Kornimate/medical-research-clean huggingface dataset:
furosemide for accelerated recovery of blood pressure postpartum

Conditions: Hypertension, Pregnancy-Induced

Summary: a randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy

hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. while significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (pphtn) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. few studies have investigated the incidence and proper management of hypertension in the postpartum period. furthermore, in the united kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (hdp) in the postpartum period. postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. these studies clearly show that pphtn is associated with significant morbidity and that it is important to develop interventions that can reduce its effects. in patients with hdp, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. this phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.

Eligibility criteria:
inclusion criteria: * hypertensive disorder of pregnancy diagnosed antepartum or intrapartum * gestational hypertension * pre-eclampsia with or without severe features * superimposed pre-eclampsia with or without severe features * new diagnosis of hdp within 24 hours from delivery * postpartum, delivery ≥ 20 weeks estimated gestational age * age ≥18 years old exclusion criteria: * history of allergic reaction to furosemide * high risk comorbidities for which treatment may be indicated or contraindicated: class c or higher diabetes mellitus, chronic kidney disease or baseline creatinine \>1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease * baseline labs with k \<3 * use of furosemide or other diuretics antepartum or intrapartum * use of ototoxic agents including aminoglycosides (ie, gentamicin for \>1 dose), cephalosporins (ie ancef \>1 dose), * patient unstable for protocol per investigator's judgement

Keywords: furosemide postpartum hypertension
muscle dysfunction in patients with haematological diseases

Conditions: Hematologic Diseases; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Myelodysplastic Syndromes; Lymphoma

Summary: purpose: to evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. it is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Eligibility criteria:
inclusion criteria: • patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the department of haematology, rigshospitalet. exclusion criteria: * age: \<18 * pregnancy * physical or mental disabilities precluding test of muscle function * inability to read and understand danish.

Keywords: hematological cancer diseases muscle mass muscle strength complications patient reported outcomes physical function
systematic screening for comorbid psychological conditions in cardiac acsc patients with multimorbidity in the ed

Conditions: Depression; Anxiety; Somatoform Disorders; Alcohol Abuse

Summary: emaspot assesses the prevalence and impact of mental health conditions in multimorbid emergency patients with cardiac acsc on transsectoral utilisation of health care services.

the specific aims of emaspot are primarily to determine the prevalence of mental health conditions (mhc) (i.e., symptoms of depression, anxiety, somatoform disorders, and alcohol abuse) in patients with multimorbidity and cardiac acsc in a prospective cohort study. the study population comprises patients admitted to an ed in berlin-mitte during the study period from 01.06.2017 to 31.05.2018 with cardiac complaints who are admitted to the hospital or discharged from ed. the study focusses especially on older and multimorbid patients. multimorbidity is defined as the presence of more than two chronic diagnoses. after having given informed consent patients are enrolled in the study and interviewed by a study nurse. self-reported symptom burden for depression, anxiety disorders, somatoform disorders, alcohol abuse as well as frequency of utilization of health care services are assessed. medical data will be abstracted from medical charts and include somatic comorbidities, medication and diagnostic procedures and interventions during hospitalization. individual semi-structured interviews will be conducted with 30 patients to assess the treatment expectations and underlying motives for ed-visits, as well as with 30 health care professionals to investigate perceptions of challenges regarding identification and treatment of patients with mhc. all patients will have a 6-months follow-up after discharge from the ed. the follow-up is conducted either by telephone calls, e-mail or via mail. the follow-up data will include mental health conditions as assessed at baseline, frequency of utilization of health care services and health-related quality of life.

Eligibility criteria:
inclusion criteria: * patients presenting to one of the eds in berlin-mitte due to cardiac complaints (acute heart failure, angina pectoris, dyspnea, arrhythmias) * age 50 and older exclusion criteria: * age 49 and younger * inability to give written informed consent (cognitive impairment, legal guardianship) * insufficient language skills to complete the questionnaire in one of the provided languages (german, english, russian, turkish)

Keywords: mental health conditions in acsc patients multimorbidity health care utilization
efficacy of kyphoplasty with a new intervertebral expander

Conditions: Vertebral Body Compression

Summary: balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. however, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. an intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. this study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.


Eligibility criteria:
inclusion criteria: * osteoporotic vertebral body fractures that were classified as a1 fractures according to arbeitsgemeinschaft osteosynthesis (ao) classification exclusion criteria: * more than 2 vertebral body fractures * fractures of vertebral body based on malignancy * previous spinal operation * spinal infection * spinal deformity (scoliosis)

Keywords: vertebral fracture kyphotic deformity kyphoplasty vertebroplasty
toronto gestational glucose tolerance cohort

Conditions: Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

Summary: in this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.

in this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (gdm) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. this cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (t2dm) and cardiovascular disease. at regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. the longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of t2dm and cardiovascular disease.

Eligibility criteria:
inclusion criteria: * pregnant women exclusion criteria: * pre-existing diabetes before the index pregnancy
holistic needs assessments in patients with melanoma

Conditions: Melanoma; Unsatisfied Needs

Summary: this study will assess whether a needs assessment/management intervention for patients with malignant melanoma is achievable, reasonable, realistic and of value to patients with malignant melanoma and health professionals involved in their care. the study will also explore what the levels of patients' unmet needs are, whether unmet needs change over time, and what the potential effects of the intervention may be on patients' unmet needs, symptom severity, self-confidence in dealing with the illness, wellbeing, and satisfaction with the care received. in this study, the investigators will involve skin cancer nurse specialists, who will be asked to use an 'intervention questionnaire' to offer a needs assessment/management intervention to 30 people newly diagnosed with malignant melanoma. the investigators have used information from the literature to select the most appropriate 'intervention questionnaire' for this patient population. each consenting patient (i.e. participant) will be expected to participate in the study over 4 months. during the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. at the start of each intervention consultation, participants will be asked to complete the intervention questionnaire. the recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs. throughout the study, participants will also be asked to complete a set of questionnaires in the clinic (months 1 and 3) or at home (months 2 and 4) to explore potential effects of the intervention. a study evaluation form will be used at month 4 to collect participants' and health professionals' views on the intervention and how it was delivered. face-to-face interviews will take place at the end of the study to explore participants' (a subset of 10 people) and health professionals' experiences with the intervention.

no additional detail, study has ended

Eligibility criteria:
inclusion criteria: * a diagnosis of malignant melanoma stage i or ii regardless of tumour thickness. * within 1 month post-initial diagnosis following a mdt meeting. * aged 18 years or over. * deemed by a member of the mdt to be physically and psychologically fit to participate. * able to read and write english. * able to provide written informed consent. exclusion criteria: * patients not meeting the afore-mentioned criteria will be excluded.

Keywords: supportive care unsatisfied needs melanoma holistic assessment patient-reported outcomes proms
a study of the safety profile of first-line avastin (bevacizumab) in combination with paclitaxel in patients with locally recurrent or metastatic her2-negative breast cancer (avatax)

Conditions: Breast Cancer

Summary: this single arm, open label study will assess the safety profile of avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic her2-negative breast cancer. patients will receive avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * locally recurrent or metastatic her2-negative breast cancer * locally recurrent disease must not be amenable to radiation therapy or resection with curative intent * eastern cooperative oncology group (ecog) performance status 0-2 * prior adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of \>/=12 months is required * adequate haematological, renal and liver function exclusion criteria: * previous chemotherapy for locally recurrent or metastatic disease * radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of \</= 30% of marrow-bearing bone) * cns metastases * pre-existing peripheral neuropathy * clinically significant cardiovascular disease
assessment of pain and antibacterial activity of chitosan versus sodium hypochlorite as irrigant in infected canal

Conditions: Postoperative Pain

Summary: a randomized clinical trial that aims to study the effect of chitosan nanoparticles (cs-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against e.faecalis in infected root canal.

this trial aims to study the effect of chitosan nanoparticles (cs-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against e.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.these will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. in group i: sodium hypochlorite (naocl 2.5%) will be used during instrumentation of the canals.in group ii: chitosan nanoparticles (cs-np) will be used. after preparation, the sample no.2 will be taken.pain will be assessed by giving the patient the numerical pain rating scale (nrs) to assess his pain at 24, 48 and 72 hours after the first visit.

Eligibility criteria:
inclusion criteria: * young adult patients, both genders, aging from 18-45 years. * patients with permanent mature teeth (closed apex). * single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium. * patients should be free from any systemic disease. * patients with normal periodontal depth less or equal 3 mm. * patients who will agree to the consent and will commit to follow-up. exclusion criteria: * patients with permanent immature teeth. * teeth with vital pulps. * patients with facial swelling or acute infection or pain on percussion * patients with fistula. * teeth with vertical root fractures, internal or external root resorption and calcification * teeth with periodontal involvement or periapical bone loss. * patients with any systemic disease that may affect predictable outcome. * pregnant or lactating females. * non-restorable teeth.
observational study to evaluate the safety and efficacy of polyclonal antibodies in simultaneous pancreas kidney transplant recipients

Conditions: CKD (Chronic Kidney Disease) Stage 5T; Diabetes Mellitus; Simultaneous Pancreas Kidney Transplantation

Summary: a single-centre, prospective, observational study to evaluate the safety and efficacy of polyclonal antibodies in simultaneous pancreas kidney transplant recipients.

polyclonal antibody mainly contains antit-tlymphocyte globulins(grafalon) and anti-thymocyte globulins(atg). to investigate the efficacy and safety of polyclonal antibodies induction regimen using grafalon compared with atg in de novo simultaneous pancreas kidney transplant recipients. the primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate. the secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, dgf(delayed graft function), pancreas function and renal function

Eligibility criteria:
inclusion criteria: 1. with end-stage,diabetic nephropathy(type1or 2) 2. patients scheduled to undergo spk with compatible abo blood type. 3. peak pra \<50% 4. females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study. 5. patient must have signed the patient informed consent form. 6. patient must receive a primary simultaneous pancreas/kidney (spk) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages. exclusion criteria: 1. patient is pregnant or breastfeeding. 2. patient has a positive t-cell crossmatch on the most recent serum specimen. 3. patient is known for active liver disease or has significant liver disease, defined by asat and alat serum levels greater than 3 times the upper limit of normal. 4. patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence. 5. patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation. 6. patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication. 7. patient receives a spk transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone. 8. donor is older than 55 years of age 9. patients with bacterial, viral or mycotic infections which are not under therapeutically control

Keywords: grafalon atg spk
bcma-car-t in relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Myeloma

Summary: evaluation of the safety and efficacy of bcma nanobody car-t cells in relapsed/refractory myeloma

there are no effective regimens for relapsed/refractory myeloma. bcma express extensively in mature b cells and plasma cells. myeloma cells express bcma universally. bcma signal pathway can induce plasma cell proliferation and survival, down-regulation of bcma could control the progression of myeloma. the bcma car used in this study consists of bcma nanobody, cd8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Eligibility criteria:
inclusion criteria: * 18 and ≤70 years old and the expected lifetime \>3 months * active myeloma according to imwg criteria, and bcma positive by immunohistochemistry or flow cytometry * no effective treatment option available * ecog score 0-2 * sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function nyha grade 1-2; liver: tbil ≤ 3uln, ast ≤ 2.5uln, alt ≤ 2.5uln; kidney: cr≤ 1.25uln); * smoothly peripheral superficial veins * no other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation) * no history of other malignancies * women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study * the patient himself agrees to participate in this clinical study and signed the "informed consent" exclusion criteria: * severe infectious 4 weeks before enrollment * active hepatitis b or c viral hepatitis, hiv, * severe autoimmune disease or immunodeficiency disease * severe allergies * severe mental disorder * patients who used high-dose glucocorticoids within 1 week * participation in other clinical studies in the past 3 months or having been treated with other gene products
evaluation of envisio smartclip for intraoperative localization of breast masses

Conditions: Breast Cancer

Summary: this is a pilot study to estimate the success of the smartclip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.


Eligibility criteria:
inclusion criteria: * participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the smartclip localization system at the mckinley operative suites at moffitt cancer center. multiple sites for localization may be used, up to a maximum of 3 smartclips per patient. mammographically or sonographically visible biopsy clips may be used as a localizing target. * participants must be age \> or = 18 years. exclusion criteria: * participants with sonographically or mammographically occult target lesions * participants with greater than 35cm chest to bust depth * participants undergoing mastectomy for resection of the targeted lesion * inability to undergo surgery at the mckinley or suites due to institutional anesthesia guidelines * patients requiring use of more than 3 smartclips to localize targets

Keywords: smartclip envisio™ navigation system
a study to describe patterns of care and outcomes of men who are at high risk after experiencing biochemical failure following definitive prostate cancer therapy, men with castration-resistant prostate cancer and men with metastatic prostate cancer

Conditions: Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Prostate Cancer

Summary: the purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

each subject will be followed from the time of enrollment for a minimum of 3 years and a maximum of up to 6 years or until death, whichever comes first.

Eligibility criteria:
inclusion criteria: * diagnosis of prostate adenocarcinoma * will receive a new intervention at the time of study entry, for the treatment of: * biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a psa doubling time of one year or less or a confirmed psa of ≥ 50 ng/ml (2 consecutive values) within 6 months prior to study entry; or * castration-resistant prostate cancer; or * metastatic prostate cancer at initial diagnosis of prostate cancer exclusion criteria: * prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy * life expectancy of \<1 year due to comorbidities

Keywords: metastatic prostate cancer castration-resistant prostate cancer prostate cancer