Kornimate/medical-research-clean huggingface dataset:
observation of patients with transfusional hemosiderosis treatment with deferasirox

Conditions: Transfusional Hemosiderosis

Summary: this study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.


Eligibility criteria:
inclusion criteria: -patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information. (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring. exclusion criteria: * patients with non-transfusional hemosiderosis * patients treated with deferasirox in an interventional clinical trial other protocol-defined inclusion/exclusion criteria may apply.

Keywords: iron overload iron chelation deferasirox observational
clinical evaluation of a point-of-care (poc), covid-19 rapid antigen test (covidx™)

Conditions: SARS-CoV-2; Covid19

Summary: prospective study that will evaluate the clinical agreement of the covidx™ rapid antigen test compared to sars-cov-2 rt-pcr.

all patients who present with covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (np) collected for sars-cov-2 rt-pcr with eua as per standard of care and nasal swab collection for covidx rapid antigen testing.

Eligibility criteria:
inclusion criteria: * nasopharyngeal swab collected for sars-cov-2 rt-pcr with eua as per standard of care within 3 hours of covidx rapid antigen swab collection * first onset of covid-19-like symptoms within the last 5 days * ≥ 1 year of age * signed informed consent exclusion criteria: * unable or unwilling to provide signed, informed consent * less than 1 year of age * sars-cov-2 rt-pcr collection that occurred \> 3 hours from covidx rapid antigen swab collection * first onset of covid-19-like symptoms occurring more than 5 days from study visit * invalid or missing pcr test results * use of a non-high-sensitive sars-cov-2 test as the qualifying sars-cov-2 rt-pcr test (e.g., abbott id now, rapid antigen tests, tests that do not have fda eua, a test that was not approved by sponsor for use in the study) * enrollment in another study involving the collection of a nasopharyngeal or nasal swab * receipt of a covid-19 vaccine or participation in a covid-19 vaccine study

Keywords: antigen rapid point of care testing
simplified negative pressure wound therapy

Conditions: Wounds

Summary: the objective of this study is to implement a simplified negative pressure wound therapy (snpwt) device in a low resource setting. the investigators hypothesize that the snpwt device is at least equivalent to commercially available npwt devices. therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the snpwt device and 2. the adverse events associated with the snpwt device.


Eligibility criteria:
inclusion criteria: * open wound appropriate for npwt * wound size greater than 2 cm2 and less than 150 cm2 * adequate adjacent intact skin for application of snpwt * adequate contour of wound location for application of snpwt * patient is expected to tolerate change of the npwt dressing with the chosen analgesia and sedation plan by the treating physician * the patient is expected to remain clinically stable for the duration of the study * the patient is to remain hospitalized for the duration of the study * patient or their legal representative is willing and able to sign an irb-approved informed consent * patient less than 21 years old is willing to sign an approved assent form if able to sign exclusion criteria: * exposed blood vessels * ischemic wound * wound with necrotic tissue requiring further debridement at the time of enrollment * infection * acute osteomyelitis * malignancy in the wound * latex or rubber containing product sensitivity

Keywords: wound negative pressure wound therapy non-powered negative pressure wound therapy
depression screening in primary care: using hit for patients with limited english

Conditions: Depression; Post-Traumatic Stress Disorder

Summary: this study assessed the potential of health information technology (hit) to improve the screening, diagnosis, and treatment of depression and post-traumatic stress among lep southeast asians. should this intervention be found to be effective, the principles of the hit technology could be easily adapted for screening in other languages to increase the recognition and treatment of depression and ptsd in primary care settings.

the prevalence of depression in primary care is high. primary care physicians serve as the initial point of contact for most patients with depression, yet it is estimated that only about half of the depressed patients who present for care are recognized and treated. language barriers can further exacerbate this problem. approximately 54 million people in the united states speak a language other than english at home and over 21 million are limited english-language proficient (lep). language barriers may result in less discussion about patients' mental health needs and fewer referrals to specialty mental health services. recent advances in health information technology (hit), however, may facilitate novel ways to screen for mental health problems among limited english proficient patients. the hit intervention is a provider-level intervention that consists of four components: 1) web- based training for the providers; 2) multimedia electronic screening of patients for depression and ptsd; 3) immediate notification to the health care providers and integration with the patients' electronic health records (ehr); and 4) provider clinical decision support. in a randomized controlled trial in a primary care setting, we will assess the potential of a multi-component health information technology intervention to improve the screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder among lep southeast asians. we will examine the usability and acceptability of this technology to patients with limited english skills and their providers. finally, we will identify and evaluate potential facilitators and barriers to wide spread implementation and dissemination of the hit intervention. this technology has the potential to be adapted and utilized for any group of limited english-language proficient (lep) patients, regardless of their native language, and has the potential to be adapted for providers to aid in the recognition, diagnosis, and treatment of mental health problems in diverse primary care settings.

Eligibility criteria:
inclusion criteria: * cambodian patients over age 18 were included. exclusion criteria: * patients with severe visual/hearing impairments, major psychiatric disorders such as bipolar disorder or schizophrenia, and/or life-threatening illness, which limited their ability to consent to the study were excluded.

Keywords: depression post-traumatic stress disorder health information technology (hit) primary care provider mental health screening
a study of jnj-90189892 for relapsed or refractory acute myeloid leukemia or myelodysplastic neoplasms

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Neoplasms

Summary: the purpose of part 1 (dose escalation) of the study is to assess the effective dose (recommended phase 2 dose\[s\] \[rp2ds\]) that can be safely administered, and dosing regimens of jnj-90189892 in participants with relapsed or refractory (r/r) acute myeloid leukemia (aml) or r/r higher-risk type of myelodysplastic neoplasms (type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment). the purpose of part 2 (cohort expansion) is to further assess the safety, tolerability and efficacy in participants with r/r aml or higher-risk types of mds.


Eligibility criteria:
inclusion criteria: * have a diagnosis, per the world health organization (who) 2022 criteria, of (a) acute myeloid leukemia (aml) or (b) moderate high, high, or very high-risk myelodysplastic neoplasms (mds) per molecular international prognostic scoring system (ipss-m) * body weight that is greater than or equals to (\>=) 40 kg * have an eastern cooperative oncology group (ecog) performance status of 0 to 2 * have adequate renal function defined as chronic kidney disease epidemiology collaboration (ckd-epi) estimated glomerular filtration rate (egfr) \>=40 milligrams per minute (ml/min) computed with the calculator on the ckd-epi website * participants must have laboratory parameters in the required range exclusion criteria: * has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation * has evidence of uncontrolled systemic viral, bacterial, or fungal infection. antimicrobial prophylaxis is permitted * has known allergies, hypersensitivity, or intolerance to jnj-90189892 or its excipients * had major surgery or had significant traumatic injury within 14 days of planned first dose of jnj-90189892 * had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment * has known active central nervous system involvement
huntsman biopsy study

Conditions: Soft Tissue Sarcoma; Osteosarcoma

Summary: bone and soft tissue sarcomas are currently classified based upon light microscopy supplemented by immunohistochemistry, but within many if not all of these tumor histologic types, considerable heterogeneity exists not only in microscopic appearance but also in biologic behavior and prognosis. progress in the directed treatment of these tumors, particularly the sarcomas, awaits characterization of the gene profiles for these tumors. orthopedic oncology researchers at huntsman cancer institute at the university of utah are establishing a tumor bank for this purpose. the long term objectives of this work include: 1. creating tumor specific gene profiles to improve diagnostic accuracy 2. performing gene set validation for diagnostic predictive power 3. defining a discriminate gene list implicated in pathogenesis the tissue procured under this protocol at suny upstate medical university will be limited to excess soft tissue and bone tumor tissue from patients otherwise undergoing clinically indicated procedures for diagnosis or treatment under the care of the local principal investigator (pi) and will be forwarded to the central investigator, r. lor randall, md at huntsman cancer institute for use in the characterization of the gene profiles of these tumors.

as stated in brief summary

Eligibility criteria:
inclusion criteria: * bone or soft tissue tumor that has been established to be or is suspected to possibly be a sarcoma and who will require a diagnostic or therapeutic surgical procedure which will result in procurement of tissue for histologic review exclusion criteria: * non cancer patients

Keywords: create tumor specific gene profiles to improve diagnostic accuracy perform gene set validation for diagnostic predictive power define deviant gene list implicated in pathogenesis
mindfulness practice in pregnancy as an intervention to decrease prenatal stress during the covid-19 pandemic

Conditions: Prenatal Stress

Summary: the purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.


Eligibility criteria:
inclusion criteria: 1. women between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound a. only women with singleton gestations will be included because multiple gestation pregnancies introduce additional levels of stress and introduce confounding variables for the adverse composite pregnancy outcome that will be measured. as this is a study of pregnant patients, only women are included. 2. english speaking a. the mindfulness meditation trainings have been scripted and recorded in english. thus, to understand the recordings and participate in the courses it is necessary for all participants to speak english. 3. regular internet access through either phone, tablet or computer. a. mindfulness meditations are administered via zoom webinars so internet access is required. a proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (emr). exclusion criteria: 1. multiple gestations. this has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events. 2. age \< 18
a cross-sectional study of lipoprotein(a) levels in patients with documented history of atherosclerotic cardiovascular disease (ascvd)

Conditions: Atherosclerotic Cardiovascular Disease

Summary: the purpose of this study is to characterize the distribution of lipoprotein(a) (lp(a)) levels among participants with a history of ascvd as defined by their medical history and is 2-fold: * evaluate the distribution of lp(a) value in the overall participants with documented history of ascvd * evaluate the distribution of lp(a) value in participants with documented history of ascvd by demographics and regions


Eligibility criteria:
inclusion criteria: * signed informed consent * history of ascvd exclusion criteria: * participants known to be currently receiving investigational drug in a clinical study * participants with a diagnosis of end-stage renal disease or requiring dialysis * participants who have received lipoprotein apheresis to reduce lp(a) within 3 months prior to enrollment

Keywords: atherosclerotic cardiovascular disease lipoprotein(a)
psychometric properties of the turkish version of s-rom-neck

Conditions: Neck Pain

Summary: patient-reported joint motion assessment tools have been developed and applied successfully in several joints of the body. "the self administered neck mobility assessment tool (s-rom-neck)" questionnaire was developed by langenfeld et al in 2018. with this questionnaire, the clinicians are able to evaluate the neck joint motion perception of the patients, subjectively. there is no turkish version of the questionnaire. the aim of our study is to develop the turkish version of the s-rom-neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.

neck pain leads to a decreased range of motion in the cervical spine, bringing along functional losses. as a result, this situation is associated with many disabilities. evaluation of neck joint motion is essential in patients with chronic neck pain. it is used to evaluate the neck pain level and functional deficit level of the patient. in this way, it is possible to evaluate the effectiveness of the treatment applied to the patient during the rehabilitation process. generally, this evaluation can be made and interpreted by an experienced clinician. however, patient perception provides a better understanding of patients' needs and problems by converting clinical data into a patient-centered measure. moreover, the patient's perspective can add valuable information to the examination by creating a holistic picture of the patient's problems, possible needs, and expectations. in 2018, the "self administered neck mobility assessment tool (s-rom-neck)" survey was developed by langenfeld et al. with this questionnaire, developers purposed to evaluate the neck joint motion perception of the patients, subjectively. there is no turkish version of the questionnaire. the aim of our study is to develop the turkish version of the s-rom-neck questionnaire, to analyze its cultural adaptation, and to reveal its validity and reliability.

Eligibility criteria:
inclusion criteria: * to have neck pain for at least 3 months. * turkish literate individual exclusion criteria: * operation history due to neck pain problems * individuals diagnosed with tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome * pregnancy * individuals who do not give consent

Keywords: surveys and questionnaires neck pain range of motion psychometrics
determining patterns in trial experiences of parkinson's disease patients

Conditions: Parkinson Disease

Summary: historically, participation in clinical studies is highly skewed towards particular demographic groups of people. this study will invite several participants to gather a wide range of information on clinical trial experiences for parkinson's disease patients. the aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of parkinson's disease. the data collected from this study will help improve future outcomes for all parkinson's disease patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patient plans to participate in an interventional clinical trial for the condition of parkinson's disease * patient has been diagnosed with a type of parkinson's disease * patient is at least 50 to 80 years of age * patient has access to a home internet connection in order to provide regular updates through the course of the study exclusion criteria: * patient has an ecog score of 4 or higher * patient is not able to provide consistent digital updates as per study requirements * patient does not complete or agree to terms outlined in the informed consent form

Keywords: parkinson's disease parkinson's
gene therapy of beta thalassemia using a self-inactivating lentiviral vector

Conditions: Beta-Thalassemia

Summary: this is a phase i/ii clinical trial of gene transfer for treating beta-thalassemia using a self-inactivating lentiviral vector to functionally correct the defective gene(s). the objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

thalassemia is considered the most common genetic disorder worldwide. beta-thalassemia is caused by mutations in the beta-globin gene which encodes the beta-globin protein, leading to the ineffective erythropoiesis, hemolysis and anemia. currently, the only cure for thalassemia is bone marrow transplantation from a related, compatible donor, which has, however, the significant risk of transplant related mortality, graft versus host disease and limited source. therefore, gene transfer, achieved by transplantation of the patient's own stem cells that have been genetically-modified with the corrected gene, could potentially cure thalassemia. this study will use an experimental gene transfer procedure performed in a laboratory to insert the related gene into the participant's autologous stem cells using a self-inactivating lentiviral vector. the purpose of this study is to evaluate the safety and effectiveness of the gene transfer procedure and to determine the ability of the gene-corrected cells at generating new, healthy blood cells in individuals.

Eligibility criteria:
inclusion criteria: 1. diagnosis of beta thalathemia. 2. age: ≥ 4 years. 3. karnofsky: ≥ 80%. 4. left ventricular ejection fraction (lvef): \> 50%; no obvious heart disease and pulmonary hypertension. 5. pulmonary function is normal; forced expiratory volumein one second (fev1) and vital capacity greater than 60% and dlco \> 50%. 6. serum creatinine ≤ 2 × upper limit of normal range. 7. mri showed no super-iron load in the heart and liver, and no severe cirrhosis. 8. normal coagulation. 9. written, informed consent obtained prior to any study-specific procedures. exclusion criteria: 1. diagnosis of active malignant disease (other than bowen disease or cervical cancer); or has family history of cancer. 2. myelopathy, tumor-related cytogenetic changes or other more severe blood diseases. 3. has alcoholism experience within 6 months prior to enrollment. 4. history of epilepsy. 5. history of bone marrow transplantation. 6. existence of an available hla-identical related donor. 7. pregnant or lactating females. 8. subject infected with hcv (hcv antibody positive), hbv (hbsag positive), hiv (hiv antibody positive), htlv (htlv antibody positive), treponema pallidum antibody positive or tb culture positive. 9. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Keywords: beta thalassemia lentiviral vector gene
lung ultrasound for acute dyspnea in emergency department

Conditions: Dyspnea; Congestive Heart Failure

Summary: dyspnea is a frequent symptom in patients admitted to the emergency department (ed); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. the initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. in the last years, lung ultrasound (us) has emerged as a useful real-time bedside diagnostic tool in the critical patient. the aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung us, performed by emergency physicians at the time of patient first presentation to the ed, in identifying cardiac causes of acute dyspnea.


Eligibility criteria:
inclusion criteria: * patients had to present to the ed with a principal complaint of shortness of breath, deﬁned as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours; * presence of an emergency physician with lung us experience at the time of enrollment; * us examination within 30 minutes after the start of the clinical evaluation. exclusion criteria: * dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.

Keywords: ultrasonography
new horizons for the treatment of cardiomyopathy in children

Conditions: Cardiomyopathy

Summary: collecting mono nuclear cells from the patient's blood after a course of granulocyte stimulation then injecting them into the weak heart muscle measuring the heart function at the beginning and after 2.4.6 months to assess the improvement due to this procedure, by comparing these patients to patients with the same condition treated the classic way.

dilated cardiomyopathy in children has high morbidity and mortality, current treatment doesn't improve the prognosis and the only cure available is heart transplantation which is limited, has long waiting list (if available), high cost, and has many side effects, leading to the need of novel effective, less costly therapeutic alternatives. stem cell therapy has proven to improve the cardiac function, reverse the pathologic histological changes, decrease the morbidity and mortality, offering a possible replacement to heart transplantation, different reports proved the safety and efficacy of this therapy using different types of cells and different routs of application in cardiomyopathy and acute myocardial infarction in children and adults, and in congenital heart disease, but the published cases of this therapy conducted on children with dilated cardiomyopathy are scanty .

Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy diagnosed and treated at least 6 mo. ago * lvef less than 40% * use of i.v inotropes exclusion criteria: * acute infection * severe organ failure (other than the heart)

Keywords: dilated cardio-myopathy pediatric mono nuclear cells