cyrilzakka/clinical-trials huggingface dataset:
Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint

Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.

The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media.

This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.

Eligibility Criteria:
Inclusion Criteria:

* age over 45 years
* primary knee joint OA Kellgrance-Lawrence grade 2 or 3,
* never had surgery or intra-articular injection before,

Exclusion Criteria:

* currently experiencing local infections and/or systemic infections,
* have a history of autoimmune disorders or immunodeficiency,
* have had surgery or injections on the knee joint,
Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes

This phase I trial tests whether embolization done prior to surgery (preoperative) will improve surgical outcomes in head and neck tumors with large amounts of blood vessels (hypervascular). Embolization is a minimally invasive surgical technique performed under angiographic (imaging of blood vessels) guidance. Embolization therapy injects tiny particles into the arteries feeding tumors to cut off their blood supply which may help improve outcomes by preventing blood loss during surgery, reducing surgical times, and shrinking tumors or reducing recurrence.

OUTLINE:

Patients receive iodixanol via injection and undergo diagnostic cerebral angiogram over 30 minutes. If the tumor blood supply is suitable, patients undergo tumor vessel embolization with polyvinyl alcohol (PVA) suspended in ethiodized oil (EOV) and delivered via a catheter. Patients also undergo head and neck computed tomography (CT) scans immediately after completion of tumor vessel embolization, and again between 2-3 months later.

After completion of study, patients are followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Primary or metastatic extra-axial tumor involving one or more anatomic structures in the head and neck
* Vascular supply from one or more branches of the external carotid artery
* Planned surgical resection
* All stages
* Extra-axial head and neck tumor greater than 1 cm in any dimension
* Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the head and/or neck
* Subjects who have undergone prior therapies are eligible
* Adults aged 18-80; no data outside this age range
* Minimum of 3-month life expectancy
* Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m\^2
* Subjects must be non-pregnant at the time of angiographic intervention
* Resectable tumor as determined by the Tumor Board
* Medically stable at the time of the planned intervention, despite potential comorbidities
* In English or Spanish. All study materials have been professionally translated into Spanish

Exclusion Criteria:

* Recent hemorrhage or trauma
* Pregnancy
* Nursing mothers
* Contrast medium allergy
* Hypersensitivity or known allergy to ethiodized oil, poppy seeds, or poppy seed oil
* Uncontrolled or concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy is a contraindication to angiography outside of the emergency setting
* Active thyroid disease may be affected by iodinated products
* Subject is participating in another clinical trial at the enrollment of the study or duration of the study that can affect the treatment and outcome of the study
Adaptive Physical Activity for Chronic Stroke

This study will compare the Adaptive Physical Activity program (APA) to a less vigorous group exercise program, (Sittercise) to see if APA leads to greater improvements in walking endurance, quality of life, and participation in social activities.

The purpose of this study is to translate the Italian APA exercise model into a sustainable, evidence-based VA community program of exercise for older adults with chronic stroke. The investigators' short-term objectives are to test study hypotheses using a Randomized Clinical Trial (RCT) with an Attention Control (also referred to as the "Sittercise" exercise program). The investigators will also explore factors related to exercise adherence in a community program for chronic stroke survivors. The investigators' longer term objective is to disseminate this model to facilitate the development of a network of community-based exercise programs for older adults with chronic stroke. In the RCT the investigators propose to offer courses in Office of Aging (OoA) Senior Centers and National Rehabilitation Hospital. At the conclusion of the research study, the OoA plans to continue offering APA-stroke courses. Through partnership, the Veterans Health Administration (VHA) and the Administration of Aging (AoA) can potentially replicate this model at the community throughout the U.S. using local OoA Senior Centers and other facilities that would increase community access for Veterans.

Eligibility Criteria:
Inclusion Criteria:

* evidence of stroke (ischemic or hemorrhagic) minimum 6 months prior in men or women ages 40 or older;
* residual hemiparetic gait deficits;
* already completed all conventional inpatient and outpatient physical therapy;
* ability to rise from a chair unaided and without an assistive device

Exclusion Criteria:

* cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure (NYHA category II or higher);
* orthopedic, circulatory, or chronic pain conditions restricting exercise;
* active cancer; poorly controlled hypertension ( greater than 180/100 on 2 readings separated by 5 minutes rest);
* dementia;
* severe receptive or global aphasia with inability to follow 2-step commands;
* co-morbid non-stroke neurological disorder that impairs mobility (e.g. multiple sclerosis or Parkinson's);
* untreated clinical depression;
* inability to complete the "6-Minute Walk" test during baseline testing
Angioplasty in Peripheral Arterial Disease and Endothelial Function

To investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity

Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis affecting a large proportion of the aged population. It is associated with a more or less severe impairment in functional activity and with an increased risk of future cardiovascular events. In PAD patients, an increased inflammatory status and a depressed endothelial function, assessed as flow-mediated dilation of the brachial artery have been demonstrated. Moreover, a prognostic value has been found in PAD patients for both inflammatory parameter and flow-mediated dilation (FMD). One of the reasons of the increased inflammatory activation and endothelial dysfunction in PAD patients could be the ischemia-reperfusion injury associated with intermittent claudication. The hypothesis is that repeated episodes of acute inflammation and endothelial dysfunction following ischemia-reperfusion injury linked to intermittent claudication could be in part responsible for the increased inflammatory status and chronically depressed endothelial dysfunction of these patients. Taking into account these considerations, it is reasonable to assume that the correction of leg ischemia by interventional procedure, such as peripheral transluminal angioplasty (PTA) should determine a reduction in inflammatory mediators and an improvement in endothelial function.

The study is a prospective, open, randomised, controlled, single-centre, follow-up evaluation, assessing the efficacy of peripheral catheter interventions in patients with symptomatic PAD on endothelial dysfunction and plasmatic procoagulant activity. Patients will be randomly assigned to immediate revascularization or to no treatment for one month. The assessment of parameters (brachial artery flow-mediated and nitrate-mediated dilation, plasma levels of C reactive protein, fibrinogen, microparticles and coagulation factors) will be performed at baseline and after 4 weeks in both, patients undergoing interventional procedures and in those, who will not be treated.

Eligibility Criteria:
Inclusion Criteria:

* Peripheral arterial disease
* femoro-popliteal lesion
* successful endovascular treatment of lesion

Exclusion Criteria:

* persistent claudication after revascularization in arm A
* inflammatory or neoplastic disease
* pregnancy
Lay-Led Smoking Cessation Approach for Southeast Asian Men

To develop a scientifically valid and ethnically approved, lay-led smoking cessation intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.

BACKGROUND:

Economically disadvantaged Southeast Asian men were targeted because of their higher than average smoking prevalence rate, their extraordinary increased numbers, and the relative paucity of strategies to reach this hard-to-reach group.

DESIGN NARRATIVE:

Trained, lay S.E. Asian counselors (cadre) were the primary agents for this study's assessment, intervention, and follow -up of smoking cessation behaviors. Seven reasons for using this approach were cited, including the potential generalization of this approach to other populations.

Over the six year demonstration and education research study period, the investigators: collected baseline data on smoking and smoking cessation behaviors; designed ethnically approved strategies for the cessation and maintenance of smoking cessation behaviors based upon findings from the baseline assessment; implemented ethnically approved strategies for smoking cessation; maintained smoking cessation after initial quitting; and evaluated the effectiveness of the intervention.

On the macro level, an equal number of randomly selected subjects (E1) allocated equally among the three ethnic groups in one county were compared to an equal number of control subjects in geographically separate counties. On the micro level, E1 subjects were also compared to control subjects (C1) in the intervention county. All subjects were longitudinally followed. The standard for successful cessation was biochemically verified through salivary cotinine tests at one year of self-reported abstinence.

Among the study's features were the community-based (versus academic or clinical) nature of lay change agents, the deliberate integration of baseline data and scientific principles with ethnic values in the intervention approach, and a research design that allowed for both macro and micro comparisons of the intervention with control conditions.

Eligibility Criteria:
No eligibility criteria
Atrial Fibrillation in Turkey: Epidemiologic Registry-2

Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and associated with increased cardiovascular morbidity and mortality. Our previous AFTER study demonstrated the general epidemiological data about the patients with valvular and nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management modality in our country. In this multicenter trial the investigators aimed to analyze, follow and evaluate the epidemiological data in non-valvular AF patients.

Atrial fibrillation (AF) is the most common cause of preventable stroke and strongly associated with increased cardiovascular morbidity and mortality with a prevalence of 1-2% in general population.The first multicenter trial in AF patients in our country, Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER) study, showed that 40% of non-valvular AF patients were on warfarin therapy with an effective INR rate of 37% and the most frequent cause of warfarin underuse was physician neglect. Yet, the use of new oral anticoagulants, time in therapeutic INR range (TTR) in warfarin users and the main management modality (rhythm or rate control) in AF patients have not been studied in Turkey. Therefore, in this multicenter trial, we aimed to assess the extent of effective anticoagulant use (by means of TTR) and epidemiological characteristics of the nonvalvular AF patients with the use of new oral anticoagulants (NOACs) in clinical practice in addition to increased awareness provided by AFTER study.

AFTER-2 study is planned as a prospective, observational and multicenter study with a 6 month and 1-year follow-up of the patients. A total of 4100 patients in 42 centers reflecting the population of the twelve regions of our country according to the Nomenclature of Territorial Units for Statistics will be included in the study.

The detailed characteristics of the patients with non-valvular AF, the rates and kind of oral anticoagulant use, the effect of increased awareness and NOACs on anticoagulant use rate, TTR in warfarin using patients and the bleeding risks of the patients will be determined in this study. At the end of the study, we will question the patients in terms of major adverse events and analyze the independent predictors of these events.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult non-valvular AF patients applied to the cardiology clinics with at least one attack of AF identified on electrocardiography without rheumatic mitral valve stenosis and prosthetic valve disease

Exclusion Criteria:

* Patients who will refuse to be a participant or will not sign the consent form
Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism

OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in various hypertensive populations and screen at risk members of GRA pedigrees.

II. Investigate other factors regulating blood pressure in GRA (environmental, genetically determined factors).

III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA.

IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected patients with MRI angiography for intracranial aneurysm.

PROTOCOL OUTLINE:

Patients are screened for high blood pressure, suppressed plasma renin activity level, and low potassium levels. Urine is collected for a 24 hour period. Blood specimen is collected for molecular biologic evaluation for the presence of the chimeric gene diagnostic of GRA. Any history of cardiovascular events is recorded.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosed glucocorticoid-remediable aldosteronism (GRA) with hypertension Hypokalemia is variably seen Blood pressure variably elevated Elevated level of aldosterone Low level of plasma renin activity
Normative Data for the Qmci-TW in a Taiwanese Sample

Many perioperative factors have been pointed out as the risk factors for postoperative cognitive dysfunction, which may occur immediately after the surgery, days after the surgery, or months after the surgery. Quick mild cognitive impairment screen (Qmci) is a sensitive and specific test to differentiate mild postoperative cognitive dysfunction. However, the learning effect have been raised as a bias when we repeated the same test for one person at different timing. Thus the study is designed to collected the Normative Data in series for the Qmci-TW in a Taiwanese Sample.


Eligibility Criteria:
Inclusion Criteria:

* adults no less than 20years old

Exclusion Criteria:

* pregnant women
* patients with respiratory failure \[forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) \< 70 % and FEV1 \< 50%\]
* patients with heart failure(NYHA score =III、IV)
* patients with chronic kidney disease (eGFR\< 60 ml.min-1.1.73m-2)
* patients with liver failure
* patients with ongoing infection
* patients have surgery or hospital admission in the past half year
A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia

The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD).

In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated.

In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated.

Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days.


Eligibility Criteria:
Main Inclusion Criteria:

Part 1\& Part 2

* Subjects aged from nine to 17 years (from nine to 14 years in Part 1), on the day the informed consent is signed.
* Subjects with a diagnosis of FD as defined by the Rome IV Criteria.
* Subjects who have postprandial fullness, upper abdominal bloating or early satiation.

Part 2 only

* Subjects who have postprandial fullness, upper abdominal bloating or early satiation during with a certain severity during a week prior to the day of randomization.

Main Exclusion Criteria:

Part 1\&Part 2

* Subject who have organic diseases of the gastrointestinal tract or gastrointestinal bleeding within 24 weeks prior to informed consent.
* Subject who have received Helicobacter pylori eradication therapy within 24 weeks prior to informed consent, or subjects who is defined as Helicobacter pylori-positive within 4 weeks prior to or on the day the informed consent is signed.
* Subjects who have alarm symptom on the day the informed consent is signed.
* Subjects who have food allergy of unknown origin or uncontrolled food allergy.

Part 2 only

* Subject taking drugs used for FD within 2 weeks prior to the day of randomization (excluding proton pump inhibitors)
* Subject taking proton pump inhibitors within 4 weeks prior to the day of randomization.
Skin Biopsies and DNA Analysis in Patients Receiving Irinotecan or Gemcitabine For Advanced Solid Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This laboratory study is collecting skin biopsy specimens from patients receiving irinotecan or gemcitabine for advanced solid tumors and using them to study change in DNA due to this treatment.

OBJECTIVES:

Primary

* Determine the level of p-Chk1 and phospho-histone 2AX (p-H2AX), an indicator of DNA damage, and possibly downstream pathway markers in hair follicles from skin biopsies of patients treated with gemcitabine hydrochloride or irinotecan hydrochloride for advanced solid tumors.

Secondary

* Characterize the method for measurement (immunohistochemistry).
* Measure inter- and intra-patient variability for the biomarker.
* Partially characterize the dynamic time course of p-Chk1 and p-H2AX after administration of a DNA-damaging agent.

OUTLINE: This is a multicenter study.

Patients undergo collection of 2 skin biopsies with hair follicles at 4 and 8 hours or at 4 and 6 hours after the start of irinotecan hydrochloride or gemcitabine hydrochloride treatment on day 1 of course 1. Repeat biopsies will be taken at 4, 6, or 8 hours after the start of irinotecan hydrochloride or gemcitabine hydrochloride on day 1 of 2 successive courses.

Tissue is examined by immunohistochemistry and possibly other methods for changes in p-Chk1 and pH2AX.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced solid tumor malignancy (preferably colorectal, pancreatic, or breast cancer)
* Scheduled to receive a standard dose, weekly regimen of either irinotecan hydrochloride or gemcitabine hydrochloride

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No DNA-damaging agent within the past 13 days
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.

Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.


Eligibility Criteria:
Inclusion Criteria:

* Age : from 18 to 75 years
* Neurological signs evoking cerebral ischemia

Exclusion Criteria:

* Severe hypoxemia (PaO2/FiO2 \< 200) with controlled ventilation (FiO2: 100%)
* Hypothermia \< 36°C
* Obesity (BMI ≥ 40) with documented hypopnoea
* Intractable hypotension despite optimal filling and catecholamine doses \> 1µg.Kg.min
* Patients with contraindication for organs harvesting.
* Documented chronic respiratory failure
* Progressive infectious acute respiratory disease
* Family opposition to subject's participation in the study