cyrilzakka/clinical-trials huggingface dataset:
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

Exclusion Criteria:

Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Clinical Intelligent Management System - Multilingual Exploration

This study aims to explore the diagnostic and therapeutic performance of a multimodal foundation model-based clinical intelligent management system in simulated outpatient scenarios. Specifically, it will compare the system's AI agent with general practitioners from different linguistic and cultural backgrounds worldwide, as well as various dialect and minority language regions in China.

The study will be conducted across multiple centers in diverse regions to comprehensively evaluate the system's adaptability. Using a prospective, single-blind design, each center will recruit primary care physicians.

Standardized simulated patients across all centers will be trained based on the same set of standardized cases and then will consult with four real physicians and the AI agent, ensuring consistency.

By comparing diagnostic and treatment quality, patient satisfaction, and clinical outcomes, this study aims to explore the system's effectiveness in enhancing primary care and patient management across different regions and linguistic environments.


Eligibility Criteria:
Inclusion criteria for primary care physicians:

* Fluent in the local languages spoken at each center.
* With the general practice medical qualifications.
* Agree to participate in the study and sign the informed consent form.

Inclusion criteria for simulated patient volunteers:

* Age ≥ 18 years.
* Fluent in the local languages spoken at each center.
* Able to use electronic devices with intelligent systems.
* Able to accurately express symptoms and participate throughout the process.
* Agree to participate in the study and sign the informed consent form.

Exclision criteria: N/A
Diabetes Distress, Psychological Well-being and Family Hardiness in Parents of Children and Adolescents With T1D

Parents have an important role in child's diabetes management. Many studies show that parental psychological stress and family dynamics are associated with parental diabetes-related distress and treatment outcomes among children and adolescents with type 1 diabetes.

The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life, positive and negative affect and adult attachment relationship pattern), family hardiness and characteristics of children with type 1 diabetes in a sample of mothers and fathers of children and adolescents with type 1 diabetes of ages up to 18 years.

In this study it is hypothesized that:

1. greater parental fear of hypoglycemia and diabetes-related burden are associated with lower family hardiness and worse psychological well-being parents and higher HbA1c levels in children and adolescents with type 1 diabetes;
2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower psychological well-being comparing to fathers.
3. parents of children and adolescents with type 1diabetes will report greater anxiety, lower psychological well-being and family hardiness comparing to parents of children without diabetes.

Standardized and validated questionnaires will be used to determine: parental fear of hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being, adult attachment relationship pattern and family hardiness.

The investigators will also measure parent daily involvement in child's diabetes management, frequency of blood glucose monitoring and parent general satisfaction with glycemic control. Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode will also be obtained. These measures will be correlated with other research variables.


Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers of children and adolescents with T1D of ages up to 18 years
* Minimal 1 year duration of Type 1 diabetes

Exclusion Criteria:

* Parents or caregivers of children and adolescents with T1D of ages over 18 years
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma

The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.

We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.

Eligibility Criteria:
Inclusion Criteria:

* Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

* Non-atopic patients
Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture

This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods.

Dupuytren's contracture is a disease mainly characterized by the progressive fibrosis of the palmar fascia with subsequent hand deformity and dysfunction. The current study seeks to explore, through this minimally invasive technique, ultrasound-guided needle knife dissection regarding ROM and patient satisfaction. The procedure will be carried out under ultrasound guidance to ensure safety and completeness with the accuracy of precise dissection. Primary outcome measures will concern hand mobility, and secondary measures will evaluate patient self-reported satisfaction and any complications for the 6-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with Dupuytren's Contracture.
* Willing to undergo ultrasound-guided needle knife dissection

Exclusion Criteria:

* Patients who have undergone previous surgery or needle apponeurotomy for Dupuytren's Contracture on the same hand.
* Active hand infections, open wounds, or dermatological conditions in the treatment area.
* Coagulopathy or use of anticoagulant that cannot be safely paused
* Neuromuscular disorders affecting hand function
* Pregnancy or breastfeeding
* Uncontrolled systemic illnesses, such as poorly managed diabetes or cardiovascular disease.
* Known hypersensitivity to local anesthetics.
Influence of Selenium on Prostate Cancer Related Biomarkers

Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of two different forms of selenium (selenium yeast and selenomethionine) on blood selenium levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of getting prostate cancer in their lifetime. Participants will be asked to take over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of twelve months.

We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched yeast (SY) (200 µg/day and 285 µg/day) for 9 months; the 285 µg/day SY is selected to deliver an equivalent selenium as in 200 µg/day SM to healthy men. The variability of SM in SY that will be used here is less than 3% and it accounts for 70.5% of the SM content in SY. As primary endpoints, we will determine the effects of these two forms of selenium on plasma levels of selenium and its metabolites as well as biomarkers of oxidative stress at several time points. As a secondary endpoint, the effect of these two forms of selenium on plasma PSA levels will be examined.

Eligibility Criteria:
Inclusion Criteria:

* No history or evidence of diabetes
* Male between the ages of 20-79
* PSA levels ≤ 4.0 ng/mL
* Not taking \>50 µg/day selenium as a dietary supplement including multi- vitamins
* Non-smoker
* No concurrently participating or have participated in any other clinical trial within at least 30 days of registration
* Health male

Exclusion Criteria:

* Evidence of prostate cancer
* Evidence of liver or kidney disease
Hats on Head Start: A A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs

The proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures.

The primary hypothesis is that children in Head Start programs, daycare programs, elementary schools, or summer camps are exposed to significant UV radiation throughout the day, and are not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary hypothesis is that these programs value sun safety as an important health behavior, but probably do not have the funding avilable to make it a priority.

The study aims are:

1. To assess current exposure to sun and UV in programs of children participating in an early childhood educational program.
2. To assess current policies regarding sun protection and sunscreen use in programs for early childhood education.
3. To assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education.
4. To explore association of sun protective behaviors with risk factors such as socioeconomic status, per student classroom budget, program setting (i.e. urban, suburban, or rural), race/ethnicity, size of school program, school budget for supplies, and ages of children enrolled in program.

The sample of stakeholders, who will be surveyed, is consistent with samples used in our prior research. A sample size of 250 phone interviews will be adequate to show trends in sun safety policies among early education programs. Power analysis is based on the use of sun protection, our primary outcome. Our preliminary data show that 15% of schools almost always or always schedule outdoor activities to avoid times when the sun was at peak intensity. The sample size required to sensitively detect a 20% difference in using sun protection between those that comply with recommendations and those that do not is 250 respondents assuming an alpha \< 0.05 and power \>= 0.8 in a two-tailed test on a two-group sample. This sample size will adequately power the study for detecting 30% difference in sun protection use between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Someone 18 years of age and older, who is a teacher, administrator, aide, or other staff member of a Head Start program, day care program, camp, or elementary school.
* Participants agree to a structured phone interview regarding their program's policies for sun safety, their opinions on certain health behaviors, and the demographics of their student population.
* Participants will be interviewed on the phone and guided through a questionnaire which should take approximately 10 minutes to complete.

Exclusion Criteria:

* Participants who do not know their program's procedures for sun protection will not be able to participate, but may transfer the phone call to another colleague who can answer the questions accurately. Participants without the ability to speak in English will be excluded from the study.
Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.


Eligibility Criteria:
Inclusion Criteria:

* Out-patients
* Able to perform neuropsychological tests
* Have a responsible informant
* DSM-IV-TR criteria for Dementia of the Alzheimer's Disease Type
* Mini mental State Examination (MMSE) = 15-24 both inclusive
* National Institute of Mental Health (NIMH) provisional criteria for depression in AD (NIMH-dAD)
* Cornell Scale for Depression in Dementia total score \> or = 8
* Patients who have never been treated with AD treatments or patients who have stopped AD treatment whatever the reason
* Patients either not currently treated with an antidepressant or patients being treated with an antidepressant at the recommended dose for at least 8 weeks without clinical efficacy, who can stop this treatment according to the investigator's opinion.

Exclusion Criteria:

* Patients not able to read or write
* Patients having participated in a study testing disease modifying therapy for AD, or in another study with administration of investigational drug or device within the previous 3 months prior to selection visit
* Depressive symptoms that, in investigator's judgment, are clearly due to a medical condition other than AD, or are a direct result of non-mood related dementia symptoms
* History of epilepsy or solitary seizure
* Medical history of Major Depressive Disorder more than 3 years before onset of the disease, treated with antidepressive drugs or electroconvulsive therapy
* Severe or unstable disease of any type that could interfere with safety and efficacy assessments
* Alcohol abuse or drug abuse or addiction, as judged by the clinician (excluding nicotine)
* Clinically relevant lactose intolerance
* Antidepressant treatment not stopped for at least 3 weeks before inclusion
* Significant worsening of depressive symptoms or high suicidal risk according to investigator's judgment
* For optional extension phase: medically instable Chronic Obstructive Pulmonary Disease and asthma, known hypersensitivity to donepezil hydrochloride or piperidine derivatives
CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)

This is an international, prospective, multicenter trial with the aim of characterizing circulating tumor DNA (ctDNA) for early response assessment in PCNSL patients treated with standard of care (SOC) 1st line therapy with a curative intent (Figure 1). Secondary endpoints are to assess the clinical characteristics, health-related quality of life (HRQoL), neurological status, and outcome of newly diagnosed primary central nervous system lymphoma (PCNSL) patients in the Nordic countries. Patients eligible for a curative intent SOC 1st line therapy, such as MATRix + high-dose chemotherapy and autologous stem cell transplantation (HDCT/ASCT), are eligible for the trial. Diagnostic tumor tissue, cerebrospinal fluid (CSF), and plasma samples are collected for ctDNA and translational analyses with the aim describing new prognostic and predictive biomarkers. Treatment responses are assessed with the International PCNSL Collaborative Group (IPCG) response criteria, and diagnostic and response assessment magnetic resonance imaging (MRI) images are centrally analyzed in order to describe new prognostic and predictive markers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years at diagnosis
* Histologically or cytologically verified diffuse large B-cell lymphoma (DLBCL) of the central nervous system (CNS)
* No prior treatment for PCNSL (pre-treatment corticosteroids are allowed and recommended)
* Fit for standard of care (SOC) 1st line therapy with a curative intent such as full-dose MATRix, according to local policy
* Able to give voluntary written informed consent
* If the patient is temporarily incapacitated to give the voluntary written informed consent, due to PCNSL, the informed consent can be obtained from a legally acceptable representative, according to the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Guideline for Good Clinical Practice (ICH-GCP) guidelines

Exclusion Criteria:

* Lymphoma outside the CNS
* History of prior hematological malignancy e.g. low grade B-cell lymphoma
* Psychiatric illness or condition, other than PCNSL, which could interfere with the ability to understand the requirements of the study
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer, Gleason Score \</=7
* An anterior visible lesion on mpMRI, that is accessible to IRE treatment
* Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)
* Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings
* Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines
* Serum PSA \</=15 ng/ml
* Life expectancy of \>/= 10 years
* Signed informed consent by patient
* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process

Exclusion Criteria:

* Men who have had previous radiation therapy
* Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* Men with a non-visible tumour on mpMRI
* Men with an inability to tolerate a transrectal ultrasound
* Men with latex allergies
* Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases)
* Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the prostate.
* Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
* Men not fit for major surgery as assessed by a Consultant Anaesthetist
* Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
* Presence of metal implants/stents in the urethra
* Men with renal impairment with a GFR of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
Whole Body Vibration Training for Diabetic Patients With Burn Injury

Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn

Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups

Eligibility Criteria:
Inclusion Criteria:

* chronic lower limb burns injury for more than 6 months
* Total body surface area (TBSA) burnt ≤ 30%.;

Exclusion Criteria:

* cognitive or mentality dysfunctions,
* psychiatric conditions,
* fractures,
* pregnancy,
* cancer,
* severe vascular complications,
* inability to walk
Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy

The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.

Myocardial viability plays an important role in improving the function of the heart. To date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability.

Olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. Research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. In addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. However, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified.

The purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* dilated cardiomyopathy

Exclusion Criteria:

* contraindication to angiotensin receptor blocker
* cardiogenic shock
* sensitive to rosuvastatin
* liver cirrhosis more than Child class B
Dipyridamole Induced Ischemia and Biomarkers

Analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy.

The prospectively enrolled patients were followed up to 5 years. Adverse major events (MI, stroke, death) suffered during follow-up were retrospectively analysed.

Eligibility Criteria:
Inclusion Criteria: 1. written informed consent. 2. clinical diagnosis of ischemic heart disease (IHD) -

Exclusion Criteria: 1. refused written informed consent. 2. lost data during follow-up

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