cyrilzakka/clinical-trials huggingface dataset:
Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

OBJECTIVES:

* To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).

OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder
* Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1

PATIENT CHARACTERISTICS:

* Previously consented to biologic studies

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

Through this study, the investigators hope to be able to understand:

1. The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...).
2. Pancreatic trauma management in Belgian hospitals according to severity grade.
3. Short- and medium-term complications associated with the trauma
4. Long-term complications of trauma on growth and on the endocrine and exocrine function of the pancreas.

On the basis of all the information collected, the investigators hope to be able to provide indicators on the epidemiology of pancreatic trauma in children, short-term risks as well as nutritional and functional risks, taking into account the initial management of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Child aged ˂18 years at the time of the trauma
* Child regularly followed in paediatric gastroenterology consultation
* Positive history of pancreatic trauma
* Child with at least one blood lipase measurement
* Child with at least one pancreatic imaging available

Exclusion Criteria:

* age \>18 years
A Phase 1 Study of XL019 in Adults With Polycythemia Vera

The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a diagnosis of polycythemia vera (PV), and has failed, or is intolerant of, standard therapies or refuses to take standard medications.
* The subject is ≥18 years old.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* The subject has adequate organ function.
* Subjects who have received phlebotomy due to PV must have documented phlebotomy history for 12 weeks prior to enrollment.
* The subject has the capability of understanding the informed consent document and has signed the informed consent document.
* Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative pregnancy test at screening.
* The subject has had no other diagnosis of malignancy or evidence of other malignancey for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).

Exclusion Criteria:

* The subject has received treatment for PV within 14 days prior to first dose of XL019
* The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
* The subject is pregnant or breastfeeding.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Advancing the Standard of Care for Pin Site Care

The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.

Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.

Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent has been obtained from the subject.
* Subject is able and willing to comply with study procedures.
* Subject is 18 years of age or older.
* Type I or II Diabetes
* Albumin \>2.5
* A1C\<12 or average fasting levels \<200
* ABI \> .6 or biphasic pedal vessels by Doppler
* Charcot arthropathy of lower extremity

  * Foot/ankle deformity
  * Foot/ankle fracture
* Subject will undergo an Open Reduction with External Fixation (OREF).

Exclusion Criteria:

* A1C \> 12
* ABI \< .6 or monophasic pedal pulses on Doppler
* Recent (\<2 months) or ongoing bone infection based on radiograph or scan
* Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers
* Honey or honey based allergy
Hair Cycle Modulation To Promote Human Wound Healing

Chronic wounds represent a huge burden to both patients and the National Health Service (NHS), with over 200,000 sufferers in the UK alone. Based on current conservative estimates the NHS spends £2.3 - £3.1 billion pounds every year treating these patients.

This study aims to reduce this shared burden, preliminary data from our research group using animal models has demonstrated variable ability of hair follicles to heal wounds based upon their stage within their growth cycle. This currently proposed study therefore aims to perform a simple novel intervention on patients prior to their elective surgery in an effort to replicate the substantial healing abilities noted in the animal models.

Under normal circumstances, a patient's operative site is shaved prior to the surgery for hygiene and visual simplicity. The aim of this study is to wax 50% of the patient's operative site prior to their surgery, the other half will be shaved on the day of surgery as per normal surgical protocol. Based on known data this waxing technique will cycle the hair follicles into their growth phase at the time of surgery. The growth phase of hair follicles corresponds with an increased ability to heal due to recruitment of a patients own stem cells. This study therefore aims to take advantage of the patient's own stem cell population. The 50% waxing and 50% shaving method upon each patients donor site allows us to directly compare the influence of these two methods directly on a patient-by-patient basis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing skin graft surgery
* Patient is 18 years of age or older.
* Written and informed consent provided.

Exclusion Criteria:

* Participants that have been enrolled in a clinical trial within the last 3 months that would affect their ability to heal or influence hair cycle.
* Specific hair-linked diseases, e.g. alopecia areata. (Not including androgenetic alopecia)
* Lack of capacity to consent
* Lymphedema
* Malnutrition
* Collagen disorders
* Patients requiring grafts smaller than 5cm x 5cm
* Patients requiring grafts wider than 10cm
* Immunomodulation drugs
* Patients will be excluded mid study if they develop an infection that prevents biopsy retrieval
Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement

Fibromyalgia is a syndrome (set of symptoms) of unknown etiology and characterized by diffuse musculoskeletal pain and chronic fatigue. In addition, other symptoms such as cognitive alterations, sleep rhythm disturbances, psychiatric syndromes such as anxiety, depression, etc. Other very characteristic symptoms are hyperalgesia (very low pain threshold) and allodynia (amplified response to painful stimuli).

The treatment of fibromyalgia is symptomatic and the drugs only serve to reduce symptoms in some patients, in addition to the fact that these available treatments (antidepressants, pain signal modulators, rescue analgesics, etc.) have many side effects.

The food supplement which is the object of this study, FibrofixPlus®, is made up of a combination of natural substances.

This is the reason why this observational study aims to improve symptoms caused by fibromyalgia in patients treated with FibrofixPlus®.

Patients who meet the fibromyalgia criteria according to the definition of the American College of Rheumatology (ACR) in 1990 and 2010, with a minimum score of 4 on the Visual Analogue Scale (VAS) of Fatigue and Pain and without any treatment (anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics) in a minimum of 4 weeks prior to the beginning of the study, with some exceptions, and who do not meet any of the exclusion criteria will be invited to participate in the study.

There are three study visits which are distributed throughout 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years.
* Meet the fibromyalgia criteria according to the definition of the American College of Rheumatology of 1990 and 2010.
* Minimum score of 4 on the Visual Analogue Scale (VAS) for Fatigue and Pain.
* Period prior to the start of the study of a minimum of 4 weeks without treatment with anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics. The use of paracetamol up to 2 g/day is allowed, and tramadol 100 mg/8h maximum.

Exclusion Criteria:

* Current diagnosis of a psychiatric disorder other than major depressive disorder.
* Pain caused by a traumatic or structural injury.
* Chronic inflammatory diseases.
* Autoimmune disease.
* Use of medications that may interfere with the assessment of pain improvement, including analgesics (with the exception stated in the inclusion criteria), antidepressants, anticonvulsants, or other medication taken to combat fibromyalgia, fatigue or pain.
* Rehabilitation with therapeutic intent.
* Intent to apply or current disability application process.
* Natural therapies (homeotherapy, acupuncture, food, etc.) to improve fibromyalgia.
* Hypersensitivity to the active principles or to any of the excipients of the products included in the study.
* Pregnancy.
* Breastfeeding.
Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality.

The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation.

In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone.

Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments.

The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs.

Patients \>_65 years were significantly more likely to progress to persistent AF/AT than patients were \<65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression.

So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.


Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, trans-telephonic monitoring (TTM) or Holter monitor (episodes of AF must be \>30 seconds in duration to qualify as an inclusion criterion)
* Age of 18 years or older on the date of consent.
* Candidate for ablation based on AF that is symptomatic
* Informed Consent

Exclusion Criteria:

Permenant AF

* Previous left atrial (LA) ablation or LA surgery
* AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
* Active intracardiac thrombus
* Pre-existing pulmonary vein stenosis or pulmonary vein stent
* Contraindication to anticoagulation or radiocontrast materials
* Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
* Cardiac valve prosthesis
* Severe mitral valve regurgitation or stenosis
* Myocardial infarction, percutaneous intervention, or coronary artery stenting during the 3-month period preceding the consent date
* Cardiac surgery during the three-month interval preceding the consent date
* Significant unrepaird congenital heart defect (including patent foramen ovale)
* NYHA class IV congestive heart failure
* Significant chronic kidney disease (eGFR \<30 mL/min/1.73m2)
* Cerebral ischemic event (stroke or transient ischemic attack) during the six-month interval preceding the consent date
* Pregnancy and Life expectancy less than one year
Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

The overall objectives of the proposed research are to: (i) develop a prototype of a smartphone application (app) that can deliver culturally adapted STAR-C training to Latino caregivers, and (ii) understand the extent to which a STAR-C app is acceptable and potentially effective among Latino caregivers. Achieving these objectives will lay the groundwork for a future full-scale trial to test the STAR-C app with Latino caregivers.

This study aims to: Adapt the STAR-C training to increase cultural relevance for Latino caregivers. The adaptations will focus on incorporating cultural examples, identities, values, beliefs, and practices within the training, as well as using cultural idioms, metaphors, and sayings to compliment explanations. Develop a prototype of a STAR-C app for Latino caregivers. The prototype will be iteratively developed with active participation from Latino caregivers. The final prototype will consist of a fully interactive app that delivers culturally relevant STAR-C training in an engaging and easy to use format. Assess the acceptability and potential effectiveness of the STAR-C app for Latino caregivers. Measures of acceptability will include app usage and perceived ease-of-use and usefulness of the STAR-C app. Measures of potential effectiveness will include changes in caregiver burden and depression.

For aim 1, the investigators plan to recruit 25-30 participants with representation from both caregivers and providers. The investigators will recruit Latino Family Caregivers of persons with ADRD (Alzheimer's Disease and related Dementias). The investigators will recruit providers who work in an organization serving Latino elderly. Participants will be \>18 years old.

For aim 2, the investigators will recruit 5 caregivers per session. With three iterative design sessions, the investigators anticipate 15 caregivers in total. The investigators will use the same eligibility criteria described for aim 1.

For aim 3, the investigators will recruit 15 Latino caregivers for each study arm (total sample size of 30). The investigators based the sample size on a rule of thumb of 12 to 15 participants per group for pilot studies. The investigators will use the same eligibility criteria and recruitment strategy described for aim 1

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Family member or close friend of a person with ADRD
* Provide at least eight hours of care per week Speak English or Spanish
* Self-identify as Latino.

Exclusion Criteria:

* Caregiver who has a diagnosis of ADRD
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
* Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
* Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
* MRS total score \< 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
* DSS score \< 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
* CGI-S score \< 3 on two consecutive ratings, separated by at least five days (Screening and Day 1)
* Serum valproate level \> 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening
* Olanzapine dose between 5 and 20 mg/day at Screening

Exclusion Criteria:

* History of schizophrenia or schizoaffective disorder
* Axis I (e.g., anxiety disorder) or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
* Has first manic episode after age 60
* Has ever taken clozapine
* Has received depot neuroleptic medication within six months of randomization
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of active alcohol or substance abuse/dependence within 90 days prior to Screening
* Known history of non-response to either Depakote or olanzapine monotherapy for the treatment of bipolar disorder
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis

A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old and ≤80 years old
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
* The length of target lesion less than 20 cm
* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion Criteria:

* The plasma creatinine level is higher than 150 umol/L
* Thrombolysis or thrombectomy is required
* There are more than 2 lesion need to treat in the target vessel.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation.
* The patient had outflow less than 1 vessel
* The lesion located in a stent.
* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
* Women who are pregnant or breast-feeding.
* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
* Patient has life expectancy of less than 12 months.
* The investigator think the patient is not suitable for participation in the clinical trial.