cyrilzakka/clinical-trials huggingface dataset:
Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.


Eligibility Criteria:
Inclusion/ Exclusion criteria

- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

Other protocol-defined inclusion/exclusion criteria may apply.
Role of US in Evaluation of Tendon and Ligament Abnormalities in Hand and Fingers

Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers in traumatic \& non-traumatic causes.

The hand and fingers are the most important functional parts of the body in daily life activities and are prone to traumatic injuries and susceptible to a wide array of inflammatory diseases. Tendon abnormalities of the hand and the fingers are common disorders, particularly among athletes and in the elderly. These abnormalities may be symptomatic degenerative changes, inflammatory, or rupture. Tendon disorders are a common cause of pain and loss of function. Chronic tendon disorders are much more common than acute injuries and are the result of overuse or age-related tendon degeneration.

There is a wide spectrum of hand and finger pathological conditions that can be demonstrated using Ultrasonography. Superficial structures of the wrist, hand, and fingers, including the tendons, ligaments, nerves, and vessels, are amenable to imaging with high-frequency US. US can depict masses and fluid collections, help locate radiolucent foreign bodies, characterize traumatic or overuse tendon or ligament pathology, and help evaluate compressive peripheral neuropathy and microvascular blood flow. Additionally, this modality improves the accuracy of therapeutic intra-articular or peritendinous injections and facilitates aspiration of fluid collections, such as ganglia.

Due to the improvement of imaging techniques in the last years, the performance of ultrasonography (US) in detecting pathological changes in the musculoskeletal system dramatically increased. Moreover, dynamic examination allows better evaluation of the type and extension of the lesions. An anatomical course of the nerves and tendons can be depicted by US, thus offering valuable information on the exact location and type of possible lesions.

The role of USG in the assessment of tendon disorders is steadily increasing due to its being low cost, fast, wide-spread availability, and non-invasive. Additionally, it may offer a dynamic assessment of the flexor and extensor tendons, collateral ligaments, and supporting structures of the fingers, such as the extensor hood and the volar plate, as well as space-occupying lesions.

The quality of USG assessment of anatomical structures in the hand has highly improved over the last time. The development of high resolution with the highest possible frequency of modern ultrasound equipment and the superficial location of most tendons allows the spectrum of tendon abnormalities to be easily depicted with USG. US facilitates dynamic, real-time evaluation of bones, joints, tendons, nerves, and vessels, making it an ideal imaging modality for hand and finger conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of pain or masses of the hands and the fingers or referred for assessment of tendon \& ligaments which are involved in such pain and swellings.

Exclusion Criteria:

* Patients with a recent history of local operative intervention will be excluded
Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles

Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles

The aims of the project are to develop a technology for obtaining mesenchymal stem cells extracellular vesicles; to develop biomedical cell product based on mesenchymal stem cells enriched with own extracellular vesicles; to conduct the clinical trials of the biomedical cell product in the treatment of patients with segmental bone tissue defects

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years;
* non-union fractures of the tubular bones of the upper limb;
* segmental defects of the bone tissue of the tubular bones of the upper limbs;
* absence of severe comorbidity worsening the patient's prognosis.

Exclusion Criteria:

* pregnancy;
* acute inflammatory processes;
* viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections;
* autoimmune diseases;
* allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
* mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction;
* patients with malignant tumors including a history.
Hyperopia Detection GCK With Glow Fixation

"GoCheck Kids" has added to its iPhone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. In pediatric eye patients, the "GCK" with glow box is compared to cycloplegic refraction as well as School Bus Accommodation-relaxing skiascopy, "2WIN" photoscreener and "Retinomax."

Patients undergoing comprehensive pediatric eye exam were screened with "GoCheck Kids" iPhone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as "Adaptica 2WIN" photoscreener and "Retinomax" auto refraction all without drops before cycloplegia examination.

Reason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted.

Refractive amblyopia risk factors utilizing "AAPOS 2003" and "AAPOS 2013" uniform guidelines were used to validate each screening method.

Patients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.

Eligibility Criteria:
Inclusion Criteria:

* Patients having comprehensive pediatric eye examination

Exclusion Criteria:

* Patients with only one eye
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic

A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.

An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder.

The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection.

Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation.

Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly.

Patients were treated up to 120 days.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than 18 years of age
2. Demonstrate capacity to consent to the study
3. A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.)
4. Experiencing acute stress disorder as determined by clinically validated screening tools -

Exclusion Criteria:

1. Currently on prescription medications for psychiatric issues
2. Currently pregnant or breastfeeding or actively trying to get pregnant
3. History of seizure disorder, liver disease, or psychosis/mania
4. Uncontrolled Hypertension
5. Physician discretion: any condition deemed inappropriate that will increase the risk -
Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for Rhegmatogenous Retinal Detachment

Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications.

Methods This is a prospective randomized controlled trial that included 58 eyes with RRD, divided into Group A (PFCL, n = 29) and Group B (PR, n = 29). Preoperative assessments included best-corrected visual acuity (BCVA), IOP, axial length, lens status, macula status, and PVR grade. Outcomes were evaluated at 1 week, 1 month, 2 months, and 3 months postoperatively. Primary outcomes included retinal reattachment rates and the number of operations; secondary outcomes included BCVA, IOP changes, complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success.


Eligibility Criteria:
Inclusion criteria:

A clear diagnosis of primary RRD requiring surgery, 18 years or older, The potential to return for follow-up visits for at least 6 months post-surgery.

Exclusion criteria:

When presented with tractional or exudative retinal detachment, had surgery on the affected eye in the past, presented with severe eye disorders like advanced glaucoma or endophthalmitis.
Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.

The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 17 years of age or older
* Stable cancer-related pain.
* Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain for at least 14 days prior to screening.
* Experiencing 1-4 episodes of breakthrough pain per day.
* Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.

Exclusion Criteria:

* Are pregnant or lactating.
* Have uncontrolled or rapidly escalating pain.
* Have moderate to severe ulcerative mucositis.
* Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
* Have neurologic or psychologic disease that would compromise data collection
* Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
* Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
* Have received strontium 89 therapy within 60 days prior to entering the study.
* Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
* Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
* Have hypersensitivities, allergies, or contraindications to fentanyl.
* Have a significant prior history of substance abuse or alcohol abuse.
* May have difficulty complying with the protocol, as assessed by the investigator.
Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction

By doing this study, the investigators hope to learn whether patients with difficult to obtain IV access who are treated with IO access are more satisfied with their care and have better outcomes. The investigators are specifically studying the time difference between groups and the difference in the number of attempts required to obtain vascular access and begin to treat with fluids and medications. The study will also measure patient satisfaction and procedural pain, the frequency of central line placement, the length of stay in the hospital and emergency department, and adverse events to intravascular access to determine whether IO access can improve these measures.

The investigators hypothesize that the use of a protocol utilizing an IO device for select patients with failed IV access will reduce the time requirements to obtain vascular access, reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no negative impact on patient satisfaction compared to the current ED practices.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Hemodynamically stable
3. Speaks English
4. Able to consent
5. Has difficult IV access

Exclusion Criteria:

1. Patients who are younger than 18 years of age, b) lack English fluency c) are unable to give informed consent d) require immediate central venous access e) have a history of osteomyelitis in the only target location of IO access f) have a fracture in the bone of the only target IO site g) have received an IO in the last 24 hours of the only target site h) are allergic to lidocaine i) pregnant or j) require a contrast CT scan as part of their ED care will be excluded.

While pregnant patients may benefit from rescue access the use of lidocaine to anesthetize the medullary space has not been studied in this population.
Clinical, Neurophysiological and Radiological Evaluation of Patients With Basal Ganglia Lesions

Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The aim of this study is to precisely evaluate patients with basal ganglia focal lesions both with or without loss of psychic-self activation.


Eligibility Criteria:
Inclusion Criteria:

* Basal ganglia lesions

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Dementia
Sensorimotor Training Exercise After Lower Extremity Burns

Burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. Impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. Balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. Therefore, to guide recovery accurately and facilitate rehabilitation after LLBI, multi-factorial assessment is required.

Burns to the lower limbs can cause pain, scar tissue contracture, impaired sensation, muscle weakness and postural imbalance are all potential complications of lower limb burn injury (LLBI) which negatively influence a person's ability to function normally

Sensorimotor training is a special form of proprioceptive and balance exercise that was designed for management of patients with chronic musculoskeletal pain syndromes. It is based on the concept that instead of emphasizing the isolated strength of a group of muscles around a joint, we should realize the importance of the central nervous system in regulating movement in order to reach proper firing patterns for maintaining joint stability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of thermal burn injuries at the lower extremities.
* Total body surface area burned approximately from 40 to 50%.
* Patients age: 20 to 50 years.

Exclusion Criteria:

* Cognitive or mentality dysfunctions.
* Psychiatric conditions.
* Fractures.
* Pregnancy.
* Cancer.
* Severe vascular complications.
Prospective Registry Of Therapeutic EndoscopiC ulTrasound

This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.

This is an observational, prospective, single centre study. This registry aims to evaluate long-term clinical success of EUS-guided therapeutic interventions (T-EUS), as well as adverse events, and clinical and technical variables asociated with clinical success and adverse events.

For the purpose of this registry, the following procedures will be considered to be T-EUS procedures:

* EUS-guided collection drainage
* EUS-guided biliary drainage
* EUS-guided gallbladder drainage
* EUS-guided gastro-enterostomy
* EUS-directed ERCP
* EUS-guided pancreatic duct drainage

Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.

All patients eligible for the abovementioned clinical indications, but finally undergoing alternative procedures (e.g. surgical interventions, percutaneous interventions or other endoscopic procedures) will be proposed to be enrolled in the registry as "controls". The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.

Eligibility Criteria:
Inclusion Criteria:

* subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
* 18 years old or older
* able to provide an informed consent to inclusion.

Exclusion Criteria:

* age \< 18 years
* inability or unwillingness to sign the informed consent form (ICF)
* contra-indication for endoscopy or use of fluoroscopy
A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence

The purpose of this study is to determine if buspirone combined with motivational enhancement therapy is effective in reducing marijuana use in marijuana-dependent adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women, 18 years of age to 65 years of age.
2. Meet DSM-IV criteria for marijuana dependence.
3. All subjects will agree to and sign a written, IRB-approved informed consent.
4. Subjects must live within a 60-mile radius of Charleston, SC, in order to improve study visit compliance.
5. Subjects must be willing to identify collateral individuals for contact purposes to facilitate follow-up appointments.

Exclusion Criteria:

1. Individuals meeting DSM-IV dependence for a substance other than marijuana with the exception of nicotine and caffeine. Dependence on nicotine and caffeine will be allowed since dependence on these substances commonly co-occurs with marijuana dependence and excluding these individuals would compromise study recruitment.
2. Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care.
3. Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications.
4. Individuals who present significant suicidal risk.
5. Individuals with significant cognitive impairment, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments.
6. Individuals currently receiving benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of buspirone treatment.
7. Pregnant or nursing women, or women who refuse to use adequate birth control, as buspirone has not been approved for use in pregnancy.
8. Individuals without stable housing, as contacting these individuals would be difficult.
9. Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis).
10. Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments.
Study for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease

Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of PND screening, early detection, and further, provide a basis for disease prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's patients undergoing elective deep brain stimulation
* Age ≥55 years
* ASA physical statusⅠ-Ⅲ
* Elementary school or above

Exclusion Criteria:

* patients with ASA physical status\>III
* patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors
* patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout
* patients who refused to join the study and lost to follow-up
Gut Microbiome & Gastrointestinal Toxicities as Determinants of Response to Neoadjuvant Chemo for Advanced Breast Cancer

The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective.

Many chemotherapeutic agents compromise the integrity of the mucosal barrier in the gut, allowing translocation of gram-positive bacteria in secondary lymphoid organs. While this has, until recently, been considered an undesirable side-effect, it may also represent one mechanism by which chemotherapy stimulates an effective anti-cancer immune response. The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective. The hypothesis is that gut microbial composition can influence immune response to the tumor, resulting in inter-individual differences in the response to anti-cancer therapies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with invasive breast cancer and prescribed a regimen that includes neo-adjuvant therapy prior to breast surgery.
* Able to provide informed consent.

Exclusion Criteria:

* History of previous malignancy, other than non-melanoma skin cancers
* Inability to tolerate phlebotomy
* Immunosuppressive therapy for any other condition
* Fever or active uncontrolled infection in the last 4 weeks
* Inflammatory bowel disease
* Surgery of the stomach, small or large intestines, appendectomy, gastric bypass or gastric banding in the past 6 months.
* Active autoimmune disease, including, but not limited to, Systemic lupus erythematosus (SLE), Multiple sclerosis (MS), ankylosing spondylitis