&E histology. The purpose of our study is to determine whether the freeze-thaw process used to generate permanent sections after cryofixation introduces significantly detectable histologic differences compared to permanent sections that were not previously cryofixed. Thirty debulk specimens of basal cell and squamous cell carcinomas will be prospectively collected. Each specimen will be split so that half is processed as cryofixed permanents and the other half as noncryofixed permanents. The investigator will show each slide in random order to a group of four blinded participants (two dermatopathologists and two Mohs surgeons). Each participant must first rate the overall quality of histology. Then, each participant will rate each slide on the quality of cellular morphology, nuclear morphology, color and contrast of stains, intactness of specimen, and other miscellaneous artifacts. These data will then be analyzed for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 or over) with a biopsy proven routine basal cell or squamous cell carcinoma of the skin who are scheduled for treatment with the Mohs procedure by Dr. Christopher Miller at the University of Pennsylvania's Division of Dermatologic Surgery will be included. Both female and male patients will be included.

Exclusion Criteria:

* Patients with basal cell or squamous cell carcinomas of more complex histopathology will be excluded from the study. Complex histopathology of a tumor is defined as features with aggressive, moderately to poorly differentiated, or unusual histopathology.
PULsecath mechanicaL Support Evaluation

The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

This is a mechanistic exploratory study. The objective is to determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. These specific patterns are so far unknown. Knowledge of optimal patterns may help in determining the ideal circulatory device platform.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 18 years;
2. Informed Consent must be signed by the patient, prior to HR-PCI;
3. The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
4. Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.

Exclusion Criteria:

1. No written informed consent;
2. Left ventricular thrombus;
3. Interventricular septal defect;
4. Significant peripheral arterial disease or arterial lumen size \< 6mm at the level of the common femoral artery;
5. Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
6. Cardiogenic shock;
7. Previous stroke within the last 3 months;
8. Major bleeding event within last 3 months;
9. Chronic kidney disease with a GFR \< 25 mL/min;
Stimulating After Recovery From Traumatic Brain Injury

This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older
* Diagnosis of a mild to moderate TBI (GCS \> 8 on admission)
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Healthy participants:

* Adults 18 years and older
* Able to perform a computerized assessment
* Willing to attend all scheduled appointments
* Able to undergo the informed consent process

Exclusion Criteria:

* Open wound on scalp
* Severe TBI diagnosis or GCS of less than 8 on admission
* Non-English speaking
* Incarcerated
* Implanted defibrillator or pacemaker
* Visual impairment that hinders ability to complete computerized assessments

Healthy subject exclusion criteria:

* Less than 18 years of age
* Open wound on scalp
* TBI diagnosis
* Non-English speaking
* Incarcerated
* Implanted defibrillator or pacemaker
* Visual impairment that hinders ability to complete computerized assessments
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.

A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
* Confirmed diagnosis between 1st July 2010 and 30th June 2011.
* Female patient managed for her disease at the same setting where final diagnosis of MBC was performed.

Exclusion Criteria:

* History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).
Randomized Assessment of TcMS for VT Storm

Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.


Eligibility Criteria:
Inclusion Criteria:

* ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug

Exclusion Criteria:

* Plan for catheter ablation of VT in the next 24 hours
* Pregnancy
* Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck \[except the mouth\], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)
The Effect of Molar Incisor Hypomineralisation on the Stomatognathic System

This study aims to examine whether children with Molar Incisor Hypomineralization (MIH) are more likely to have problems with the jaw joint and chewing muscles. MIH is a dental condition where the enamel of the first molars and incisors is weaker than normal. The researchers performed clinical examinations and ultrasound imaging to evaluate the thickness and elasticity of the chewing muscles. They also used a questionnaire to check for symptoms of temporomandibular disorders (TMD), such as jaw pain, headaches, and joint sounds.

This prospective clinical study investigates the potential impact of Molar Incisor Hypomineralization (MIH) on the stomatognathic system in children. MIH is a developmental enamel defect that affects the first permanent molars and incisors, resulting in weakened enamel and increased sensitivity. While MIH has been well documented in the context of dental health, its broader functional consequences remain underexplored. A total of 84 children aged 9-14 years participated in this study, including 43 with MIH and 41 healthy controls. The evaluation involved both clinical and ultrasonographic examinations. Temporomandibular disorders (TMD) were assessed using the Fonseca Anamnestic Index and through clinical parameters such as joint sounds, headaches, mandibular deviation/deflection, and mouth opening limitation. Ultrasound imaging, including shear wave elastography, was used to evaluate the thickness and elasticity of the masseter, temporalis, and sternocleidomastoid muscles, as well as the articular disc of the temporomandibular joint.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 9 and 14 years
* Good general health with no systemic disease
* Score of 3 or 4 on the Frankl Behavior Rating Scale
* No parafunctional oral habits (e.g., bruxism)
* No skeletal orthodontic abnormalities
* For the MIH group: presence of at least one first permanent molar diagnosed with MIH
* For the control group: absence of MIH diagnosis

Exclusion Criteria:

* Presence of advanced periodontal disease or tooth mobility
* History of facial trauma or jaw fracture
* Current medication use
* Inability to cooperate during clinical or ultrasonographic examinations
* Any condition that may affect temporomandibular joint structure or function
Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention

Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male subject aged 45 years or above, or female subject aged 55 years or above (age-related CVD risk factor)
* At least another of the following risk factor for CVD: cigarette smoking, hypertension, low HDL cholesterol or high LDL cholesterol, family history of premature coronary heart disease, elevated waist circumference
* Willingness to participate in the survey and complying with the study by signing a written informed consent

Exclusion Criteria:

* No or 1 risk factor for CVD; symptoms of PAD; diabetes mellitus; coronary heart disease or equivalents
* No lipid data collected in the last 12 months
* Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study; unwilling or unable to provide informed consent
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases

This is an open-label Phase 2 study evaluating the long term safety and tolerability of GFB-887 in patients with focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD)

Participants will be enrolled from the ongoing GFB-887 multiple ascending dose trial. Participants will be transitioned to a 200 mg QD dose level regardless of the dose received in the previous study although the data review team (DRT) and Medical Monitor may elect to decrease or increase the dose to minimize adverse events or improve clinical efficacy. The DRT may also elect to change dosing levels due to emerging data on GFB-887. Participants will take GFB-887 once daily at home. A phone visit will be conducted at Week 4 and at Week 8 to assess safety and tolerability. Participants will return to the clinic for follow up visits at Weeks 12, 24, 36, 48, and every 24 weeks thereafter through approximately 3 years from the time of the participant's first dose to evaluate long-term safety and durability of response (for up to approximately 13 scheduled in-clinic visits).

Eligibility Criteria:
Inclusion Criteria:

* Participants with FSGS/TR-MCD who have completed the treatment phase from an interventional clinical study with GFB-887. Participants who were discontinued for rising proteinuria from a GFB-887 interventional study may be considered for enrollment following consultation with the Medical Monitor.
* Participants who enrolled in any other interventional study during the time between completion of the prior GFB-887 interventional study and this study may be considered for enrollment following consultation with the Medical Monitor.

Exclusion Criteria:

* Participant is unable to take oral medications
* Participant has an unstable medical condition based on medical history, physical examination, laboratory tests, ECGs, vital signs or is otherwise unstable in the judgement of the Investigator which would pose a risk to the participant or interfere with study evaluation, procedures, or completion
* Evidence of significant hypersensitivity, intolerance, or allergy to any component of investigational product GFB-887
Understanding the Effects of Intervention on the Brain in Autism

This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.


Eligibility Criteria:
Inclusion Criteria:

* Verbal, speaking in full sentences
* Meets ASD criteria
* Meets IQ criteria \>70

Exclusion Criteria:

* schizophrenia or bipolar disorder
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.

This study will focus on PNS injuries that cause foot drop.

Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.

The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 88 years
2. Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
3. Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device\[s\] is permitted)

Exclusion Criteria:

1. Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
2. Current participation in orthopedic or rehabilitation medical programs
3. Active deep venous thrombosis
4. Distal paretic leg skin lesions, infections, or soft tissue inflammation
PET Imaging and Bariatric Surgery

The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60 years
* BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities
* Weight less than 350 pounds

Exclusion Criteria:

* History of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine
* History of psychiatric disorders
* Use of any antidepressants or psychotropics in the past 12 months
* Diabetes Mellitis
* Positive pregnancy test
* Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study
* Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI
* Inability to travel to Nashville, TN four times
A Study of Gaboxadol in Primary Insomnia

To evaluate the safety and tolerability of gaboxadol in primary insomnia.

To obtain long-term safety and tolerability data with gaboxadol.

Eligibility Criteria:
Inclusion Criteria:

* patients with Primary insomnia
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).

It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
* Anticipated \>=50% daily ventricular pacing
* LVEF \>=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
* Minimum age of 18 years, and at least 1 year life expectancy

Exclusion Criteria:

* Prior tricuspid valve replacement (annuloplasty is permitted)
* Intrinsic rhythm \< 30bpm
* Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
* Echocardiographic window of insufficient quality for measuring LVEF
* Life expectancy of \< 1year
* Pregnancy (women of childbearing potential will undergo pregnancy testing)
* Unable of unwilling to sign a patient informed consent form
Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
* Responsible for a motor deficit in the right or left lower limb.
* No neurological history other than stroke.

Exclusion Criteria:

* Multifocal stroke
* Patient having received a botulinum toxin injection to the lower limb to be vibrated
Understanding Dexmedetomidine in Neonates After Open Heart Surgery

The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be less than or equal to 1 month old.
* Postconceptual age must be \> or equal to 37 weeks on the day of surgery.
* Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
* Planned tracheal extubation within 24 hrs post-op.
* Adequate renal function (serum creatine \< or equal to 1.5mg/dL)
* Adequate liver function (ALT \< or equal to 165 U/L)
* Isolated heart surgery
* Informed consent

Exclusion Criteria:

* Patients who have received another investigational drug since birth.
* Patients receiving continuous infusions of muscle relaxants in the post-op setting.
* Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
* Patients who show signs and symptoms of elevated intracranial pressure.
* Post-op hypotension defined by post conceptual age.
* Pre-existing bradycardia defined by age
* Heart block
* Weight \< 2kg
* Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study