Kornimate/medical-research-clean huggingface dataset:
identifying predictors of bipolar disorder relapse during pregnancy and the postpartum period

Conditions: Bipolar Disorder

Summary: this study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.

bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. the onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. the course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. however, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. this study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period. participation in this study will last up to 6 months postpartum. study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. during study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. the study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. additionally, plasma, serum, and urine samples will also be processed and stored at each study visit.

Eligibility criteria:
inclusion criteria: * medically healthy * meets dsm-iv criteria for bipolar disorder of any subtype * no more than 32 weeks gestation, dated by last menstrual period exclusion criteria: * active suicidality or homicidality * acute psychotic symptoms

Keywords: psychiatry pregnancy
linear and non-linear analysis of eeg changes in schizophrenia after atypical antipsychotics medication

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate clinical meaning of eeg changes in antipsychotic-treated patients with schizophrenia.

electroencephalographic (eeg) changes are abundant in patients receiving antipsychotic treatment. however, studies on the meaning of these changes are rare. the results of traditional analyses based on linear methodologies were inconsistent and hard to interpret. therefore, non-linear analyses of eeg may provide additional information in evaluating antipsychotic-induced changes in eeg. in this study, we hypothesized that linear and non-linear eeg changes in patients with schizophrenia may be valuable in predicting treatment outcome. we also hypothesized that the assessment of other psychotic symptoms and side effects of antipsychotics may provide additional information in interpreting the results of eeg analyses.

Eligibility criteria:
inclusion criteria: * male or female patients, 15-65 years of age. * patients must have a diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv). * patients who are drug-naive or drug-free for more than 4 weeks. * patients who are scheduled to receive atypical antipsychotics. * each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation. * subjects who are fluent in korean. exclusion criteria: * dsm-iv substance (except nicotine or caffeine) dependence within the past 1 year. * mental retardation (iq \< 70). * neurological disorders including epilepsy, stroke, or severe head trauma. * clinically significant laboratory abnormalities, on any of the following tests: cbc with differential, electrolytes, bun, creatinine, hepatic transaminases, urinalysis and ekg. * treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline. * history of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months. * subjects who are not fluent in korean.

Keywords: schizophrenia atypical antipsychotics eeg
lipoprotein lipase enzyme activity assay validation and clinical assessment

Conditions: Lipoprotein Lipase Deficiency

Summary: this study plans to learn more about measuring lipoprotein lipase (lpl) activity in humans. lpl is an enzyme in the breakdown of certain types of fats into smaller parts. lipoprotein lipase deficiency (lpld) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. this can cause conditions known as high triglycerides in the blood and inflammation of the pancreas. investigational medications to treat lpld are currently being developed. in order to see if these medications are effective, it is necessary to be able to accurately measure lpl activity in humans. lpl activity has been successfully measured in animal models after giving heparin. heparin is a blood thinner which is approved by the fda. it is originally used to prevent blood clots. this study will administer heparin to healthy adults through intravenous infusion (iv). blood samples will be collected before and after the infusion to test ldl levels. the purpose of this study is to develop a cheap, more reliable standard for assessment of lpld in patients


Eligibility criteria:
inclusion criteria: 1. male and females between ages of 20-39 exclusion criteria: 1. past history of lpl deficiency 2. hypercholesterolemia (cholesterol \>200, ldl \>160, hdl \ 150), any familial lipid disorder 3. diabetes mellitus (type 1 or 2) 4. uncontrolled hypertension sbp\>140, dbp\>90 5. history of hemorrhagic stroke 6. current pregnancy 7. history of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study 8. exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening 9. history of allergy to heparin 10. history of heparin-induced thrombocytopenia 11. current smoking 12. active ulcerative or angiodysplastic gi diseases 13. thrombocytopenia or platelet disorders (platelet count \<100,000/ul) 14. major health issues which may affect the safety of study subject, including but not limited to: * history of chronic kidney disease (egfr\<60) * long term use of medications which alter lipid metabolism * history of hepatic disease (alt or ast more than 2 times the upper limit of normal) * history of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia * chronic use of asa, anticoagulants, platelet inhibitors * use of nsaids for more than 2 weeks prior to screening * anemia (hemoglobin \<13 g/dl)
evaluating error augmentation for neurorehabilitation

Conditions: Stroke

Summary: this is a sub-project of a larger nidrr grant. one promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. in this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. using the vrroom, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. this project evaluates a practical approach of error augmentation, using therapist-driven trajectories. the investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. the investigators will test two experimental treatments in a crossover design. the investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.


Eligibility criteria:
inclusion criteria: * adult (age \>18) * survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (mca), * demonstrated the presence of some active shoulder and elbow movement (characterized by fugl-meyer assessment upper extremity scores ranging from 15-50 for arm 1; 25-50 for arm 2). exclusion criteria: * diffuse or multiple lesion sites or multiple stroke events * bilateral paresis * severe spasticity or contracture (modified ashworth ≥3 * severe concurrent medical problems * severe sensory deficits * cerebellar strokes resulting in severe ataxia * significant shoulder pain * focal tone management with botulinim toxin (botox®) injection to the hemiparetic upper extremity (ue) within the previous four months, * aphasia that would influence the ability to perform the experiment * cognitive impairment (mini mental state examination \< 23/30) * affective dysfunction that would influence the ability to perform the experiment * depth perception impairment (\< 3 on stereo circle test) * visual field cut or hemispatial neglect that would influence the ability to participate in the activity * inability to provide informed consent

Keywords: stroke error augmentation arm recovery massed practice
laser light visual cueing for freezing of gait in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with parkinson's disease.

freezing of gait is a debilitating feature of parkinson's disease. this study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. for each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

Eligibility criteria:
inclusion criteria: * idiopathic pd confirmed by a movement disorders neurologist * a mini-mental status examination (mmse)\[13\] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam * functional visual acuity for recognizing the laser beam on the rolling walker * fog in both on and off medication states, as indicated by a score of ≥ 2 on item 14 of the unified parkinson's disease rating scale (updrs) and/or ≥1 on item 3 of the freezing of gait questionnaire (fogq) * ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on items 15 and 29 of the updrs. exclusion criteria: * diagnosis of a gait disorder other than parkinson's disease

Keywords: assistive devices freezing of gait gait disorders gait hesitation gait ignition failure laser light parkinson's disease rolling walker visual cue walker
effects of long term albumin 20% administration in patients with cirrhosis and ascites.

Conditions: Cirrhosis; Ascites

Summary: effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Eligibility criteria:
inclusion criteria: * age above 18 years and less than 80 years. * diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound. * daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide * renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 meq / l. exclusion criteria: * refractory ascites (paracentesis requirements over 1 month. * neoplastic disease including liver cancer if it exceeds the milan criteria (one nodule\> 5 cm or three nodules\> 3 cm). * history of transjugular intrahepatic portosystemic shunt (tips) or surgical shunt * gastrointestinal bleeding or bacterial infection documented in the past 15 days. * heart failure or structural heart disease. * organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy). * moderate or severe lung chronic disease. * transplant. * infection with human immunodeficiency virus. * active addiction to drugs. * mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy. * pregnancy.
immediate allogeneic hematopoietic stem cell transplantation versus re-treatment for patients with high-risk acute myeloid leukemia

Conditions: AML

Summary: this study aims to investigate whether immediate hsct for patients with high-risk aml and intermediate-risk aml who have not achieved complete remission (cr) after their first induction therapy is non-inferior to re-treatment with chemotherapy.

1. disease control group: patients proceeded to allogeneic hsct as soon as possible. patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission. 2. retreatment group: receive a second course of anti-leukemic treatment prior to allogeneic hsct. the anti-leukemic treatment regimen will be determined based on the genetic mutation status. patients without targetable mutations will receive a combination of bcl-2 inhibitors and demethylating agents as salvage chemotherapy. patients with targetable mutations will receive appropriate targeted therapy (e.g., flt3 inhibitors, idh inhibitors). for patients who have already received targeted therapy during induction treatment, the researchers may choose the treatment regimen based on the individual patient's condition.

Eligibility criteria:
inclusion criteria: 1. aml patients aged ≥ 18 years. 2. high-risk aml patients according to the 2022 eln standards who received one cycle of induction therapy. 3. requires allogeneic hematopoietic stem cell transplantation (including hla-matched or mismatched allogeneic hsct and unrelated donor transplant). 4. kps score greater than 60. 5. informed consent must be signed before the start of the study procedures; if it is detrimental to the patient's condition for them to sign, the consent may be signed by a legal guardian or immediate family member. exclusion criteria: 1. acute promyelocytic leukemia. 2. patient has received more than 440 mg/m2 daunorubicin equivalents. the cumulative dose is calculated by summing up isotoxic daunorubicin-equivalents for daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone. the conversion factors are derived from the comparison of the respective maximum doses. the conversion factor is 1 for daunorubicin, 1 for doxorubicin, 0.6 for epirubicin, 4.6 for idarubicin, and 2.7 for mitoxantrone (see worksheet for calculation). 3. severe organ dysfunction, defined as: 1) left ventricular ejection fraction \ 1.5 x uln (if not considered gilbert-syndrome) or asat/alat \>5 x uln. 4) estimated glomerular filtration rate (gfr) \< 50 ml/min, where: estimated gfr (ml/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) 4. history of allogeneic transplantation. 5. manifestation of aml in the central nervous system. 6. pregnant or breastfeeding women.

Keywords: high-risk acute myeloid leukemia
prognostic value of transforming growth factor-beta 1 in normal pressure hydrocephalus

Conditions: Normal Pressure Hydrocephalus

Summary: correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

the goal of this research is to investigate a potential csf biomarker of nph as a new tool for both the diagnosis of nph and prognosis of vps placement. transforming growth factor-b1 (tgf-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 previously, tgf-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 recently, an investigation demonstrated elevated levels of tgf-b1 in patients with shunt-responsive nph compared to non-nph patients.12 the specific aims of this research proposal are to: 1. correlate csf levels of tgf-b1 with the clinical response of patients diagnosed with nph to vps placement. 2. correlate csf levels of tgf-b1 with optimal vps pressure settings.

Eligibility criteria:
inclusion criteria: * diagnosis of normal pressure hydrocephalus exclusion criteria: * patients not diagnosed with normal pressure hydrocephalus

Keywords: nph tgf-beta
minimal invasive axillary staging and treatment after neoadjuvant systemic therapy in node positive breast cancer

Conditions: Breast Cancer; Neoadjuvant Therapy; Lymph Node Metastases

Summary: today, the majority of clinically node positive (cn+) breast cancer patients is treated with neoadjuvant systemic therapy (nst). axillary staging and treatment after nst in cn+ patients are areas of controversy. patients with a pathological complete response (pcr) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (alnd). hence, less invasive axillary staging procedures are being introduced to avoid unnecessary alnd. however, evidence supporting the safety of replacing alnd by less invasive techniques in terms of oncologic safety and impact on quality of life (qol) is lacking.

the minimax is a multicenter registry study that includes node positive breast cancer patients, who are treated with nst (chemotherapy and ± immunotherapy), in order to gain insight in the oncologic safety and impact on qol of less and more invasive axillary staging and treatment strategies. patients who are included in this study will complete patient reported outcome measures (proms) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact on qol. a database will be built by the netherlands cancer registry. data on patient-, tumor-, pre-nst staging-, post-nst staging- and treatment-characteristics will be retrieved from patients' records by trained data registrars of the netherlands comprehensive cancer organisation (iknl) using electronic case report forms (ecrfs). five-year survival and recurrence will be evaluated to determine oncologic safety. the results will be incorporated in the national guidelines. in case of an equilibrium between less and more invasive strategies, the data of this study will at least be extremely suitable to be used in the shared decision making process.

Eligibility criteria:
inclusion criteria: * female patient with unilateral invasive breast cancer and cn1-3 * pathologically proven positive axillary lymph node * planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla exclusion criteria: * clinically node negative breast cancer before nst * bilateral invasive breast cancer * neoadjuvant endocrine therapy * distant metastases (including oligometastatic disease) * history of invasive breast cancer * other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast * axillary surgery or radiotherapy before nst (this includes slnb prior to nst)
effect of copper impregnated textiles on healthcare associated infections and antibiotic use

Conditions: Hospital Acquired Infection

Summary: this is a prospective infection control study comparing rates of antibiotic usage and infections in the general intensive care unit (gicu) in beds with copper impregnated linens versus regular linens.

one ward of the icu had copper impregnated linen while the other had regular linen. this included sheets, pillowcases, towels and patient gowns. after the first 23 week period was completed, there was a 3 week washout period. after this, the wards were switched with the first using regular linen and the second using copper impregnated linen. the investigators followed participants and documented any infections \>48 hours after admission to the icu. the number and days of antibiotics used for the infections were also documented. using assigned study numbers, the investigators obtained demographic data: age, sex, co-morbid conditions, and admitting diagnosis. all participants were followed daily in the gicu and daily for 48 hours after transfer to the regular floor. date of discharge will be obtained retrospectively. infection control (ic) routinely obtains methicillin resistant staphylococcus aureus (mrsa) nasal swabs on all patients on admission to the gicu, once weekly while in gicu and then again on discharge from the gicu. they monitor the gicu patients for healthcare associated infections (hai) that meet the national healthcare safety network (nhsn) 146 definitions. the nhsn is a widely used hai tracking system, and the infections documented included ventilator associated pneumonia (vap), catheter related blood stream infections (clabsi), catheter associate urinary tract infections (cauti) and clostridium difficile associated diarrhea (cdad). they also obtain information on decubitus ulcers (bed sores) that develop during hospital stay. infection control also routinely monitors the isolation of multi-drug resistant bacteria, namely vancomycin resistant enterococci (vre), extended spectrum beta lactamase producing organisms (esbl) and carbapenemase producing enterobacteriaceae (cre) as well as multi drug resistant (mdr ) acinetobacter baumanii from cultures. this above information will be obtained from the ic nurses on a weekly basis by the investigators. as most of the infections in the icu do not meet strict nhsn criteria, the investigators defined an infection as: the physician diagnosing an infection, and then initiating antibiotics for the same. copper linen were implemented the same as regular linen. there was no difference in the nursing or physician staff on either side. no interventions were made other than existing hospital wide ic interventions

Eligibility criteria:
inclusion criteria:all patients \>18 years and \<90 years who were admitted to the gicu during the study period - exclusion criteria: 1. those that did not meet the age criteria as above. 2. any patients with menke's syndrome or wilson's disease 3. any patient with an allergy to copper or iodine 4. any patient who wishes to opt out of participating

Keywords: infection control prevention of hospital acquired infection