Kornimate/medical-research-clean huggingface dataset:
breast cancer detection in breast surgical specimens with the histolog scanner, slide-free confocal microscope

Conditions: Breast Cancer

Summary: study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the histolog scanner, a recent large field-of-view confocal laser scanning medical imaging device.

breast cancer is the commonest cancer in female worldwide and breast-conserving surgery (bcs) became the most frequently performed surgical treatment for women with early-stage breast cancer. the ability to identify subclinical and deep-seated tumor during bcs is still difficult, and the surgeon must rely on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. although there is no consensus on negative surgical margins, at least 20 % of patients undergo more than one procedure to achieve acceptable margins as part of breast-conserving strategy. the development of reliable intraoperative assessment tools which can provide a timely indication of whether re-excision in tumor bed after bcs is indicated at the time of primary surgery would be an asset. the histolog scanner is a recent confocal microscope designed for fresh tissue ex-vivo medical imaging with high resolution and speed to guide intraoperative assessment and offer support in clinical decision making. allowing the quickest and most effective intraoperative assessment of breast surgical specimen regardless of center clinical workflow and intraoperative availability of pathologist, is the aim of this international study. the main objective is to demonstrate that both pathologists and surgeons are able to detect breast cancer tissues in histolog scanner images of breast surgical specimens. fresh breast surgical specimens with breast cancer (invasive or in-situ) will be imaged with the histolog scanner prior standard-of-care final assessment in pathology. content of the images will be reviewed by a board of expert pathologists using the gold standard (h\&e-stained images) as reference. blind assessment of the breast cancer content of these histolog scanner images will be realized by breast surgeons and pathologist.

Eligibility criteria:
inclusion criteria: * adult female patient ≥18 years old * women with diagnosed, operable invasive or in situ ductal carcinoma, invasive lobular carcinoma who are deemed breast surgery candidates (i.e. lumpectomy or mastectomy). * patient able to read, understand and give informed consent exclusion criteria: * patient not informed * patient previously treated for breast carcinoma * patient has undergone presurgical neo-adjuvant treatment * patient is pregnant/lactating * patient is male * participation in any other clinical study that would affect data acquisition

Keywords: breast cancer confocal microscopy fresh tissue imaging intraoperative assessment breast conserving surgery
hypopressive abdominal exercise in postpartum abdominal diastasis

Conditions: Abdominal Diastasis

Summary: the prevalence of abdominal diastasis is high in postpartum. the abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis. hypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. however, there is a lack of studies that determine its effectiveness and clinical utility. the aim of the study will be to analyze the effects of hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature. a case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.


Eligibility criteria:
inclusion criteria: * primiparous or multiparous * abdominal diastasis previously diagnosed * commitment to perform, at least, 80% of the exercises * signed informed consent exclusion criteria: * bmi \> 40 kg/m2 * pelvic floor disorders before childbirth * drugs with effects on continence or functional properties of the pelvic floor muscles * treatment for abdominal diastasis in the last 6 months * systemic disease that impairs pelvic floor physiology and urination * menopause * contraindications to the practice of physical exercise and physical therapy

Keywords: postpartum hypopressive abdominal exercises pelvic floor muscles
a technology-based intervention to support older adults in living independently

Conditions: Older People; Frailty

Summary: the general objective of this study is to test the usability and efficiency of the save prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible.

the save system aims to offer technology-based support to older adults for staying in their familiar surroundings for as long as possible, while feeling safe and optimally cared for. the save technology has been designed and developed according to the approach of the user centered design (ucd), which involves multiple interactions with users to under-stand their needs and preferences and to involve them in the design process for creating a truly useful and appreciated technological product. secondarily, it supports informal caregivers, like relatives, in providing optimal care for their loved ones, while maintaining their professional and private life. the general objective of this study is to test the usability and efficiency of the save prototype for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible. the study involves the use of the save platform for a total of 21 consecutive days.the study involves the use of a mixed-methods approach, in which both qualitative (open questions) and quantitative (standardized tests) data will be collected, and three different measurements (t0, t1, t2) will be made during the period of use of the system. the data collection card will therefore be divided into two different sections, which correspond to the three different moments of detection: 1) at time 0, that is, before the start of the experi-mentation (t0); 2) at time 1, after 10 days, i.e. at the midterm of the trial (t1), and 3) at time 2, after 21 days, i.e., at the end of the trial (t2). the log data of the usage of the save sys-tem be the primary, secondary, and tertiary users will be continuously stored over the 21 days test period.

Eligibility criteria:
inclusion criteria: * mini mental state evaluation (mmse) between 21 and 24 * healthy or mild to moderate chronic illness or musculoskeletal disease * feel physically fit to participate in the study exclusion criteria: * participants suffer from severe chronic disease

Keywords: technology-based intervention older adults active ageing
talocalcaneal angle in calcaneal spur formation

Conditions: Foot Callus; Plantar Fascitis

Summary: calcaneal spur is one of the most common causes of chronic heel lower face pain without a traumatic cause. obesity, sedentary life and advanced age play a role in its etiology. mechanical overload is the main factor in the development of the disease. impaired biomechanical factors in the foot cause repetitive microtraumas, traction periostitis and degenerative changes in the plantar fascia. the calcaneal spur is a result of this pathological process that creates pain. many static radiological evaluation methods are used to evaluate the effect of foot anatomy in etiology. the talocalcaneal angle is one of them. it is the angle between the long axis of the talus and the long axis of the calcaneus. this angle shows the alignment of the back of the foot. it decreases with varus angulation of the back of the foot and increases with valgus angulation. in this study, it was aimed to determine the place of the talocalcaneal angle values measured in the lateral radiographs of the foot in the etiology of painful calcaneal spur formation.

the study was designed retrospectively. in this study, talocalcaneal angles of patients with heel pain and epin on lateral foot radiograph will be compared with talocalcaneal angle measurements on lateral foot radiographs without epin calcanei. measurements will be made by the same physician, 3 measurements will be made and the average value will be recorded. it was aimed to investigate the effect of talocalcaneal angle on calcaneal spur formation.

Eligibility criteria:
inclusion criteria: patients between the ages of 30-75 who applied to our outpatient clinic with the complaint of pain with pressing on the heel for at least 3 months. • patients with calcaneal spur detected in the lateral radiographs of the feet exclusion criteria: those who complain of heel pain for less than 3 months, have any rheumatological disease, have a previous history of foot and ankle fractures

Keywords: heel pain talocalcaneal angle calcaneal spur
safety and efficacy clinical study of severe hemophilia b treatment with kl001

Conditions: Hemophilia B Without Inhibitor

Summary: this is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of kl001 injection solution in hemophilia b subjects with ≤2 iu/dl residual fix levels.

this is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of kl001 injection solution in hemophilia b subjects with ≤2 iu/dl residual fix levels. nine subjects will be enrolled and administered with three different doses of kl001. subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of kl001. all subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of kl001 for total 5 years.

Eligibility criteria:
inclusion criteria: 1. male ≥12 years of age. 2. moderate/severe or severe hemophilia b (baseline fix activity ≤2% of normal or documented history of fix activity ≤2%). 3. at least 3 bleeding episodes per year that require on-demand treatment with fix or are treated with a prophylactic regimen of fix. 4. at least 100 days exposure history to recombinant or plasma-derived fix protein products. 5. no neutralizing antibodies to exogenous fix protein products. 6. willing and able to comply with study procedures and requirements. exclusion criteria: 1. suffering from chronic inflammatory muscle disease. 2. positive in hepatitis b or hepatitis c. 3. infection with hiv-1 or hiv-2 and cd4+t cell count ≤ 200/ μ l. 4. history of thrombosis or susceptibility to thrombosis. 5. current or previous participation in another gene therapy study. 6. has any other significant medical condition that the investigator feels would be a risk to the subject or would impede the study.
zeit alert for stroke at home (zash) protocol

Conditions: Acute Ischemic Stroke; Ischemic Stroke; Stroke

Summary: this is a single-arm, observational, feasibility study to evaluate if the halo alert system can be used in the future to detect stroke events in individuals at risk for stroke wearing the halo alert system overnight.

this is a single-arm, observational, feasibility study to evaluate if the halo alert system can be used in the future to detect stroke events in individuals at risk for stroke wearing the halo alert system overnight. the halo alert system consists of an eeg sensor headband and is paired with a data transfer device. approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. the eeg tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. the labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.

Eligibility criteria:
inclusion criteria: 1. new ischemic stroke confirmed by neuroimaging (ct or mri scans) as the reason for current hospital admission or stroke clinics visit. time from ictus to enrollment should be ≤ 2 weeks; 2. rre-90 \> 2; 3. age ≥ 18 years old; 4. patient is discharged to home; 5. provision of signed and dated informed consent form. exclusion criteria: 1. subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population; 2. treatment with another investigational drug or intervention within the last two (2) weeks prior to start of this study, if said drug/intervention is expected to interfere with the normal function of the halo alert system; 3. does not have wifi internet access in their home; 4. does not have access to a smartphone; 5. open traumatic injury on the head; 6. allergy to any of the components of the headband, such as the fabric of the band (88% rayon, 9% nylon, 3% spandex), the electrode surfaces (conductive silver ink.)

Keywords: reoccurring detection
supplemental oxygen reduces surgical infection

Conditions: Wound Infection

Summary: supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. we tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. colorectal surgery patients (n=300) were randomly assigned to 30% or 80% fio2 intraoperatively and 6 hours postoperatively. wound infections were diagnosed by blinded investigators using centers for disease control criteria. baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. wound infection rates were compared with chi-square analysis. logistic regression identified the contribution of potential confounding factors. surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (p\<0.039). according to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (p=0.035). supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. we thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.

context: supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection. objective: we tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. design: randomized, controlled trial. setting: fourteen spanish hospitals. patients: three hundred patients undergoing elective colorectal surgery. interventions: patients were randomly assigned to either 30% or 80% fio2 intraoperatively and for 6 hours after surgery. anesthetic management and antibiotic administration were standardized. main outcome measures: wound infections were diagnosed by blinded investigators using centers for disease control criteria. baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. the wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. a logistic regression was used to identify the contribution of potential confounding factors.

Eligibility criteria:
inclusion criteria: * elective colorectal resection, * patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery. exclusion criteria: * exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type i or ii), hiv infection, weight loss exceeding 20% in the previous three months, serum albumin concentration \< 30 g/l, and a leukocyte count \<2500 cells/ml.

Keywords: oxygen surgical complications colo-rectal resections
prospective evaluation of confirmatory testing for primary aldosteronism

Conditions: Primary Aldosteronism

Summary: this study is to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose acth stimulation test for the diagnosis of primary aldosteronism.

this is a prospective study (with a target recruitment of 200 participants) designed to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose acth stimulation test for the diagnosis of primary aldosteronism, using disease-specific treatment response as a reference gold standard. subjects consenting to study participation will undergo a standardized seated saline infusion test, followed by an ultra low-dose acth stimulation test. all participants also receive adrenal vein sampling. individuals who have unilateral disease and desire surgery will receive adrenalectomy (as part of routine care) and the remaining subjects will receive medical treatment with a mineralocorticoid receptor antagonist. response to targeted treatment will be considered the reference gold standard for the establishing the diagnosis of primary aldosteronism.

Eligibility criteria:
inclusion criteria: * individuals with hypertension * individuals with an elevated screening adrenal renin ration (arr) * individuals with high probability features of primary aldosteronism (e.g., resistant hypertension, spontaneous or diuretic-induced hypokalemia, and/or an adrenal nodule) with clinical indications for adrenal vein sampling and surgery (if appropriate). exclusion criteria: * individuals with chronic kidney disease (estimated glomerular filtration rate \<40 ml/min/1.73m2), * individuals with a history of heart failure, chronic edema, uncontrolled severe hypertension (systolic blood pressure \>180 and/or diastolic blood pressure \>110 mmhg), untreated hypokalemia, cortisol-secreting adrenal adenoma, and/or pheochromocytoma * individual who previously received confirmatory testing.
the effect of music on maternal stress and milk amount

Conditions: Amount of Breast Milk; Maternal Anxiety Level

Summary: premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. it is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. this stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; it causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. in order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. music improves endothelial function by dilating the vessels; it has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. this study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.


Eligibility criteria:
inclusion criteria: * mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies, * whose babies are not connected to mechanical ventilation, * who are over 18 years of age, who are not diagnosed with any psychological disease and * who agree to participate in the study will be included in the study. exclusion criteria: * greater than 32-37 weeks of gestation
safety and efficacy of eribullin or eribulin combined with anlotinib in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: eribulin is the promising agent for late-line metastatic breast cancer patients. the aim of this phase ii, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of eribullin or eribulin combined with anlotinib in patients with metastatic breast cancer

the aim of the double-arm, open-label, phase ii clinical trial is to assess efficacy and safety of eribulin or eribulin combined with anlotinib in metastatic breast cancers. the investigator hypothesize that both eribulin and eribulin combined with anlotinib may be an effective alternative treatment for metastatic breast cancers. in addition, eribulin combined with anlotinib might be able to improve the treatment response and progression-free survival.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, voluntary consent and signed written informed consent * ecog 0\~2 * pathologically diagnosed her2-negative breast cancer patients with radiologically confirmed locally advanced (stage iiib or iiic) or metastatic (stage iv) breast cancer; hr-positive patients were permitted * at least one measurable disease lesion before treatment * never receive eribulin mesylate treatment or anti-angiogenetic therapies before recruitment * anticipated survival time is longer than three months * brain metastases with stable disease or without clinical symptom * blood routine test, liver and kidney function test meet the following criteria: plt \> 100g / l, hb \> 9g / l, neutrophil \> 2.0 g/l; ast and alt \< 2.5 upper limit of normal (uln); cr \< 1.0 uln; tbil \< 1.5uln * previously treated with anthracycline-based and taxane-based chemotherapy regimens (at least one line of chemotherapy in the metastatic setting or the recurrence time is less than 1 year from the end of adjuvant or neoadjuvant chemotherapy); for hr-positive/her2-negative patients, progressed after at least one line of endocrine therapy * for women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment; men agreed to take appropriate contraceptive measures during the study treatment and at least half a year after the end of the treatment. exclusion criteria: * pregnant or lactating women * active infection requiring systemic treatment * hiv positive * suffering from or suspected of suffering from central neuromuscular system diseases * serious heart disease; uncontrollable hypertension; history of heavy hemorrhea；recent operation within three months * the investigator considered that the patient was not suitable for in this study, with any other situation.