Kornimate/medical-research-clean huggingface dataset:
impact of radiation therapy on breast conservation in dcis

Conditions: DCIS

Summary: large regional variation exists in the use of radiotherapy after breast-conserving surgery (bcs) for ductal carcinoma in situ (dcis). although patients who do not receive initial radiotherapy for dcis are candidates for subsequent bcs if they experience a second breast event, many undergo mastectomy instead.

patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient. although the incidence of dcis has risen dramatically (1), there exists considerable debate about optimal treatment. in general, people with dcis have high rates of recurrence-free survival. intensive therapies for dcis such as mastectomy (removal of the breast) or radiation therapy following bcs reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) in addition, radiation usually necessitates mastectomy should a new cancer or dcis develop in the same breast at any point during the patient's lifetime. patients also have a small chance of experiencing long-term toxicity. previous radiation can also complicate reconstructive options following mastectomy. the tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making. patients who receive bcs alone without radiation therapy may be candidates for repeat bcs if they have a second breast event in the same breast. one study suggests that some women choose not to have radiation after dcis because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) however, the likelihood of mastectomy versus bcs at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of dcis. we sought to study whether regional intensity of radiation use for dcis treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial dcis diagnosis. (punglia rs, cronin am, uno h, et al. association of regional intensity of ductal carcinoma in situ treatment with likelihood of breast preservation. jama oncol. published online july 21, 2016.)

Eligibility criteria:
this study used data from seer and seer-medicare.

Keywords: dcis pcori ductal carcinoma in situ radiation oncology patient-centered decision aid decision-making
treatment of post-partum depression using an behavioral intervention called rose (reach out, stay strong, essentials for mothers of newborns) delivered using an electronic app

Conditions: Post-partum Depression

Summary: a randomized trial of pregnant people at risk for postpartum depression comparing the inbloom app (n = 76) to rose (n = 76; weekly scheduled group), and two control groups. we will assess depression at baseline and 1, 2 and 3 months, roi at 3 months, satisfaction at 1 and 3 months and perceived access at 1 and 3 months. subject participation will last up to 8 months (minimum 17 weeks pregnant through 3 months postpartum).


Eligibility criteria:
inclusion criteria: * 17-32 weeks pregnant * enrolled for prenatal care in one of the five identified practices * english speaking * able to use an app (audio/visual/dexterity) * have one or more of the following ppd risk factors: medicaid eligible; anxiety (gad-7 \> 10) during pregnancy; mild to moderate depressive symptoms (phq-9 = 10-19); self-reported history of depression treatment; gestational diabetes; and/or young age (18-21 years). exclusion criteria: * patients with acute mental health needs * cannot communicate in english * demonstrate significant cognitive impairment * are planning to place the child for adoption * phq-9 depression score \> 19 * younger than age 18
to share or not to share

Conditions: History of Suicide Attempt

Summary: the purpose of the study is to evaluate the group-based intervention "to share or not to share" in a german clinical setting. feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.

people who have survived a suicide attempt often face public and self-stigma, and secrecy is a common strategy to minimize the risk of being labeled. both secrecy and disclosure have pros and cons. the decision whether, when, and to whom to disclose a previous suicide attempt is complex. interventions can provide guidance for systematic consideration and a well informed decision. potentially, it may not be disclosure itself, but the empowered decision for or against disclosure of a previous suicide attempt that reduces distress and leads to beneficial outcomes. the manualized peer-led group intervention "honest, open, proud" (hop) supports people with mental illness in their decision whether to disclose mental illness. research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. based on hop, "to share or not to share" (2share) was developed to systematically guide suicide attempt survivors through their decision whether and how to disclose a previous suicide attempt. 2share led to significant reductions in self-stigma and depressive symptoms, as well as increased self-esteem in a recent pilot randomized-controlled trial (rct) in the us. the aim of the current study is to evaluate 2share in a german clinical setting. feasibility and efficacy of 2 share will be tested in a pilot rct.

Eligibility criteria:
inclusion criteria: * current inpatient, outpatient or day clinical treatment at the bezirkskrankenhaus günzburg, germany * age ≥ 18 years * at least one previous suicide attempt * positive screening for disclosure distress (1 item: "in general, how distressed or worried are you in terms of secrecy or disclosure of your suicide attempt?", self-report, persons with a score ≥ 4 on a scale from 1-7 are included) * written informed consent * sufficient german language skills exclusion criteria: * current suicidality (1 item: "have you had thoughts that you would be better off dead for at least several days during the last week?", self-report, persons responding with yes will be excluded and will be offered support) * suicide attempt within the last four weeks * dementia or organic disease (icd-10: f0) * primary substance dependence (icd-10: f1x.2)

Keywords: stigma suicide attempt survivor secrecy group intervention disclosure
characteristics of culprit lesion and changes in plaque composition. a dual energy cardiac ct study

Conditions: Coronary Arteriosclerosis

Summary: identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology. in this study the investigators will investigate culprit lesion in patients with nstemi and the ability of cardiac ct with dual energy computed tomography (dect) scanning to describe and identify plaques that may be vulnerable. the investigators will also describe changes in characteristic in both stable and unstable plaques during 1 year follow up of nstemi and a matching group of stable angina pectoris (sap) patients.

patients with verified nstemi undergo contrast-enhanced coronary dect before conventional coronary angiography (cag), and dect characteristics of the culprit lesion will be determined. all non-culprit lesions will be observed during 2 month and 1 year follow up characteristics and changes in plaque composition, volume and core content will be assessed. patients with sap undergo a baseline dect similar to nstemi group. because the expected change in coronary plaques in sap group is minimal, there is no need for follow up at 2 month.

Eligibility criteria:
inclusion criteria: * patients with nstemi and scheduled to cag or patients with sap exclusion criteria: * not suitable to undergo ct with contrast agent: * known allergy-like reactions to contrast or claustrophobia * atrial fibrillation or significant arrhythmia judged to potentially limit quality of ct * known renal failure/insufficiency or s-creatinin\> 140 µmol/l. * severe/symptomatic thyrotoxicosis * pacemaker

Keywords: culprit lesion arteriosclerosis cardiac ct
computerized tomography (ct) scan study of bone healing following open wedge proximal tibial osteotomy

Conditions: Osteoarthritis; Varus Malalignment

Summary: the purpose of this study is to assess whether there is a difference between the tomofix and ellipse intramedullary hto nail system in terms of bone regeneration in the tibial wedge by performing a ct-scan at 3 and 6-months postoperatively.

malalignment of the knee joint causes arthritis in later life. currently there are three surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and high tibial osteotomy (hto). the former two very much focus on treating the effect of malalignment, i.e. removing the arthritic joint. however, hto addresses the cause of the arthritis, namely the joint malalignment. this preserves the patient's joint and it means that a patient will start using the unaffected part of the knee joint more. hto involves cutting a wedge out the tibia to correct the alignment of that bone with the knee joint, to redistribute load from the affected medial part to lateral part. to keep the tibia in the new position, a medical nail device is attached to keep it in place and allow new bone to regenerate within the wedge. currently, the market leader for hto is the tomofix (by depuysynthes company) plate and nail device. as the name suggests, tomofix is fixed at surgery and therefore the change in bone angle cannot be changed afterwards. it does mean that patients can be weight-bearing on the affected leg soon after the hto procedure. a new ce-marked device is being tested in an interventional trial; it is produced by ellipse technologies. this device is an extendable nail and inserted intramedullary; following surgery the nail is tend slowly extended over a period of time until the bone correction is satisfactory. the cisko imaging study will assess whether there is a difference between the tomofix and ellipse system in terms of bone regeneration in the tibial wedge by performing a ct-scan at 3 and 6 months post-operatively. this will be quantified by two independent radiological reports. a secondary objective is to investigate patient satisfaction and also patient pain levels at these time intervals. the degree of bone healing is usually the main factor holding clinicians back when it comes to advising patients on what activities they can return to post-operatively. a difference in bone healing between the two systems may impact on the advice clinicians can give patients regarding recommencing more intense activities such as recreational sports, which ultimately could positively impact patients' health and well-being.

Eligibility criteria:
inclusion criteria: 1. indicated treatment with medial open wedge proximal tibial osteotomy, either with tomofix device or ellipse device 2. provision of written informed consent 3. males 4. mental capacity exclusion criteria: 1. under age (\< 18 years) 2. patients lacking mental capacity. 3. females 4. current use of nicotine products. 5. patients who cannot understand english and therefore cannot be consented.
realize the current situation of copd patients in china

Conditions: Chronic Obstructive Pulmonary Disease COPD

Summary: this is a multi-centre, prospective, observational study to realize the current situation of copd patients in china. about 5000 copd patients will be enrolled from 50 participating sites around china and followed up for one year. during this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.

this is a multi-centre, prospective, observational study. this study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of copd in china.this is an observational study. it will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. information about exposure to treatments as part of routine care will be collected (dose, frequency and duration). a multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around china as the study sites. approximately 5000 patients with copd will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.

Eligibility criteria:
inclusion criteria: * outpatients, more than 40 years old * clinically diagnosed as copd (the patients are clinically diagnosed as copd based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(fev1/fvc\<0.7, post-bronchodilator according to gold 2016) * sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study. exclusion criteria: * participated in any interventional clinical trial during the last 30 days * with acute exacerbation within 4 weeks before enrolment * not suitable for study observation judged by investigators.

Keywords: copd
effectiveness of an ehr interface to reduce dosage of hydroxychloroquine

Conditions: Rheumatic Diseases

Summary: hydroxychloroquine (hcq) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. although generally well tolerated, study data have demonstrated that long-term use of hcq may lead to irreversible and potentially vision-threatening retinal toxicity. the american academy of ophthalmology (aao) issued guidelines in 2011, and again in 2016 that recommended dosing of hcq be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. while clinicians have been aware of the potential side effects of hcq for decades, studies have shown that many patients continue to receive higher than recommended doses. the goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (erx) interface for prescriptions of hydroxychloroquine (hcq). the investigators will measure the effectiveness of the system in reducing the number of individuals prescribed hcq over current guidelines by randomizing clinicians to the new interface. ideally, the erx interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of hcq.


Eligibility criteria:
inclusion criteria: * all providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics exclusion criteria: * inactive providers in rheumatology and dermatology clinics
the validate-d study

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study is to evaluate whether vitamin d receptor agonist therapy lowers renin-angiotensin system activity.

this study aims to evaluate whether vitamin d receptor agonist therapy (calcitriol) in diabetes lowers renin-angiotensin system (ras) activity in a manner similar to an ace inhibitor. this is a physiology study, focused on evaluating hormonal changes in the circulating and tissue ras when compared to placebo. subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation of their circulating and renal-vascular ras activity and urinary protein at baseline, after withdrawing interfering medications, while on a controlled electrolyte diet, and in controlled posture settings. they will then randomly receive a study medication (calcitriol or placebo) for 3 weeks followed by a re-assessment of their ras parameters. the main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating renin activity (primary), as well as measures of the renal-vascular ras (renal plasma flow) and urine protein (secondary) the primary outcome is the change in the plasma renin activity when sodium restricted, before and after intervention. secondary outcomes include the change in renal plasma flow and urine protein when sodium loaded, before and after intervention.

Eligibility criteria:
inclusion criteria: 1. type-two diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily) 2. normal blood pressure, or mild (stage 1) hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug. 3. age \>18 years and \<70 years 4. estimated gfr \> 60ml/min 5. normal laboratory values for: complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis 6. electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia. exclusion criteria: 1. chronic kidney disease or egfr\<60 2. history of nephrolithiasis (kidney stones) 3. multiple (more than one) insulin injections daily (since insulin can alter the ras) 4. poorly controlled type 2 diabetes (that may require more aggressive therapy) as defined by an hba1c\>8.5% 5. type 1 diabetes 6. stage 2 or stage 3 hypertension or the use of more than 1 antihypertensive drug 7. chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of nsaids by a physician. 8. the use of prescribed doses of potassium supplements. 9. history of liver failure 10. history of parathyroid or granulomatous disorders 11. history of heart failure, cerebrovascular disease or coronary heart disease 12. history of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy) 13. illness requiring overnight hospitalization in the past 6 months 14. active tobacco or recreational drug use 15. pregnancy or current breast feeding
irreversible electroporation ablation combined with anti-pd(l)1 therapy for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: pancreatic cancer is a highly lethal malignant tumor of the digestive tract, especially local advanced pancreatic cancer (lapc), which often loses the opportunity for surgical resection at the time of diagnosis. lapc patients are often accompanied by tumor invasion of key anatomical structures such as major blood vessels, and traditional treatment methods such as radiotherapy and chemotherapy can slow down the progression of the disease, but the effect is limited, and the overall survival rate is still very low. there is a lack of effective treatment options for lapc, especially in local control and prolonging survival, which exists a major limitation. the surgical resection rate is low in lapc, and the postoperative recurrence rate is high, and traditional radiotherapy and chemotherapy are difficult to completely eliminate the tumor. immunotherapy has achieved breakthroughs in other tumors such as melanoma and non-small cell lung cancer, but the effect is limited in pancreatic cancer due to the immunosuppressive state of the tumor microenvironment (tme), which limits the efficacy of immunotherapy. in addition, the high invasiveness and rapid progression of pancreatic cancer further aggravates the treatment challenge. recent studies have shown that local ablation techniques such as irreversible electroporation (ire) ablation not only can effectively ablate local tumors, but also may destroy the structural integrity of tumor cells, release tumor-associated antigens, and enhance the anti-tumor effect of the immune system. therefore, ire ablation may provide local control of pancreatic cancer for patients. at the same time, the combination of immune checkpoint inhibitors such as anti-pd(l)1 inhibitors may enhance the immune response in the tumor microenvironment and further improve the therapeutic effect. this combined treatment regimen is expected to overcome the limitations of single therapy and provide a new treatment strategy for local advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * the pathological diagnosis is local advanced pancreatic cancer that cannot be removed by surgery; * received ire ablation treatment alone or in combination with anti-pd-1 or anti-pd-l1 immune inhibitors; * aged 18 years or older, gender is not limited, ecog score 0-2; * have complete medical records and imaging follow-up records; * at least 6 months of follow-up data. exclusion criteria: * patients with other malignant tumors or severe immune system disorders; * patients who cannot complete follow-up or have missing data; * patients who have previously received immunotherapy without effect; * patients with severe organ dysfunction or who cannot tolerate further - - treatment.

Keywords: pancreatic cancer irreversible electroporation pd-(l)1
study of high-dose chemotherapy (hdc) combined with adoptive cellular therapy with dc-cik cells in triple negative breast cancer patients

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: to access the effectiveness of high-dose cyclophosphamide combined chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

1. metastatic breast cancer patients should be definitively diagnosis based on histopathology, with er-negative and pr-negative, fish testing for her-2-negative 2. all the patients enrolled will be given standard hdc and cellular therapy.hdc and cellular therapy consisting of one cycle of hdc followed by an apheresis and ex vivo cultures to generate dc and cik. dc-cik infusions were given to each patient, followed by two cycles hdc, plus low-dose oral cyclophosphamide. 3. pet-ct scans were done on each patients at baseline and after chemotherapy. the response is assessed using response evaluation criteria in solid tumor group (recist) guidelines. 4. estimate time to progression, survival rates and clinical benefit response on patients. 5. find biomarkers associated with drug response.

Eligibility criteria:
inclusion criteria: * failure to anthracycline and/or taxol chemotherapy; * metastatic tumor is histologically confirmed by immunohistochemical staining to be er-negative and pr-negative. fish testing for her-2-negative; * metastatic tumor can not be removed through surgery procedure; * metastatic tumor measured by pet-ct scan is at least 1cm; * an eastern cooperative oncology group (ecog) performance status of 0-2; * normal cardiac, hepatic, renal and bone marrow functions; * life expectancy ≥3 months. exclusion criteria: * do not finish twice pet-ct scan; * central nervous system metastases; * serious or uncontrolled concurrent medical illness; * history of other malignancies; * having been enrolled in some other clinal trials within a month;

Keywords: breast neoplasm neoplasm metastasis drug therapy