Kornimate/medical-research-clean huggingface dataset:
study to evaluate efficacy and safety of s303 treated red blood cells (rbcs)in subjects with thalassemia major requiring chronic rbc transfusion

Conditions: Thalassemia Major

Summary: to evaluate the efficacy and safety of s 303 treated red blood cells (rbcs) in subjects who require chronic transfusion support due to thalassemia major.

to evaluate the efficacy and safety of s 303 treated red blood cells (rbcs) in subjects who require chronic transfusion support due to thalassemia major.

Eligibility criteria:
inclusion criteria: * age ≥10 years, of either gender * diagnosed with thalassemia major and currently participating in a chronic transfusion program * at least a one year history of chronic rbc transfusion support with a stable transfusion requirement (per treating physician) * intervals of at least 14 days between rbc transfusions * all rbc components are given on one day for each transfusion episode * negative direct antiglobulin tests (dat) * stable iron chelation regimen * available for measurement of hemoglobin level at one hour post transfusion * signed and dated informed consent form exclusion criteria: * baseline antibody specific to s 303 treated rbc (positive test, as defined in section 8.4.1) * evidence of splenic hyper function defined as a transfusion requirement \>180 cc/kg/year (at 100% hematocrit) * splenic enlargement: spleen palpable ≥4 cm below costal margin or ≥18 cm in longitudinal diameter by ultrasound (chosen at the investigator's discretion according to the data available with ultrasound data being preferable) * any subject for whom a transition in the number of rbc units transfused is anticipated within 12 months of study entry due to growth of the subject (e.g. a transition from 1 rbc component per transfusion cycle to 2 or a transition from 2 to 3 is anticipated based on weight change alone) * alloimmunization to high frequency blood group antigens to the extent that the ready provision of compatible blood may not be feasible for the study (alloimmunization alone is not an automatic exclusion) * current specialized treatment with washed or frozen rbc * requirement for gamma irradiated rbc components (would present blinding difficulty due to blood component labeling regulations * treatment with any medication that is known to adversely affect rbc viability * hiv infection (defined as rna positive) * hcv (hepatitis c)infection (defined as rna positive) if treated with concomitant medications known to suppress the bone marrow * pregnant or breast feeding female, or female of child bearing potential not using a medically approved form of contraception * acute or chronic medical disorder other than thalassemia that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study * participation in another clinical study, either concurrently or within the previous 28 days, in which the study drug or device may influence red blood cell viability

Keywords: s303 treated rbcs
tumor immune mechanism of axillary lymph node metastasis in early luminal type a breast cancer

Conditions: Immune Microenvironment; Luminal A; Lymph Node Metastases

Summary: luminal type a breast cancer is a type with good clinical prognosis, and the proportion of lymph node metastasis is low, but a small number of patients have more lymph node metastasis when the primary tumor is very small, and the survival is poor, suggesting that this part of luminal a breast cancer has the different expression of some genes from that of general luminal a breast cancer, which affects tumor invasion and participates in the occurrence of tumor metastasis. but the mechanism is not clear, especially in the current tumor microenvironment and immune related mechanisms.we want to investigated the relationship of the transcriptional tumor immune microenvironment with early lymph node metastasis among luminal a type breast cancer.


Eligibility criteria:
inclusion criteria: * invasive breast cancer with luminal a type;t1 with positive lymph node or t2/t3 with negative lymph node exclusion criteria: * missing specimen
lean diabetes study

Conditions: Lean Diabetes Mellitus

Summary: systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with lean diabetes (ldm) as compared to a control population with obese type 2 diabetes (odm).

background: the prevalence of lean (bmi \<25, non-type 1) diabetes (ldm) is not rare; however, the reason why these individuals develop diabetes without traditional risk factors is often not investigated. since this subset of individuals with diabetes are not overweight, they represent an ideal population to examine the causes of diabetes development without the confounding effect of obesity. understanding critical risk factors for non-autoimmune causes of beta cell underdevelopment, injury and failure can impact prevention, early detection and even treatment in this population of lean individuals. guidelines for diabetes management currently mainly targets either type 1 or overweight/obese type 2 diabetes (odm) with a lack of guidance on how best to personalize work-up and treatment in ldm. objective: systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with ldm as compared to a control population with odm. understanding why certain lean individuals develop diabetes will potentially elucidate mechanisms that could be masked when obesity is also present. study hypothesis: ldm patients have more impaired beta cell function than classic odm. the potential pathogenic drivers for the beta-cell impairment in ldm may involve in-utero/childhood malnutrition, lifestyle insults to beta-cells like alcohol and smoking and specific genetic traits that impair beta cell function.

Eligibility criteria:
inclusion criteria: cases: bmi \ 29 with diabetes, not having exclusion criteria exclusion criteria: individuals \ 10%
sleep, insulin sensitivity, and weight in adolescents post-bariatric surgery

Conditions: Sleep

Summary: assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.


Eligibility criteria:
inclusion criteria: * ages 12-21 years * attending high school or middle school (peak period for insufficient and delayed sleep) * completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation * all must also be tanner stage 5 exclusion criteria: * regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications) * hba1c ≥6.5% * intelligence quotient (iq) \<70 or severe mental illness
assessing the effectiveness of self- and clinician-administered crisis response planning for suicide risk

Conditions: Suicide, Attempted; Suicidal Ideation

Summary: the aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the crisis response plan (crp) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military veterans experiencing current death or suicidal ideation.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * us military veteran * death or suicidal ideation/suicide attempt within the past month exclusion criteria: * non-veteran status * acute intoxication or active psychosis precluding provision of informed consent * inability to communicate and comprehend english * residence outside the united states * lack of past-month death/suicide ideation or attempt * lack of device connected to webcam or internet
remote ischemic conditioning for motor recovery after acute ischemic stroke

Conditions: Ischemic Stroke

Summary: the most recent treatment for stroke rehabilitation is to combine physical training with other therapies to enhance or accelerate recovery.the hypothesis of this study is that remote ischemic conditioning (ric) might have a beneficial effect on motor recovery of ais

despite the effective reperfusion therapies ,acute ischemic stroke(ais) is still one of the leading causes of disability, resulting in an economic burden. multidisciplinary rehabilitation has benefit effects on motor recovery and remains the first-line intervention strategy for attenuating motor function impairments. however, the effect of the physiotherapy application alone is not satisfactory, the potential treatment effect of ric on motor recovery of ais has not been investigated. the investigators designed this randomized clinical trial to examine whether ric has a beneficial effect on poststroke motor function recovery.there are 2 arms in this trial: one arm is ric treatment, the other one is sham ric treatment. the motor function will be assessed by fugl-meyer motor scale before and after the treatment to evaluate its exact effect on motor recovery.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18-80 years; 2. first-ever unilateral ischemic stroke,5\~10 days after onset; 3. had motor dysfunction caused by stroke(fugl-meyer≤55) 4. mrs≤1 before stroke 5. nihss 6\~20 6. written consent was obtained from the subject. exclusion criteria: 1. cannot complete assessments-ie, psychiatric disorders, sensory aphasia, dementia 2. brainstem lesion or cerebellun lesion 3. poorly controlled diabetes mellitus 4. application of agent which thought to impair or improve recovery based on laboratory and clinical evidence within 1 month (ie,da,maoi, ssri,α1/α2 adrenergic receptor inhibitors,bzd,etc) 5. severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Keywords: remote ischemic conditioning
expanded access for the treatment of cancers with rearranged during transfection (ret) activation

Conditions: Non Small Cell Lung Cancer; Medullary Thyroid Cancer; Colon Cancer; Breast Cancer; Pancreatic Cancer; Papillary Thyroid Cancer; Other Solid Tumors With Evidence of Activating RET Alteration

Summary: expanded access for participants with cancer with ret activation who are ineligible for an ongoing selpercatinib (also known as loxo-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. the treating physician/investigator contacts lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

n/a for expanded access

Eligibility criteria:
inclusion criteria: * diagnosis of cancer with ret activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib * have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy * have adequate organ function exclusion criteria: * currently enrolled in an ongoing clinical study of selpercatinib or another ret inhibitor * clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the qt interval corrected for heart rate using fridericia's formula (qtcf) interval greater than 470 milliseconds
effects of telehealth initiative on lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: sle is mostly seen in young women and causes significant deformity in patients. in sle, disease activity, body damage due to disease or treatment, comorbidities, and drugs affect body image negatively. sle causes changes in the body such as skin rashes, uneven pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks, weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of independence, which worsens the subjective well-being of patients. can affect in that direction. subjective well-being (sbl) is the scientific term for happiness, and sle is thought to have a significant negative impact on swb.

telehealth has been proposed as a component of patient education for disease management. telehealth, which is defined as the remote delivery of health services via telecommunication tools including telephone and internet, enables accessible and appropriate health care service and provides communication, support, and monitoring opportunities with patients. researchers think that a telehealth education initiative can be effective on the pain and life activities of sle patients and this effect will improve their happiness in a good way. based on these findings, this study aimed to examine the effects of a specific telephone educational intervention on pain, happiness, and activities of living in patients with sle. the hypothesis of this study is; is that adapted telehealth education intervention can increase the happiness and life activities of patients with sle and reduce pain.

Eligibility criteria:
inclusion criteria: * those between the ages of 18-45, * diagnosed with sle disease * those who are in remission of the disease * those who do not use biological dmards * non-smokers * those who do not drink alcohol * those with low disease activity score, * neurological, psychiatric disease and non-malignant, * individuals who are literate, able to communicate verbally and agree to participate in the study, among those evaluated and approved by their physicians. exclusion criteria: * having a chronic disease other than sle * having a rheumatological disease other than sle * having a disability to use the phone * those with hearing loss or visual impairment, * those who have undergone changes in the treatment process and those who practice non-drug therapy during the study will not be included in the study. in determining the inclusion, exclusion and termination criteria, both the literature and the consultation of a specialist in the field were taken.

Keywords: life activities pain happiness
singing in groups for parkinson's disease; a pilot study of group singing therapy for pd-related voice/speech impairment

Conditions: Voice Quality and Voice Loudness Associated With Parkinson's Disease

Summary: this study will compare group singing to group speech therapy without singing. you may be eligible for this study if you have been diagnosed with pd for one year or more and you have a quiet voice or difficulty being understood.

the national parkinson foundation center of excellence at beth israel deaconess medical center is conducting a research study to test whether group singing therapy helps people with voice or speech disorders due to parkinson's disease (pd). communication problems, including loss of vocal loudness, affect many people with pd. while existing forms of speech therapy have been shown to be helpful, group singing may be a beneficial alternative to traditional speech therapy. the study will involve participating in weekly treatment sessions where subjects will receive training in vocal exercises from a speech-language pathologist with expertise in pd, as well as instructions for structured home practice. participants will be assigned to a singing or non-singing group for the 12-week treatment phase of the study. researchers will measure subjects' vocal function and communication-related quality of life before and several times after the 12-week program. all subjects and their care partners are welcome to participate in a singing group following the study. you may be eligible for this study if you have been diagnosed with pd for one year or more, and you have difficulty with your voice or speech such as quiet voice, or difficulty being understood.

Eligibility criteria:
inclusion criteria: * difficulty being heard or understood * diagnosis of parkinson's disease for one year exclusion criteria: * no other neurological conditions(i.e. stroke, cerebellar ataxia) that affect voice quality * no history of vocal chord hemorrhage

Keywords: parkinson's disease, voice quality, vocal strength, voice loudness
participant database for autism research studies

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

aim 1: to recruit people interested in research on autism and other neurodevelopmental disabilities aim 2: to complete a diagnostic assessment, to confirm the diagnosis of autism spectrum disorder or other developmental disability (e.g., developmental language delay) in our patient population and rule out a diagnosis of autism spectrum disorder and other comorbid conditions in our control group aim 3: to maintain subject information in a database, from which we can recruit for our studies

Eligibility criteria:
inclusion criteria: * typically-developing, healthy adolescents and adults (ages 14-32) * adolescents and adults with autism spectrum disorder (ages 14-32) exclusion criteria: * extreme premature birth (\<34 weeks) * known genetic disorders related to autism (e.g. fragile x) * recent diagnosis of psychosis (within 6 months) * some other psychiatric diagnoses may be excluded following screening (e.g. tourette's syndrome). * metal implants / permanent retainers / hair dyes with metallic components

Keywords: autism autistic language development developmental assessment
satisfaction/quality of life with rivaroxaban in spaf (stroke prevention in atrial fibrillation) indication

Conditions: Atrial Fibrillation

Summary: national, multicenter, prospective, observational, non-interventional study. the objective is to determine if the switch from vitamin k antagonists (vka) to xarelto in subjects treated with vka with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. the treatment satisfaction will be measured by the anti clot treatment scale (acts) score.


Eligibility criteria:
inclusion criteria: * female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation * who are treated with vitamin k antagonists (vka) with issues for at least the 4 previous weeks (issues are assessed on medical judgment) * who start treatment with rivaroxaban to prevent stroke or non-cns (central nervous system) systemic embolism * with anticoagulation therapy planned for at least 6 months exclusion criteria: * contra indication to the use of xarelto as described in the summary of product characteristics (smpc); key contra indications are: * hypersensitivity to the active substance or to any of the excipients listed in smpc section 6.1. * lesion or condition at significant risk of major bleeding * concomitant treatment with any other anticoagulant agent * clinically significant active bleeding * hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with child pugh b and c * pregnancy and breast feeding

Keywords: sf36 questionnaire anti clot treatment scale satisfaction quality of life rivaroxaban stroke prevention
pemetrexed and gemcitabine every 14 days versus every 21 days in advanced non small cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: this study is designed to evaluate pemetrexed and gemcitabine day 1 followed by gemcitabine day 8 every 21 days (arm a) and pemetrexed and gemcitabine day 1 every 14 days (arm b) in patients with nsclc. each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic nsclc. therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase ii arena.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of nsclc stage iiib or iv * no prior systemic chemotherapy for advanced non-small cell lung cancer * prior radiotherapy must be completed at least 4 weeks before study enrollment. exclusion criteria: * estimated life expectancy of 12 weeks * a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease * documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment * significant weight loss (that is, \> 10%) over the previous 6 weeks before study entry.
nutrition and coping education for symptom and weight management for fibromyalgia

Conditions: Fibromyalgia; Obesity

Summary: research has shown that weight problems are very common in fibromyalgia. research also suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and biochemical vulnerability associated with fibromyalgia. effective weight management may be important in not only improving general health but also better management of fibromyalgia symptoms. research has indicated that nutrition and coping education is important aspects of successful weight management. in this study, the investigators are evaluating the effect of nutrition and coping education on weight and symptom management of fibromyalgia among overweight and obese patients.


Eligibility criteria:
inclusion criteria: * fibromyalgia patients whose body mass index is greater than 25. * age 21-65 of both sex and all race. exclusion criteria: * co-occurring progressive disease * planning to have surgery in the next year * pregnancy or planning to be pregnant in the next year * having known cardiovascular diseases * having known serious psychopathology (diagnoses of psychosis, organic mental disorder, dissociative disorder, active suicidal intent, inpatient admission to psychiatric ward in the past year, evidence of self-injurious behaviors in the past year, current or recent history (2years) of non-iv substance abuse, any history of recreational iv drug use) * having autoimmune disorder (e.g., rheumatoid arthritis) * having neuropathic pain * having pain associated with terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) * concurrent use of weight controlling medications (eg, xenical) * a history of weight reduction surgery * concurrent participation in weight loss programs or other cognitive-behavioral coping therapy * self-reported physician diagnosed conditions of chronic bronchitis, asthma, or emphysema * report history of head injury, neurological illness, diagnosis of learning disability, learning problems, or special education, substantial toxin or chemical exposure within five years of fms onset, near drowning, recreational iv drug use
epidemiology and clinical presentation of h1n1 infection in children in geneva

Conditions: Healthy; Immunosuppressed; Asthmatic; Neuromuscular Diseases

Summary: this study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in geneva, with influenza a/ h1n1 infection during the current pandemic.


Eligibility criteria:
inclusion criteria: * suspicion of h1n1 infection exclusion criteria: * not available for a 30 days follow-up

Keywords: influenza a h1n1 children epidemiology treatment oseltamivir genetics