cyrilzakka/clinical-trials huggingface dataset:
JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response, and Survival Outcomes

Bladder cancer(BC) is the 10th most common cancer globally, with a higher incidence in males than females, being the 6th most common cancer in men with high mortality, causing a societal burden worldwide.

Known risk factors include age, gender, cigarettes, genetic factors, and other environmental influences .

BC can be classified into non-muscle-invasive BC (NMIBC) and muscle-invasive BC (MIBC) . MIBC exhibits a more aggressive nature, correlates with a higher level of T-stage, and has more significant genetic heterogeneity .

Despite comprehensive treatment regimens comprising neoadjuvant chemotherapy, radical cystectomy (RC) and adjuvant immunotherapies, a significant proportion of MIBC patients continue to progress to more advanced stages with limited clinical indicators.

Unfortunately, the mechanisms underlying BC initiation, proliferation, and progression remain largely unknown.

The occurrence of genetic alterations is believed to be closely linked to BC tumorigenesis. Therefore, investigating the genetic alterations might offer opportunities to further understand biological changes in BC .

A key mechanism underlying tumor progression and metastasis is the epithelial-mesenchymal transition (EMT), which is associated with increased invasiveness, chemoresistance, and immune evasion.

EMT is characterized by the downregulation of epithelial markers such as E-cadherin (CDH1) and the upregulation of mesenchymal markers like N-cadherin (CDH2), vimentin, Snail, and ZEB proteins .

Emerging evidence suggests that junctional adhesion molecule 3 (JAM3) plays a role in EMT and cancer progression, with documented involvement in gastric cancer.

However, its significance in MIBC remains poorly understood. Investigating JAM3 expression in MIBC may provide novel prognostic insights and help refine patient stratification for NAC and immunotherapy.

Aim:

This study aims to analyze JAM3 expression in transurethral biopsies from MIUC patients and correlate it with:

* Tumor aggressiveness (grading, staging, and histological features).
* Response to neoadjuvant chemotherapy .
* Patient survival and disease progression.

This study will provide a better understanding of JAM3's role in EMT and MIUC progression, offering potential biomarker-driven insights for treatment stratification.

If JAM3 is validated as a prognostic factor, it could guide personalized therapeutic approaches and optimizing NAC outcomes.


Eligibility Criteria:
Inclusion criteria

1. Patients above 18 years
2. Histopathological confirmed TCC
3. Patients with MIBC
4. Patients eligible for neoadjuvant chemotherapy

Exclusion criteria

1. Patients with metastatic disease
2. Patients ineligible for systemic therapy
Audit of Lung Cancer Screening Practice in Chest Physicians: An Update

The investigators will conduct nationally representative survey in chest physicians in Egypt in 2016-2017. Self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.

Although current practice guidelines do not recommend screening asymptomatic patients for lung cancer, physicians may still order lung cancer screening tests. No recent national survey of health care professionals has focused on lung cancer screening

Eligibility Criteria:
Inclusion Criteria:

* Physicians practising in Egypt (Chest physicians, general practitioners, and general internists)

Exclusion Criteria:

* Other nationalities
* Other specialities
Duloxetine Versus Placebo in the Treatment of FMS

To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* meet criteria from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination
* measure average pain item of the BPI at Visits 1 and 2

Exclusion Criteria:

* have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
* have regional pain syndrome, multiple surgeries or failed back syndrome
* have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
* have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia
Management of Neuromuscular Blocking Agents and Their Antagonism

Neuromuscular blocking agents (NMBA) are commonly used in clinical practice during general anesthesia to facilitate induction, intubation and surgery. Some studies have shown that their use can be deleterious if not codified. Recent recommendations concerning their use and antagonization were published in 2023.

Research hypothesis:

Using a single-center, retrospective practice study, we aim to analyze whether the 2023 ASA and ESAIC recommendations are being implemented regarding the use of neuromuscular blocking agents.


Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing surgery with use of neuromuscular blocking agents at our institution

Exclusion Criteria:

- Incomplete electronic anesthesia record
Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group


Eligibility Criteria:
Inclusion Criteria:

* Pediatric Patients with thalassemia major.
* Pediatric Patients with congenital heart disease undergoing surgical repair.

Exclusion Criteria:

* known hepatic or renal disease
* uncontrolled active hemolytic reaction
* emergency surgery
* redo surgery
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.

Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

This is an investigator-blinded, multi-center pilot randomized controlled trial (RCT) of adolescents with sickle cell disease (SCD) and caregivers of young children with SCD. After completion of a run-in period, subjects will undergo randomization to either six months of video directly observed therapy (VDOT) or attention control. Electronic adherence monitors will be used to measure adherence. After the intervention period, all participants will then complete a six-month ongoing monitoring period where VDOT participants will continue to use electronic adherence monitors and receive intermittent communication to encourage adherence and attention controls will continue to use their electronic adherence monitors.

The investigators are partnering with a small business, Scene Health, to administer VDOT. Outcomes such as engagement, retention, and satisfaction will be measured through survey data collected at routine study visits. Sickle cell-related outcomes and healthcare utilization will be abstracted from patient electronic medical records throughout each study period. Adherence data will be recorded by the electronic adherence devices.

Eligibility Criteria:
Inclusion:

Adult caregivers will be eligible if they:

* Are English speaking.
* Have a child who is 1-10 years of age with SCD (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment.
* Note: Caregivers who have multiple children meeting criteria will only be able to enroll once.

Adolescents (\>11 years at enrollment) are eligible if they:

* Are English speaking.
* Are 11-25 years of age.
* Have a diagnosis of SCD (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment.

Exclusion:

* Adolescents and caregivers of younger children who participated in the previous VDOT study will be excluded.
* Adolescents and caregivers of younger children receiving multiple SCD modifying treatments (e.g., chronic transfusions or L-glutamine) will be excluded.

Randomization: enrolled subjects will be eligible for randomization if they open their electronic adherence monitoring device at home at least once during the run-in period.
Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Able to give informed consent
* Referred for isolated aortic or mitral valve repair or replacement due to valve regurgitation

Exclusion Criteria:

* Inability to provide consent.
* Pregnancy
* Claustrophobia
* Metallic contraindications to MRI (e.g. noncompatible aneurysm clip etc)
* Known intracardiac shunt
* Planned concomitant cardiac surgical procedure such as coronary artery bypass, septal myomectomy, or other valve procedure.
* More than mild mitral or aortic stenosis.
* For patients enrolled with mitral regurgitation: greater than mild aortic regurgitation.
* For patients enrolled with aortic regurgitation: greater than mild mitral regurgitation.
* Hypertrophic cardiomyopathy.
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)

Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus for greater than 5 years (C-peptide negative)
* Age 18-55 years
* Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
* History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks

Exclusion Criteria:

* History of hypoglycemia induced seizures
* Pregnancy
* Significant baseline anemia (hemoglobin \< 11.0g/dl or hematocrit \< 33%)
* A history of liver cirrhosis or porto-caval shunt surgery
The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling

Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of those drugs used in previous clinical trials, therefore recommended in practical guidelines is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose is more efficacious compared to lower dose commonly used in clinical practice. In addition, the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has not been explored in the setting of post-MI remodeling.

Therefore, the investigators evaluate whether submaximal dose, which are lower than those in major pivotal trials but typically used in clinical practice, can offer similar benefit in post-MI ventricular remodeling.

A total of 1116 patients with left ventricular (LV) dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to maximal tolerable dose (up to 320 mg/day) or usual dose (80 mg/day) of valsartan for 12 months in 2:1 ratio. Echocardiographic analysis for quantifying post-MI ventricular remodeling and genotyping of blood samples are conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times, and genetic polymorphisms of the patients are tested at the time of admission.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Age \> 18
* First episode of acute ST-elevation MI
* An echocardiographic left ventricular ejection fraction less than 50 %
* Patients who provide written informed consent

Exclusion Criteria:

* Contraindications for use of angiotensin receptor blockers (ARBs)(hypersensitivity, pregnancy, bilateral renal artery stenosis)
* Urgent need for revascularization procedure
* Severe heart failure (need for intravenous inotropic support)
* Persistent (\> 1 hour) severe hypotension (systolic blood pressure \< 90 mmHg)
* Refractory or potentially lethal arrhythmias
* Hemodynamically significant right ventricular infarction
* Primary valvular diseases
* Congenital heart disease
* Idiopathic hypertrophic cardiomyopathy
* Concomitant inflammatory cardiopathy
* Significant hepatic dysfunction
* Significant renal dysfunction
* Anemia (hemoglobin \< 10 mg/mL)
* Psychiatric disorders, alcohol or durg abuse
* Any concomitant disease that might interfere with drug evaluation (especially if life expectancy is less than 1 year)
* Participation in any other pharmacological study within 2 months
* Refusal or inability to provide informed consent
Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe chronic plaque psoriasis
* Active psoriasis, despite topical therapies

Exclusion Criteria:

* Other active skin diseases or skin infections
* Prior exposure to any anti-TNF therapy
* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis
Light Therapy for Moderate Traumatic Brain Injury

The purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI).

The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the response to LLLT through MR imaging and clinical outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old;
* Injury within 72 hours at the time of consent;
* Head injury requiring hospital admission;
* A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.

Exclusion Criteria:

* Need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters);
* Hemodynamic instability as determined by the clinician;
* History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia, Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing, hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases, Wernicke-Korsakoff syndrome, and dementia of unknown etiology.
* Pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study);
* Electrical implants such as cardiac pacemakers or perfusion pumps;
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, or any other contra-indications to MRI.
* Clinical determination that subject cannot undergo MRI
* Breastfeeding
* Unstable cervical fractures
* Scalp lacerations or surgical wounds severe enough to preclude safe application of device
* Unreliable to follow up
Immunization Protection in Child Care (IPiCC) Project

Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.

Specific Aim 1 will describe Utah state and local government activities to ensure compliance of child care programs with state immunization requirements and identify government's barriers to ensuring compliance.

Specific Aim 2 will describe child care program staffs' knowledge, attitudes, and activities related to ensuring that all children are up-to-date for required immunizations and identify program barriers to ensuring up-to-date status.

Specific Aim 3 will evaluate at least 3 strategies to ensure that all children enrolled in child care programs are up-to-date for required immunizations. Aims 1 and 2 will guide the design of these strategies. Specific strategies proposed for Aim 3 are to: 1) design and pilot test an intervention to increase child care program use of the Utah State Immunization Information System (USIIS), 2) design an online immunization education module and conduct a pilot randomized controlled trial to determine whether use of the module changes child care providers' knowledge, attitudes, and activities and increases the proportion of children who are up-to-date for required immunizations; and 3) conduct a pilot randomized controlled trial to determine whether a quality improvement intervention implemented in child care programs increases the proportion of children who are up-to-date for required immunizations.

Eligibility Criteria:
Inclusion Criteria:

Child care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.

Exclusion Criteria:

Child care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non childbearing potential, age \> or = 50.
* Diagnosis of probable Alzheimer's disease, consistent with criteria from both:

  * National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
  * Diagnostic and Statistical Manual of Mental Disorders (DSM IV).
* Mini-mental status exam score of 16-26 inclusive.
* Rosen-Modified Hachinski Ischemia Score of \< or = 4.

Exclusion Criteria:

* Diagnosis or history of other demential or neurodegenerative disorders.
* Diagnosis or history of clinically significant cerebrovascular disease.
* Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.
* History of autoimmune disorders.
* History of allergic or anaphylactic reactions.
Evaluation of a Gatekeeper Training for Pharmacists

This study aims to investigate to what extent a gatekeeper training (e-learning) for pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy. Moreover, it aims to examine how they evaluate the training and whether they were able to apply the learned skills in practice.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Have access to internet
* Speak Dutch
* Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)

Exclusion Criteria:

* Hospital pharmacists or industrial pharmacists are not included in this study and thus constitute an exclusion criterion.