Kornimate/medical-research-clean huggingface dataset:
analysis of the status, treatment and outcomes of rib fractures

Conditions: Rib Fracture; Trauma

Summary: a retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of penn state hershey medical center between 2010-2012. patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.

this is a retrospective chart review with follow-up phone calls. the initial part of the study will be a retrospective chart review. for this chart review study, the following data elements will be entered for each participant. the investigators will perform a retrospective study of patients who have been treated for rib fractures at penn state hershey medical center (pshmc). the time period of review will be 1/10/10 - 1/10/12 until 1500 cases have been reviewed. data collected will be: * patient medical record number (mrn) * name * phone number * length of stay (admit and discharge date) * number of rib fractures per patient * cause of rib fracture * characteristics of the fracture (unilateral versus bilateral and multiple versus single) * pain management used for the rib fracture including pain interventions, medications and all pain scores * complications attributable to the rib fracture, including: 1. shortness of breath (sob) 2. hemothorax, 3. pneumothorax 4. flail chest 5. intubation required 6. mechanical ventilation required 7. opioids required for pain 8. chest tube placement required * sequelae of rib fracture, including: 1. acute respiratory deficiency syndrome (ards) 2. pneumonia 3. death 4. chronic pain 5. delayed subclavian vessel thrombosis 6. aortic aneurysm 7. tracheobronchial fistula 8. thoracic outlet syndrome 9. horner's syndrome * clinical history of 1. rib fractures 2. other fractures 3. osteoporosis 4. chronic obstructive pulmonary disease (copd) 5. cancer 6. myocardial infarction (mi) / coronary artery disease (cad) 7. arthritis 8. parkinson's disease * patient characteristics: 1. age 2. gender 3. race 4. body mass index (bmi) 5. alcohol use 6. smoking status 7. marital status 8. education 9. initial blood pressure 7.2.2 follow-up phone calls the investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information: 1. pain score 2. quality of life via the euroqol's quality of life survey :eq-5d-3l questionnaire 3. pain meds

Eligibility criteria:
inclusion criteria: * must have above and be notated in our medical record exclusion criteria: * missing data
blood conservation in patients (3.5-12kg) undergoing congenital cardiac surgery

Conditions: Congenital Heart Disease

Summary: to evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. the main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter icu and hospital length of stay.


Eligibility criteria:
inclusion criteria: * patient weight 3.5-12kg * elective and urgent cardiac surgery with cardiopulmonary bypass * cases within the sts stat categories of 1-4 exclusion criteria: * patients who weigh more than 12kg or less than 3.5kg. * patients undergoing emergency surgery. * stat category 5 cases. * patients whose surgery does not require cardiopulmonary bypass. * patients presenting preoperatively in shock. * patients with known blood dyscrasias.
prospective randomized trial of streamlined genetic education and testing for ovarian cancer patients

Conditions: Ovarian Cancer, Epithelial; Peritoneal Cancer; Fallopian Tube Cancer

Summary: current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. the purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. patients will be randomized to either the streamlined or the traditional counseling arm. those in the streamlined group will watch a brief educational video and have the option of immediate testing; the traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. the primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. the study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.


Eligibility criteria:
inclusion criteria: * either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with high-grade epithelial ovarian cancer. * presenting to duke gynecologic oncology clinic or collaborating institution for first outpatient visit following pathologic or cytologic diagnosis. if logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy. exclusion criteria: * known family or personal history of an inherited cancer susceptibility mutation * previously received genetic counseling or testing for an inherited cancer susceptibility mutation * insurance provided by an insurance company that requires face-to-face genetic consultation prior to testing * unable to read or speak english as study design includes video assisted educational materials in english * blind or deaf as study design includes video assisted educational materials in english
clonidine and left ventricular dysfunction

Conditions: Ventricular Dysfunction

Summary: the objectives of this study are: 1. to evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (dhf). 2. to evaluate the effect of clonidine on neurohormones and quality of life in patients with dhf. the study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with dhf. a total of 70 patients with dhf will be randomized in a 1:1 ratio to: 1. placebo (n=35) or to 2. clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months. the primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (mri) and echocardiography.


Eligibility criteria:
inclusion criteria: * age: 60 and greater * gender: both * patients with heart failure new york heart association (nyha) ii and ejection fraction over 45%

Keywords: heart failure diastolic functionclonidine left ventricular diastolic dysfunction with preserved ejection fraction
analyses of interleukin-6, presepsin and pentraxin-3 in the diagnosis and severity of late-onset preeclampsia

Conditions: Preeclampsia

Summary: introduction: the etiology/pathophysiology of preeclampsia remains an enigma. cellular immunity is a key factor in the etiology of late-onset preeclampsia (l-pre). presepsin is split out from the phagocytes membranes after phagocytosis. to investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women. methods: the investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without l-pre (n=44). these three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.

this observational case-control study was designed at cengiz gokcek women's and children's hospital, gaziantep, turkey, in the department of obstetrics and gynecology between june 2018 and january 2019. the protocol was approved by the ethics committee for clinical research of gaziantep university (reference number: 2018/393). the study strictly adhered to the principles of the declaration of helsinki. all subjects included in the study gave oral and written informed consent. eighty-eight women were enrolled in the study in two groups. all participants will gave their oral and written informed consent before their inclusion in the study.

Eligibility criteria:
inclusion criteria: * preeclampsia healthy pregnancy exclusion criteria: 1. pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases), 2. using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin), 3. pregnant women who had fever at the time of the first admission, 4. concurrent infections (urinary tract infection, cervicitis, etc.), 5. pregnancies complicated with premature membrane rupture or chorioamnionitis, 6. history of medication for pe treatment at the time of the first admission, 7. patients who had fetal congenital abnormalities or genetic syndromes, 8. drug user, 9. multiple gestations, 10. active labor.

Keywords: innate immunity macrophage toll-like receptors trophoblasts phagocytos
investigation of the effects of diet on the measurement of plasma chromogranin in net patients

Conditions: Neuroendocrine Tumors

Summary: measurement of plasma chromogranin a remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (gep-net), despite several limitations that include: lack of a reference cga standard; wide variations depending on the used assay in different laboratories; and varying sensitivity ranges from 60 to 90% with low specificity \<50%, depending on the population studied. surprisingly, and to the best of our knowledge, only three studies with small numbers of participants have been published that have investigated possible effects of food intake on the measurement of cga. most have been performed in healthy controls or patients on treatment with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study has investigated patients with gep-net, where n = 6 patients with gastric net were included. in this study, the investigators aim to assess the time dependent effects of normally ingested diet (5-item english breakfast; or tea or coffee; or ongoing fasted state) on plasma chromogranin a measurements, using timed measurements over 180 min following an \> 10 hours overnight fast, in a randomised double-crossover design. the investigators aimed to include 25 - 35 patients with a histologically confirmed diagnosis of a gep-net of varying primary tumour location, tumour stage, grade; and presence or absence of treatment with long acting somatostatin analogues; as well as 10 - 15 healthy controls. in an additional small subgroup of patients who are initiated on treatment with glp-1 analogues i.e. for type 2 diabetes or obesity, the investigators aim to establish whether injection of glp-1 analogues has any effects on plasma cga measurements.


Eligibility criteria:
inclusion criteria: gep-net patients: * confirmed diagnosis of net * aged 18 or over * able to provide written informed consent * able to commit to 3 visits within a 4 week period * able to fast overnight * able to adequately read/write/speak english controls: * no known diagnosis of net * aged 18 or over * able to provide written informed consent * able to commit to 3 visits within a 4 week period * able to fast overnight * able to adequately read/write/speak english exclusion criteria: - gep-net patients * no confirmed diagnosis of a net * under the age of 18 * unable to provide written informed consent * pregnant women * any patients who are un well on the day of their routine appointment * unable to fast overnight * unable to adequately read/write/speak english controls * confirmed diagnosis of net * under the age of 18 * unable to provide written informed consent * pregnant women * any patients who are un well on the day * unable to fast overnight * unable to adequately read/write/speak english
reduction of bk viremia in kidney transplant patients

Conditions: Kidney Diseases; Kidney Transplant Infection; Kidney Transplant; Complications

Summary: reduction of bk viremia by treating kidney transplant patients.

a clinical investigation plan (cip) for the "reduction of bk viremia in kidney transplant patients using the seraph 100 microbind® affinity (seraph 100) blood filter" clinical study, where bk is an abbreviation of the name of the first patient whom the virus was isolated from in 1971. this clinical study is intended to evaluate the reduction of bk viremia by treating kidney transplant patients with the seraph 100 microbind® affinity blood filter from exthera medical. this clinical study is sponsored by exthera medical corporation. this clinical study will be conducted in accordance with this cip. all parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.

Eligibility criteria:
inclusion criteria: 1. kidney transplant patients with a bk-viraemia ≥ 10,000 iu/ml. 2. be ≥ 18 years old and ≤ 90 years old 3. existing hemodialysis access exclusion criteria: 1. subject is currently participating in another clinical investigation 2. pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 3. presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 4. have child-pugh class c cirrhosis 5. have platelet count \<30.000/ul 6. contraindications for heparin sodium for injection 7. subjects demonstrating any contraindication for this treatment as described in the ifu 8. patients without existing hemodialysis access

Keywords: bk virus
efficacy and safety of plasma exchange with albumin in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: pilot, phase ii, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of amyotrophic lateral sclerosis (als).


Eligibility criteria:
inclusion criteria: * signed written-informed consent. * subjects over 18 years of age, and less than 70 years old. * subjects with a definite, possible, or probable diagnosis of als, according to the revised el escorial criteria. * subjects having experienced their first als symptoms within 18 months before recruitment/consent. * fvc \> 70% * subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study. exclusion criteria: * subjects with a clinically significant preexisting lung disease not attributable to als. * subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of als. * participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study. * female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study. * difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol * any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team * a history of frequent adverse reactions (serious or otherwise) to blood products. * hypersensitivity to albumin or allergies to any of the components of albutein. * subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants * plasma creatinine \> 2mg/dl. * present a history of heart disease including ischemic heart disease or congestive heart failure. * presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment * any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)

Keywords: plasma exchange albumin
obe001 phase 2 dose-finding study versus placebo in women undergoing embryo transfer in the context of ivf-icsi

Conditions: Infertility

Summary: the primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of obe001, an oral oxytocin antagonist, compared to placebo.

the study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist obe001 in 240 women undergoing embryo transfer following ivf or icsi. the four-arm study (obe001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of obe001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

Eligibility criteria:
key inclusion criteria 1. women with medically indicated ivf or icsi using her own oocytes. 2. gnrh antagonist protocol, a single injection of hcg for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone. 3. evidence of uterine contractions by transvaginal ultrasound at baseline. key exclusion criteria 1. blastocyst stage or frozen-thaw transfers 2. clinically significant abnormalities in ecg, vital signs, physical examination or clinical laboratory results 3. severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Keywords: ivf icsi
influence of a liquid oat bran product on blood glucose in patients with poorly controlled type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Obesity; Overweight; Metabolic Syndrome

Summary: this study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. in the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. after the first 6 weeks both groups will be switched to the high fiber product.

it has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. in addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. in this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. the primary endpoint will be fasting glucose after 6 weeks. secondary endpoints will be long-term glucose control as measured by hba1c, self-documented glucose as well as the body weight and body mass index.

Eligibility criteria:
inclusion criteria: * type 2 diabetes with inadequate glucose control and a hba1c \>7,5 and \< 9% * treatment with all oral antidiabetic medication or injectable glp-1 analogues * bmi 28,0-39,9 kg/m² * age 30-70 years exclusion criteria: * insulin treatment * psychiatric disease * acute infections * alcohol or drug abuse * acute diverticulitis * malignant tumors or hematologic disorders * heart failure nyha iii-iv * acute coronary syndrome * chronic kidney disease \> stage 3 (kdoqi) * pregnancy or lactation * previous bariatric interventions

Keywords: fiber type 2 diabetes dietary intervention weight loss glucose control obesity overweight metabolic syndrome oats
phase ii trial of zd1839 (iressa) in patients with nonresectable adrenocortical carcinoma (acc)

Conditions: Nonresectable Adrenocortical Carcinoma

Summary: the use of iressa will result in a greater than 20% response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy (either mitotane or chemotherapy).

adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people in the united states. surgery is the only potentially curative option. current systemic therapy, either mitotane or chemotherapy, typically gives response rates of 20% or less. this study is designed to see if the newer targeted therapy, iressa, may be of benefit for patients with this fatal disease. patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy (mitotane or chemotherapy) will be given iressa 250 mg by mouth daily until disease progression. this is a standard two-stage phase ii clinical trial. eighteen patients with measurable disease will be enrolled in the first stage. if there is at least one responder, then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease. up to six patients without measurable disease may be enrolled at any point in this study. iressa will be provided free for all study participants.

Eligibility criteria:
inclusion criteria: * subject must be able to provide informed consent * subject must be 18 years of age or older * subject must have histologically confirmed acc by department of pathology at dartmouth hitchcock medical center * subject must have inoperable disease * subject must have received some form of systemic therapy prior to enrolling in the study exclusion criteria: * known severe hypersensitivity to iressa * other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ * any unresolved ctc grade 2 toxicity from previous anticancer therapy (except alopecia) * absolute neutrophil count less than 1.5 x 1,000,000,000 per liter * platelets less than 20 x 1,000,000,000 per liter * severe uncontrolled systemic disease * pregnancy\\breastfeeding * women who are fertile and not willing to practice abstinence or contraception * use of phenytoin, carbamazepine, rifampicin, barbiturates, or st. john's wort * treatment with a non-approved or investigational drug within 28 days before day 1 of study treatment * prior use of zd1839 (iressa) or any other anti-egfr therapies

Keywords: adrenocortical cancer iressa adrenal cancer
a phase 2 study of punctal placement of the latanoprost punctal plug delivery system (l-ppds)

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the study objective is to compare iop and safety outcomes based on plug placement (upper or lower puncta).


Eligibility criteria:
inclusion criteria: * over 18 years * diagnosed with bilateral open-angle glaucoma or ocular hypertension exclusion criteria: * uncontrolled medical conditions * subjects who wear contact lenses * subjects requiring chronic topical artificial tears, lubricants, and /or requiring any other chronic topical medications

Keywords: glaucoma