Kornimate/medical-research-clean huggingface dataset:
post market registry for the omnipod 5 system in children and adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the omnipod 5 system in children and adults with type 1 diabetes.

this is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the omnipod 5 system in children and adults with type 1 diabetes. a minimum of 2,200 type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. the minimum number of completed participants is as follows: * 150 participants aged 2-5 * 300 participants aged 6-13 * 300 participants aged 14-17 * 900 participants aged 18+ in addition to the enrollment targets above, a minimum of 1100 omnipod-naïve users, 880 pump-naïve users, and 110 cgm-naïve users will be recruited. participants are expected to be followed for 12 months.

Eligibility criteria:
inclusion criteria: 1. self-reported type 1 diabetes 2. prescribed, obtained, and have been using the omnipod 5 system for no more than two weeks or plan to start using the system within the next two weeks 3. willing to use only the following types of u-100 insulin during the study: humalog u-100, novolog, or admelog 4. able to read and speak english or spanish (when available) fluently and reside full time in the united states 5. willing to collect a1c samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months 6. willing and able to complete registry assessments every two weeks 7. willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal) 8. is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control 9. access to internet via phone, tablet and/or computer to use the registry online platform 10. willing to provide cgm and insulin delivery data collected prior to using the omnipod 5 system, if available (participants will not be excluded if data is not provided) 11. willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable exclusion criteria: 1. diagnosed with sickle cell anemia and/or hemoglobinopathy 2. planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on omnipod 5 3. adults that are unable to provide informed consent

Keywords: type 1 diabetes omnipod automated insulin delivery registry
sex differences, cognitive training & emotion processing

Conditions: Alcohol Use Disorder

Summary: this pilot project addresses two understudied questions related to neurocognitive deficits observed in treatment-seeking alcoholics. first, whether cognitive training improves performance and outcomes in alcoholics, and whether men and women differ in their response to this training. the second is whether directed training using affective materials (e.g., emotional faces) is differentially effective compared to that using traditional (i.e., neutral) stimuli.

this pilot project leverages the team's expertise in neurobehavioral assessment and focus on sex differences to examine the potential efficacy of cognitive training in treatment-seeking men and women with alcohol use disorders (auds). specifically, the ask whether cognitive training interventions derived from current methods and conceptual models has differential benefits for treatment-seeking women vs. men. although neurocognitive improvement during training is desired, of practical import is whether gains achieved transfer to other tasks and settings. therefore, transfer of gains to tasks/domains varying in their similarity to training are assessed. given noted sex differences in emotional processing and the purported role of emotional factors in women's substance use, training engaging emotional processing via the use of affective stimuli (faces and words) is included, predicting that women may differentially benefit from such training. equal numbers of treatment-seeking men and women with auds will be randomly assigned to one of two active training interventions (neutral or affective stimuli). to control for abstinence-related recovery, a third group of participants, meeting identical selection criteria, will complete pre and post-intervention testing, but will not undergo the training intervention. ss will complete baseline, 3 wks training (for active groups) and post-intervention testing and will be contacted monthly for 3 months after discharge.

Eligibility criteria:
inclusion criteria: * minimum of 10 years of education * subjects must have 20/40 or better corrected vision (determined by snellen chart) * have no significant hearing impairment as determined by self-report and audiometric testing * must meet criteria for dsm-iv alcohol dependence using the computerized diagnostic interview schedule - iv * a craving index is also administered to allow discussion in terms of dsm 5 classification. * comorbid substance use including nicotine use is not exclusionary. exclusion criteria: * may not have medical or psychiatric histories which would confound participation or data interpretation, e.g., epilepsy, stroke, untreated hypertension, psychotic disorders, anxiolytic medications. * not be color blind (as determined by psuedoisochromatic plates) * endorsement of suicidal intent

Keywords: cognitive training emotion processing
cellular and tissue based therapy registry

Conditions: Diabetic Foot Ulcers; Venous Stasis Ulcer; Pressure Ulcer; Chronic Non Healing Wound; Surgical Wound Dehiscence

Summary: the goal of the cellular and tissue based therapy registry (ctpr) for wounds is to provide real world patient data from electronic health records submitted to meet stage 2 meaningful use in order to understand the value of these products among patients with chronic wounds and ulcers. randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these rcts tend to be non-generalizable. little is known about the effectiveness of ctps among typical patients.

the goal of the cellular and tissue based therapy registry (ctpr) for wounds is to provide comparative effectiveness data for patients with chronic wounds and ulcers and to understand whether clinical practice guidelines are followed in the use of these products. these products are referred to by a variety of names of which are inaccurate reflections of their structure or purpose (e.g. cellular and engineered tissue alternatives, "bioengineered tissues," "biological dressings"). the preferred term is cellular and/or tissue based products (ctps). ctps are utilized for their biological influence on the healing process by stimulating or supporting healing. they may or may not be incorporated into regenerating tissue. both tissue derived and biosynthetic products may be made with or without dead cells and biomaterials made of living cells may be comprised of autologous cells (cultured and not cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).the diversity of products and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. effectiveness in real world patients is the best current option to understand the role of ctps in wound healing. hospital based outpatient wound centers participating in the us wound registry agree to provide data as part of quality initiatives and to meet their stage 2 meaningful use criteria. the ctpr is a subset of the uswr data. all patient data from all participating outpatient clinics are transmitted to the uswr where it is available for benchmarking, pqrs and other initiatives. data used for effectiveness research is hipaa de-identified. these data are derived from structured language entries directly transmitted from electronic health records which also link to billing and charge documents once practitioners sign and lock charts, confirming the veracity of data entries.

Eligibility criteria:
inclusion criteria: * patients receiving cellular and tissue based products exclusion criteria: * none

Keywords: electronic health records qualified clinical data registry pqrs quality reporting cellular based products bioengieered skin uswr
supplemental anterior lumbar interbody fusion (alif) in spinal deformity

Conditions: Spinal Deformity

Summary: within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. this is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region. the hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.


Eligibility criteria:
inclusion criteria: * 18 years or more of age * planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium exclusion criteria: * malignancy * infection

Keywords: spine deformity instrumentation alif
using a fan with aromatherapy in breathlessness patients in terminal illness

Conditions: Breathlessness; Aromatherapy; Fans; Terminal Illness

Summary: difficulty breathing is a very devastating symptom, often seen in terminal patients. accompanied by physical, psychological, emotional, and social limitations, not to mention the ambiguity in the occurrence of dyspnea symptoms and the difficulty in obtaining satisfactory quality of symptom care. the purpose of this study is to confirm the use of non-drug interventions in clinical situations, such as fans and aromatherapy to alleviate the complications of end-stage patients. the effectiveness of the symptoms of dyspnea.

difficulty breathing is a very devastating symptom, often seen in terminal patients. accompanied by physical, psychological, emotional, and social limitations, not to mention the ambiguity in the occurrence of dyspnea symptoms and the difficulty in obtaining satisfactory quality of symptom care. the purpose of this study is to confirm the use of non-drug interventions in clinical situations, such as fans and aromatherapy to alleviate the complications of end-stage patients. the effectiveness of the symptoms of dyspnea. inclusion criteria 1. over 20 years old. 2. it is determined by the physician to meet the final diagnosis conditions. 3. symptoms of dyspnea. 4. the daily physical status of patients is assessed using the east coast cancer clinical research cooperative organization assessment scale (eastern cooperative oncology group, ecog) ≧ 2 points. 5. able to communicate in mandarin or taiwanese or written conversation. 6. unconscious disorder. 7. after explaining and explaining, agree to participate in this research and sign the consent form. exclusion criteria 1. receive treatment for facial trigeminal nerve damage. 2. abnormal sense of smell.

Eligibility criteria:
inclusion criteria: 1. over 20 years old. 2. it is determined by the physician to meet the final diagnosis conditions. 3. symptoms of dyspnea. 4. the status of patients is assessed using the east coast cancer clinical research cooperative organization assessment scale (ecog) ≧ 2 points. 5. able to communicate in mandarin or taiwanese or written conversation. 6. conscience clear. 7. after explaining and explaining, agree to participate in this research and sign the consent form. exclusion criteria: 1. receive treatment for facial trigeminal nerve damage. 2. abnormal sense of smell.
passport to freedom (p2f): adaptation and implementation of a wellness program

Conditions: Trauma

Summary: women currently residing at an emergency shelter for women and children will participate in group sessions that cover topics that promote physical and emotional well-being through a combination of mindfulness exercises and health promotion activities..

in a group setting, the intervention will cover topics such as mindfulness, health (examine impact of trauma and stress on physical and mental well-being), healthy relationships, family matters (coping with conflicts) and reflection session. each group session (5) will last approximately 90 minutes, once weekly, and begin and end with mindfulness exercises. the women are also encouraged to download free mindfulness apps to practice the exercises between sessions. women enrolled will receive health information that will cover a range of chronic health topics (pain, asthma, hypertension, diabetes, obesity), to complement already existing tools on mental health and post traumatic syndrome. women enrolled will complete surveys: baseline questionnaires, a pre and post survey during each session, and follow-up questionnaires 4 weeks after the intervention.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to read and write english * currently residing at the house of ruth maryland emergency shelter or onsite transitional housing. exclusion criteria: * under 18 years of age * inability to speak or write english * physical or mental health conditions that would prevent meaningful group participation.

Keywords: trauma stress depression coping mindfulness
a research study for patients with overactive bladder

Conditions: Overactive Bladder; Urinary Incontinence

Summary: the purpose of this study is to investigate whether injections of botulinum toxin type a into the bladder are safe and effective in treating overactive bladder.


Eligibility criteria:
inclusion criteria: * must be between 18-85 years old * must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago * must weigh at least 50 kg (110 lbs) * must be willing and able to record information regarding bladder function into a diary (provided) * must be willing and able to complete the entire course of the study exclusion criteria: * cannot currently be catheterizing as a way to control incontinence * must not have used botulinum toxin type a or any other botulinum toxin previously for any condition
characterization of dyslipidemia in adolescent obesity

Conditions: Obesity

Summary: the primary objective of this pilot study is to characterize the profile of lipoprotein, inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as compared to normal-weight age-matched controls.


Eligibility criteria:
inclusion criteria: * age 13-19 * bmi ≥25 (obese) or \<25 (normal weight) exclusion criteria: * prior diagnosis of any eating disorder (e.g. anorexia or bulimia) * prior diagnosis of any congenital lipid disorder (e.g. familial hypercholesterolemia) * current use (or within past 6 months) of any lipid altering medications
metabolic syndrome diagnosis and education trial

Conditions: Metabolic Cardiovascular Syndrome

Summary: this study is being done to gain knowledge on how effective different approaches of providing a diagnosis and varying educational tools that include dvds and multimedia or printed instruction sheets on your readiness to increase the subject's level of exercise, lose more weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart disease and their readiness to participate in a comprehensive lifestyle modification program.


Eligibility criteria:
inclusion criteria: any 3 of the following 5: 1. history of hypertension or either systolic blood pressure \>125 or diastolic blood pressure \>85 mmhg or documented history and receiving treatment for it 2. abdominal circumference ≥40 inches in men or ≥35 inches in women 3. fasting triglycerides ≥ 150mg/dl or receiving treatment for it 4. fasting blood glucose ≥ 100mg/dl but \<126mg/dl 5. hdl cholesterol \<40mg/dl in men or \<50mg/dl in women or receiving treatment for it exclusion criteria: 1. documented diagnosis of metabolic syndrome in the clinical record, if previously seen at mayo. 2. history of coronary artery disease 3. diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance 4. congestive heart failure 5. familial hypercholesterolemia including familial hypertriglyceridemia, 6. fasting ldl-cholesterol \>160 mg/dl 7. fasting triglycerides \> 390 mg/dl 8. have systolic blood pressure \>160 and diastolic blood pressure \>100mg/dl 9. history of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment. 10. history of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment. 11. secondary causes of obesity such as hypothyroidism, cushing syndrome, or eating disorders 12. pregnant women or women planning to get pregnant during the duration of the study 13. advanced liver disease 14. renal insufficiency 15. having any other major chronic medical condition 16. unable to do their basic chores at home due to musculoskeletal limitations or other factors affecting their functional status. 17. physical activity of more than 60 minutes per week of moderate to intense exercise

Keywords: metabolic cardiovascular syndrome
β blocker use and mortality in hospital survivors of acute myocardial infarction without heart failure

Conditions: Acute Myocardial Infarction

Summary: the aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction patients only * aged 18 to 100 years exclusion criteria: * other final diagnosis besides acute myocardial infarction * died in-hospital * patients with missing mortality data * aged \> 100 * patients with previous acute myocardial infarction or angina * patients who have received coronary interventions before * patients with heart failure * patients with β blocker prior use * patients contraindicated for β blocker use * patients with use of a loop diuretic

Keywords: acute myocardial infarction mortality evidence-based care myocardial ischaemia national audit project β blockers
epigenetic biomarker for osteosarcoma

Conditions: Histologic Response (Tumor Necrosis Rate); Objective Response Rate for Neoadjuvant Chemotherapy, ORR; Progression-free Survival, PFS; Overall Survival, OS

Summary: hme-seal is a low-input whole-genome cell-free 5hmc sequencing method based on selective chemical labeling. it uses β-glucosyltransferase (βgt) to selectively label 5hmc with a biotin via an azide-modified glucose for pull-down of 5hmc-containing dna fragments for sequencing. after selectively constructing 5hmc library, highthroughput-sequencing will be performed on an illumina nextseq-500 instrument. by ways of rawdata processing, differential loci between osteosarcoma group and control group will be detected to indentify specific epigenetic biomarkers of osteosarcoma.

the investigator want to enroll 100 osteosarcoma participants initially treated in musculoskeletal tumor center of peking university people's hospital(pkuph). all those participants will follow the chemo-protocol for osteosarcoma in pkuph.8 ml of peripheral blood would be drawed before each cycle of chemotherapy for further analysis. after definitive surgery, participants will need to take 8ml of peripheral blood every 2 months for 6 months. a total of 6 times of blood drawing will need to be done. in hme-seal approach, peripheral blood is collected into edta-coated vacutainers. plasma is collected from the blood samples after centrifugation at 1 600× g for 10 min at 4 °c and 16 000× g at 10 min at 4 °c. cfdna is extracted using the circulating nucleic acid kit(qiagen). after that, cfdna (1-10 ng) is end repaired, 3'-adenylated and ligated to dna barcodes using kapa hyper prep kit (kapa biosystems). ligated dna is incubated in a solution containing hepes buffer, udp-6-n3-glc and βgt . after that, dbco-peg4-biotin is directly added to the reaction mixture. next, dna is purified by micro bio-spin 30 column (bio-rad). the purified dna is incubated with m270 streptavidin beads (life technologies) in specific buffer. the beads are subsequently undergone three 5-min washes each with four kinds of different buffers. all binding and washing are done at room temperature with gentle rotation. beads are then resuspended in water and amplified with 16 cycles of pcr amplification. the pcr products are purified using ampure xp beads. pair-end 38bp sequencing is performed on the nextseq-500 instrument.

Eligibility criteria:
inclusion criteria: * 1) histologically confirmed high-grade osteosarcoma; * 2) older than 10 yrs; * 3) initially treated in musculoskeletal tumor center of peking university people's hospital; * 4) serum samples are available; * 5) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy; * 6) expected to live longer than 3 months with eastern cooperative oncology group performance status of 0 or 1; * 7) acceptable hematologic, hepatic, and renal function. exclusion criteria: * 1) serum samples are not qualified; * 2) patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy; * 3) lost to follow-up.

Keywords: osteosarcoma epigenetic biomarker hme-seal technique