cyrilzakka/clinical-trials huggingface dataset:
Assessing Immune Function in Young Patients With Cytopenia That Did Not Respond to Treatment

RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment.

OBJECTIVES:

Primary

* To evaluate the value of TCR V beta repertoire analysis for the determination of autoimmunity in refractory cytopenia (RC).
* To evaluate which immunophenotypic hematopoietic subclones are associated with oligoclonal T-cell expansion in RC.
* To evaluate the presence of paroxysmal nocturnal hemoglobinuria (PNH) clones in RC.

Secondary

* To compare the molecular response with the hematologic response in patients with RC after treatment with immunosuppressive therapy (IST).
* To compare the molecular response with human leukocyte histocompatability antigen (HLA) expression in patients with RC after treatment with IST.

OUTLINE: This is an open-label, multicenter, nonrandomized, prospective study.

Patients undergo biopsy, bone marrow, and blood sample collection periodically for immunological studies. Samples are analyzed for TCR V beta repertoire and paroxysmal nocturnal hemoglobinuria (PNH) clone analysis via PCR heteroduplex analysis and immunophenotyping of CD14, CD16 , CD55, CD59, and CD24 expression via flow cytometry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of refractory cytopenia (RC) including any of the following:

  * Severe aplastic anemia (SAA)
  * Fanconi's anemia
  * Shwachman Diamond syndrome
  * Dyskeratosis congenita
  * Pearson syndrome
* All RC patients included in the EWOG MDS 2006 protocol irrespective of therapy
* Patients who have undergone hematopoietic stem cell transplantation (HSCT) may be enrolled on EWOG-MDS SCT RC RIC 06 or EWOG-MDS SCT MDS 06 protocol

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior immunosuppressive therapy for refractory cytopenia
Reducing Pain of Lidocaine Injection

The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.


Eligibility Criteria:
Inclusion Criteria:

* 21 Years of age
* Any patient scheduled for a breast biopsy at Duke Breast Interventional Imaging

Exclusion Criteria:

* Less than 21 Years of age
* Allergic to Lidocaine or Sodium Bicarbonate
* Not mentally capable of consenting
Nocturnal Enuresis and Rapid Maxillary Expansion

Nocturnal enuresis (NE) is the involuntary loss of urine that occurs only at night in children aged 5 years or more.

NE is a common problem, affecting about 10% of school children. The prevalence declines with each year of maturity but for some it persists in to adolescents and early adulthood. It can lead to bad self-confidence and low self-esteem, which can have psychosocial consequences.

NE is a multifactorial condition. Three central factors have been identified:

A) Many bedwetting children produce large amounts of urine at night due to a deficiency of the antidiuretic hormone vasopressin.

B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all children are deep sleepers with high arousal thresholds. They simply don't wake up when the bladder is full or when it contracts.

There are two well established and evidence based treatments today: the bed-wetting alarm and the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets the bed, which conditions the child to wake up or inhibit bladder emptying. This method is curative for about half of the patients who try this, but relapse occurs. Desmopressin is a synthetic analog of arginine vasopressin and works by decreasing the urine volume at night. About half of the patients become dry with this medication but only as long as they take the medicine. To day, at least 25% of all children with NE do not respond to any of the above treatment.

Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is activated twice every day for 10-14 days. The procedure is neither painful nor harmful and is not very visible at all.

There are a few reports about children who have become dry after RME treatment. None of them have been randomised or placebo controlled but indicates that quite a few children do become dry after this treatment. A recently carried out study in Sweden show that half of the children became dry after RME treatment. These children were all classed as therapy resistant and had already tried the alarm and medication without success.

The reports are intriguing, but invite the question why a brace would help cure NE? It is likely that sleep and respiration is involved. This study will investigate these children's sleep during the treatment. The trial is a randomised, placebo controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 7-14 years old
* At least 7 wet nights out of 14

Exclusion Criteria:

* Daytime incontinence
* Constipation
* ADHD
BRAF V600E and Redifferentiation Therapy in Radioiodine-refractory Papillary Thyroid Cancer

Papillary thyroid cancer (PTC) is the most common neoplasia in the thyroid gland. The combination of surgery, followed by radioiodine therapy (RIT) and thyroid-stimulating hormone (TSH) suppressive therapy is usually a curative option for differentiated thyroid cancer (DTC). Although DTC has a good prognosis generally, it is problematic when dedifferentiation is suspected and radioiodine refractoriness presumed. One possible therapy option for redifferentiation is the pretreatment with retinoids. From 2008 to 2014 there were 13 patients with PTC who were treated with retinoids after thyroidectomy before a further course of radioiodine. A recent study has shown that the efficacy of Selumetinib, another option for redifferentiation depends on the mutational status of the treated patient. In this retrospective study the investigators looked for a similar association between BRAF V600E and redifferentiation therapy with retinoids. As retinoids have fewer side effects compared to TKI, it is worth performing studies to assess the importance of genetic marker for the response and to estimate the chances of this specific patient collective. BRAF V600E seems to be associated with better long-term response after redifferentiation therapy with 13-cis RA in RAI-R PTC. Therefore, evaluation of BRAF mutational status prior to redifferentiation therapy could be beneficial for predicting response.


Eligibility Criteria:
Eligible criteria for radioiodine-refractory patients included:

* PTC
* no response to former RIT
* decrease or loss of initial sufficient RI-Uptake
* redifferentiation therapy with 13-cis-RA
* available FFPE tissue.

Eligible criteria for radioiodine-sensitive patients included:

* PTC
* cured after a maximum of two RIT
* no redifferentiation therapy necessary
* available FFPE tissue.

Exclusion criteria

* DTC other than PTC
* patients lost to follow-up
* other redifferentiation therapy than retinoids
* anaplastic or medullary thyroid cancer
* benign thyroid disease, no available FFPE tissue
* more than two RITs in the control group
* insufficient clinical information.
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: a Prospective Registry with Central Echocardiography Analysis.

The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
* Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.

VARC-3- defined technical success defined as:

* Freedom from mortality
* Successful access, delivery of the device, and retrieval of the delivery system
* Correct positioning of a single prosthetic heart valve into the proper anatomical location
* Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.

Exclusion Criteria:

* Age \>80 years
* Severe pulmonary disease (FEV1 \<50% predicted or need for home oxygen)
* Severe renal dysfunction (eGFR \<30 ml/min/1.73m2)
* Frailty (Clinical Frailty Scale \> 4)
* Severe coronary disease (SYNTAX score \>32)
* Left ventricular ejection fraction ≤30%
* Moderate-to-severe mitral regurgitation
* Severe tricuspid regurgitation
* Pulmonary systolic pressure \>60 mmHg
* STS-PROM \>5%
* Any disease leading to a life expectancy \<5 years
Diabetes Medication Choice

The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.


Eligibility Criteria:
* Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required
* Use 1 or 2 oral hypoglycemic agents; not using insulin therapy
* Are not pregnant
* Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%
* Recognize their primary care provider as their main diabetes care provider
* Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)
* Have no plans to relocate out of town in the next 6 months
* Enrolment is open to males and females of diverse racial backgrounds
Dry Cupping Therapy in Knee Osteoarthritis

Introduction: Knee osteoarthritis (KOA) is the biggest cause of pain and disability worldwide. As a non-pharmacological approach, ventosatherapia has been used to control pain, improve function and quality of life. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. Objective: To evaluate the effects of dry cupping on pain, function and quality of life in women with KOA. Methods: This is a randomized, blinded placebo-controlled protocol. 62 women diagnosed with KOA will be recruited, based on the clinical criteria of the American College of Rheumatology, who will be randomly divided into two groups (31 per group): dry cupping and dry cupping sham.

The intervention will be carried out for 15 minutes, twice a week, for 6 consecutive weeks, totaling 12 sessions. Both groups will be evaluated in 4 moments: before the intervention (T0), after 3 weeks of interventions (T3), at the end of the protocol (T6) and 4 weeks after the end of the interventions (follow-up - T10). The analyzed outcomes will be: Primary - pain (numerical pain scale); Secondary - Physical function (WOMAC; tests of going up / down stairs, brisk walking in 40 m and sitting / rising from a chair in 30 s), quality of life (SF-36) and global perception of the effect

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with KOA based on ACR clinical criteria;
* Knee pain intensity between 3 and 8, according to the Numerical Pain Scale (END);
* BMI less than 35 kg / m2.

Exclusion Criteria:

* Having undergone physical therapy treatment for the knee in the 3 months prior to the project;
* Be engaged in\> 45 minutes / week in accumulated physical activity of at least moderate intensity;
* To have been submitted to the application and / or intervention with the wind therapy previously.
* Have used corticosteroid infiltration in the knee in the last 6 months;
* Present any medical restrictions that make it impossible for them to participate in the proposed assessments and interventions (cardiorespiratory, neurological and / or musculoskeletal changes);
* Presenting a diagnosis of fibromyalgia, rheumatoid arthritis or some systemic inflammatory arthritis;
* Presenting a ligament or meniscal injury diagnosed clinically or with a positive result in the Apley tests or anterior / posterior drawer;
* Have had previous surgery on the ankle, knee or hip;
* Present a clinical diagnosis of some dementia or inability to answer the questionnaires related to the study;
* Present any contraindications for the use of ventosatherapia (skin lesion in the region where it will be applied, cancer, kidney failure, liver and heart failure, pacemaker, pregnancy);
* Having uncontrolled diabetes and hypertension;
* Have a trip scheduled for the two months following inclusion in the survey.
Evaluation of the Safety and Tolerability of Exogenous Ketosis Induced by Free Beta-hydroxybutyrate.

The goal of this clinical trial is to evaluate the safety and tolerability of free beta-hydroxybutyrate induced ketosis in healthy individuals. The main question it aims to answer is:

* Is free beta-hydroxybutyrate safe and well tolerated by adults?

Participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with Stevia, every morning between 9:00 and 11:00 for four weeks.

Several ketogenic interventions have shown benefits in a wide variety of clinical scenarios. Ketosis can be induced in different ways: by 72 hours of fasting, with a carbohydrate-restricted diet and with supplements. For emergency situations, such as heart failure, the first two options are not an option for patients as they cannot wait 72 hours.

There are 3 safe supplements for inducing ketosis: ketone salts, ketone esters and medium-chain triglycerides. Even though they all raise the beta-hydroxybutyrate serum concentration, they significantly differ in safety profiles, drug vehicles, palatability and monetary costs. A biologically identical beta-hydroxybutyrate supplement with prompt onset of action and free of salt, alcohol and drug vehicles would be an adequate option in many clinical settings.

A gender and age-balanced adult sample will be recruited in order to evaluate the safety and tolerability of free beta-hydroxybutyrate. Participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with Stevia, every morning between 9:00 and 11:00 for four weeks. Symptoms will be evaluated on a daily basis with a self-administered opened questionnaire. A venous blood gas analysis will be made at the beginning, 2 and 4 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic adults who have not been diagnosed with chronic degenerative diseases or diseases that cause acid-base imbalances.
* Regarding women of childbearing age, it will only be recruited those who are using a method of contraception including oral contraception, contraceptive implant, contraceptive injection, intrauterine device (IUD) or patch.
* Adults without cognitive impairment that can compromise decision making.

Exclusion Criteria:

* Scheduled surgery during participation period.
* Adults on a ketogenic diet, carbohydrate-restricted diet or intermittent fasting.
* Women with a positive HCG serum or urine pregnancy test.
Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures

The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.

Inclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Exclusion Criteria

1. Age under 19 years
2. Pregnant women will be excluded. This will be confirmed by self-report

Eligibility Criteria:
Inclusion Criteria:

* All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)

Exclusion Criteria:

* Age under 19 years
* Pregnant women will be excluded. This will be confirmed by self-report
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers

The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.

Exclusion Criteria:

* concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.

To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. We want to know, compared to only routine education, if adding digital video disk could decrease parental uncertainty or anxiety more or not.

Aims and objectives: To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur.

Background: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above.

Design: A randomized control-group pretest-posttest design. Methods: In a teaching hospital, 50 fathers and 50 mothers whose children (n=50) underwent first elective catheterization for congenital heart disease were randomly divided into group 1: 25 fathers and 25 mothers receiving routine education plus digital video disk before catheterization; and group 2: 25 fathers and 25 mothers receiving routine education before catheterization. Between groups, parental uncertainty and anxiety levels were compared (1) before education, (2) after education (before catheterization) and (3) on the discharge day (after catheterization). Among mothers whose children had catheterization or post- catheterization complications, the effect of watching the digital video disk on uncertainty and anxiety at discharge day was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Parents whose children underwent first elective cardiac catheterization for congenital heart disease
* Parents should have been the primary caregivers
* Parents able to communicate effectively, either orally or in writing

Exclusion Criteria:

* Parents of children with genetic disorders
* Parents of children with non-cardiac congenital anomalies
* Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases
Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder

Children who have parents with bipolar disorder are at risk for developing anxiety disorders.

Children who have parents with bipolar disorder are at risk for developing anxiety disorders. Typical treatments for anxiety in children are SSRI antidepressants. However, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. Studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. These studies can also help with early intervention and possible future prevention strategies for bipolar disorder. This study involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.

Eligibility Criteria:
Inclusion Criteria:

* 10-17 years old
* At least one parent with bipolar disorder
* Meets clinical criteria for a specific anxiety disorder
* PARS -5 item scale score \> 10 at screening and baseline of initial study phase
* Fluent in English;
* Provision of written informed consent/assent
* Agrees to participate in 75% of sessions

Exclusion Criteria:

CANNOT Have any of the Following:

* Documented diagnosis of mental retardation or IQ \<70
* Previous participation in mindfulness-based treatment
* Substance use disorder within last 3 months
* Judged clinically to be suicide risk
* Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details)
* Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation
* Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder
* Any symptom that requires admission to an inpatient psychiatric unit
* Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol