Kornimate/medical-research-clean huggingface dataset:
bmi-associated labor induction: a prospective trial

Conditions: Labor Induction

Summary: the primary objective of this study is to determine if planned induction of labor at 39 weeks for nulliparous with pre-pregnancy bmi ≥ 35 kg/m2 reduces the incidence of cesarean section compared to expectant management

obesity in the obstetric population has reached epidemic proportions, affecting over 30% of reproductive-aged women in the united states (1). the increase in this morbidity is associated with large increases in cesarean delivery over the non-obese obstetric population and resultant post-operative complications are also higher in obese women (2). there are no interventions proven to reduce the risk of cesarean in obese women. the aim of this research study is to determine if induction of labor at 39 weeks can reduce the incidence of cesarean delivery over routine obstetric care (expectant management).

Eligibility criteria:
inclusion criteria: 1. age 18 years and older 2. pregnant, singleton gestation, vertex presentation 3. nulliparous (no prior pregnancy delivered past 20 weeks) 4. pre-pregnancy (self-reported in record of in emr within 3 months of lmp) or 1st trimester (up to and including 14 weeks 0 days) bmi ≥ 35 kg/m2 5. gestational age at enrollment 38 weeks 0 days and 38 weeks 6 days with dating confirmed by lmp and ultrasound performed prior to 20 6/7 weeks exclusion criteria: 1. plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration 2. plan for cesarean delivery or contraindication to labor 3. major illness with increased risk of adverse pregnancy outcomes (e.g. pregestational diabetes with or without medication, gestational diabetes on medication, hypertension, cardiac disease, renal insufficiency, autoimmune disorder) 4. multiple gestation 5. non-vertex presentation 6. fetal death 7. fetus with major/lethal anomaly or aneuploidy (soft markers of aneuploidy, urinary tract dilation, isolated bowel dilation, mild ventriculomegaly, normal variants of vascular system, and isolated ventricular septal defects will not be excluded) a. soft markers not qualifying as exclusion criteria: echogenic intracardiac focus, choroid plexus cyst, echogenic bowel, increased nt or nuchal fold, isolate short humerus or femur 8. fetal growth restriction (efw \<10th percentile or ac \<10th percentile) 9. preeclampsia or gestational hypertension 10. known oligohydramnios or polyhydramnios 11. prior delivery after 20 weeks 12. placenta/vasa previa 13. placental abruption (known or suspected) or unexplained vaginal bleeding 14. previous cesarean section, myomectomy, or classical cesarean 15. spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes 16. active genital herpes or hiv positive 17. inability to consent 18. any contraindication to a vaginal delivery 19. delivery anticipated outside of baystate medical center

Keywords: bmi obesity labor induction cesarean section
assessing changes in myocardial tissue and blood in patients with advanced heart disease

Conditions: Congestive Heart Failure

Summary: hypothesis: tissue and serum samples collected from end-stage heart failure patients receiving left ventricular assist device implantation (lvad) or heart transplantation will provide information regarding the basic science of heart disease. tissue and serum samples collected from a limited numbers of "healthy controls" (donor grafts that were not utilized for heart transplantation) will serve as a comparator in research database projects. design: this is a registry project; there are no investigational treatments, drug or procedures associated with participation in registry activities. this project is an organized functional data and tissue data gathering and storing (database) endeavor with specific focus on the functional, structural, and molecular aspects of heart failure. data collection will not immediately influence the course of treatment for any patient.

brief description of procedures: after informed consent is obtained from the patient, the blood samples will be obtained either during a procedure from access lines inserted for the procedure or they will be drawn when other ordered lab work is done at specific time points during the study. tissue samples will be obtained at the time of lvad implantation by keeping the part of the left ventricular apex that the surgeon is removing in order to place the inflow cannula of the lvad. no extra tissue sample, other than the tissue that has to be removed as a part of a standard lvad, will be collected.

Eligibility criteria:
inclusion criteria: * \>18 years of age diagnosed with heart failure undergoing either lvad implantation or heart transplantation * 13 to 18 years of age, specifically, older children with heart failure whose body mass index is large enough to accommodate and lvad exclusion criteria: * neither patient nor patient representative understands spoken english * neither patient nor patient's personal representative is willing to give written consent for participation.

Keywords: congestive heart failure left ventricular assist device lvad myocardium remodeling microvasculature fibrosis cardiac transplant
study switching hiv-1 infected patients with an undetectable viral load on a first protease inhibitor-based regimen to an efavirenz-based regimen

Conditions: HIV Infections

Summary: the purpose of this study is to demonstrate that virologically controlled hiv-infected individuals can successfully switch from a protease inhibitor (pi)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma hiv-1 levels \< 50 copies/ml. in addition, a simplified once-daily regimen will improve adherence and quality of life.

patients randomized to the non videx enteric coated (ddl ec)+lamivudine (3tc)+efavirenz (efv) arm would continue their baseline nucleoside reverse transcriptase inhibitors (nrtis) on study.

Eligibility criteria:
inclusion criteria: * documented hiv infection * ≥ 18 years of age and weight at least 40kg * two plasma hiv rna levels \< 50 copies/ml during the qualification and screening period * patients receiving a pi and ≥ 2 nrtis exclusion criteria: * pregnancy or breastfeeding * documented virologic failure while on their first pi-based antiretroviral (arv) regimen * active aids-defining opportunistic infection or disease * proven or suspected acute hepatitis within 30 days prior to study entry

Keywords: hiv/aids
tiotropium / respimat one-year study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate the long term effects of treatment with two doses of tiotropium delivered by the respimat inhaler in patients with copd.


Eligibility criteria:
criteria * patients with stable moderate to severe copd and a smoking history of at least 10 pack years were eligible for inclusion in the study. patients with significant diseases other than copd were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.
trial for localised high-risk rhabdomyosarcoma and rhabdomyosarcoma-like soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with o-tie (etoposide, idarubicin, trofosfamide) for 6 months improves the event free survival (efs) in patients with localised high-risk rms and rms-like soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available * pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (rms) or rms-like soft tissue sarcoma (sts) and tumour material available for pathology review * rhabdomyosarcoma of the "high risk" group, i.e.: * rme, n0, m0, irs ii\&iii, \>5 cm or \>10 years in ext, hn-pm, oth, ug-bp * rme, n1, m0, any irs-group, any size or age * rma, no, m0, any irs-group, any size or age (exception: paratesticular rma are not eligible) or * rhabdomyosarcoma of the "very high risk" group, i.e.: * rma, n1, mo, irs ii\&iii, any size or age or * localised high-risk rms-like soft tissue sarcoma, i.e.: * ees, ppnet, uds: any n, m0, any irs-group, any size or age * sysa, any n, m0, any size or age (exception: sysa irsi\&ii, not t2b, n0, m0 are not eligible) * no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity) * no previous malignant tumours * available for long term follow up through the treating centre * in remission (according to the cws-2007-hr definition (see x7.1.8x)) at the time of randomisation after standard multimodal therapy e.g. according to the cws-guidance exclusion criteria: * pregnant or lactating women * other medical condition precluding treatment with protocol therapy (e.g. hiv, psychiatric disorder, etc.) * for sexually active females and males in arm b (o-tie treatment): refusal to use effective contraception (e.g. oral, iud)

Keywords: pediatric soft tissue sarcoma rhabdomyosarcoma extraosseous ewing family tumours synovial sarcoma undifferentiated sarcoma
optimal management of women with wrist fractures

Conditions: Osteoporosis; Osteopenia

Summary: to evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. the intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.

numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. this care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society. comparison: cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. comparison is to women and their physicians who receive standard post fracture information. family practices are randomized to intervention or non-intervention group.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women with low trauma distal radius fracture (confirmed by x-ray). 2. can be taking didrocal (etidronate), miacalcin (calcitonin),or hormone replacement therapy . exclusion criteria: 1. women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture). 2. significant cognitive impairment (which would preclude them from filling out simple questionnaires). 3. women already taking osteoporosis therapy, ie. either fosamax (alendronate), actonel (risedronate), or the selective estrogen receptor modulator, evista (raloxifene).

Keywords: osteoporosis wrist fractures knowledge translation implementation educational reminder
effects of lubiprostone on small bowel and colonic bacteria: a correlation study with segmental and whole gut transit

Conditions: Constipation

Summary: patients with constipation often have bloating and abdominal distension. it is unclear if this is related to intestinal bacteria. hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.

this is an open-label study to collect data on upper and lower gi symptoms, hydrogen breath test, stool pcr, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.

Eligibility criteria:
inclusion criteria: functional constipation by rome iii criteria exclusion criteria: 1. history of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery) 2. history of small bowel or colon resection (excluding appendectomy and cholecystectomy) 3. history of gastric outlet, small bowel, or colon obstruction 4. history of surgery for small bowel adhesion lysis 5. history of surgery for gastroparesis 6. diagnosis of diabetes requiring daily medications 7. diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder) 8. diagnosis of neuromuscular disorder (including multiple sclerosis, parkinson, muscular dystrophy, dysautonomia, dystonia) 9. disorders of small bowel pseudo-obstruction or dumping syndrome 10. untreated or poorly controlled hypothyroidism 11. taking an opiate medication daily 12. taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.) 13. active cancer being treated 14. history of significant liver, kidney, cardiac disease that may interfere with study compliance 15. known allergy or side effects to lubiprostone 16. non-ambulatory patients: bed-ridden, nursing home resident, etc.

Keywords: constipation small intestinal bacterial overgrowth stool bacteria
mirnas evaluate the prognosis of sepsis

Conditions: Sepsis

Summary: sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. mirna is a post-transcriptional small rna which regulate mrna expression. the present study was designed to screen several mirna by microarray which evaluate the sepsis prognosis in order to be a new target for the treatment of sepsis.

the study is a non-intervention, prospective observational study. purpose of this sudy is to screening several mirnas by microarray which can evaluate the prognosis of sepsis . we will collect serum samples from patients with sepsis in sicu, ricu and eicu of 301 hospital since september 2009 , and then use the chip and qrt-pcr to screen mirnas which can evaluate the prognosis of sepsis, and statistical analysis the mirnas expression correlation with sofa score.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sepsis * patients who agree with the study exclusion criteria: * aged \<18 years; * into the group who died within 24 hours; * agranulocytosis (\<0.5 × 109 / l); * combined hiv infection.

Keywords: sepsis mirna
the effect of active breathing exercises for elderly people in the community

Conditions: Swallowing Disorder

Summary: the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

the investigators have designed a simple and user-friendly training method called "active breathing exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.
dose escalation study of ec d-3263 hcl in advanced solid tumors

Conditions: Solid Tumors

Summary: this is a phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated d-3263 hcl in subjects with advanced solid tumors


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists * measurable or evaluable disease * \>= 18 years of age * ecog of 0, 1 or 2 * no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot lhrh agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of ec d-3263 hcl exclusion criteria: * clinically significant coronary artery disease or conduction system abnormality * coagulation disorder * active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of ec d-3263 hcl * any major surgery within 28 days prior to receipt of ec d-3263 hcl

Keywords: subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.
hidradenitis suppurativa (hs) tunneling wounds

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to look at the change in the microbiome (bacterial composition) of an hs tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (abwg) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.


Eligibility criteria:
inclusion criteria: 1. adults 18 years old and older 2. have diagnosis of hs confirmed by a dermatologist 3. have at least one hs related tunneling wound that is at least 2 centimeters in length 4. able to provide informed consent exclusion criteria: 1. individuals who are not yet adults 2. women known to be pregnant 3. prisoners 4. subjects, who in the opinion of the pi, cannot comply with home application of the treatment.

Keywords: tunneling wound
evaluation of long-term health status and quality of life in adult survivors with philadelphia-negative acute lymphoblastic leukemia/lymphoma treated with an intensive pediatric or pediatric-inspired protocol

Conditions: Acute Lymphoblastic Leukemia; Acute Lymphoblastic Lymphoma

Summary: the overall survival of adult patients (15-59y) with philadelphia-negative acute lymphoblastic leukemia/lymphoma (all/ll) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (graall2003/05-ll03-fralle2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. this approach led to a global improvement in overall survival (5y-os, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-trm in patients \> 45y, 19%). pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. this study aims to evaluate the impact in term of long-term events and qol in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. the main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for all/ll with an intensified pediatric-inspired protocol (graall2003/05-ll03-fralle2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. one of the secondary endpoint of the study is to assess quality of life of these patients.


Eligibility criteria:
inclusion criteria: * patient with philadelphia-negative all or ll treated in or according to a pediatric-like or pediatric-inspired protocol (graall03/05-ll03-fralle2000) with or without allogeneic transplant. * patients older than 15 years old and less than 60 years old at diagnosis * patient with a follow-up from first complete remission of more than 10 years, * patient who gave informed signed consent for baseline examination exclusion criteria: * patient who experienced all/ll relapse within the 5 past years. * philadelphia positive all patients
the biomarker and cardiac function in sepsis

Conditions: Sepsis

Summary: the development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.


Eligibility criteria:
inclusion criteria: * sepsis patients with 2 of the followings when arrival er and treated \> 6 hours: * bt \>38℃ or\<36℃ * hr \>90/min * rr \>20/min or paco2 \< 32 mmhg * wbc count \>12×109/l or \ 10％ exclusion criteria: * age \< 18 * major trauma patients * pregnancy * willing to do not aggressive treatment