Kornimate/medical-research-clean huggingface dataset:
double simultaneous uterotonic agents versus single agent regimen to prevent early postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: to determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage. there have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage. specific aim 1: determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage. specific aim 2: determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

postpartum hemorrhage (pph) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. most cases of pph can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. efforts to prevent uterine atony and thereby pph have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). universal standard of care to prevent postpartum hemorrhage, according to the american college of obstetrics and gynecologists and world health organization includes various dose infusions of oxytocin. additional uterotonics are given if necessary, according to noted blood loss and uterine tone. the best uterotonic(s), combination, route, and dose, however, remain actively debated. randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. a cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing pph in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. in an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of pph, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).

Eligibility criteria:
inclusion criteria: - all women 18 years and older admitted to delivery at stony brook university hospital who agree to participate in the study exclusion criteria: * women under 18 years old * women with known coagulation disorders * women with planned cesarean hysterectomy * women with known placental accreta spectrum disorders * women with known allergy to prostaglandins
study of cs-1008 in patients with advanced solid malignancies and lymphomas (without leukemic component)

Conditions: Malignancies; Lymphoma

Summary: this is a dose escalation study of cs-1008 (humanized anti-dr5 antibody) to determine the recommended phase 2 dose and the maximum tolerated dose. drug will be administered for six weeks and possibly up to 12 weeks depending on response.


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s). * eighteen years of age or older * eastern cooperative oncology group (ecog) performance status equal to or less than 2 * resolution of any toxic effects (except alopecia) of prior therapy to national cancer institute common terminology criteria for adverse events (nci ctcae) v3.0 grade of equal to or less than 1 * men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter. * all female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to treatment * patients must be fully informed about their illness and the investigational nature of the study protocol exclusion criteria: * anticipation of the need for a major surgical procedure or radiation therapy during the study * treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin c, immunotherapy, biological therapy, or major surgery) of study enrollment * cumulative radiation therapy to greater than 25% of the total bone marrow * any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association (nyha) class iii or iv congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease \[copd\] or asthma) * patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy \[rt\]; or with progression 4 weeks after the completion of rt) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis * clinically significant active infection which requires antibiotic therapy, or hiv-positive patients receiving antiretroviral therapy. * chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction

Keywords: apoptosis death receptor 5 cancer advanced solid malignancies and lymphomas (without leukemic component)
application of ventilator-associated events (vae) in ventilator-associated pneumonia (vap) notified in brazil

Conditions: Ventilator-Associated Pneumonia; Healthcare-Associated Pneumonia; Healthcare Associated Infection

Summary: multicentric observational prospective cohort study in 12 (twelve) hospitals representing all brazilian regions. the main objective of this project is to evaluate the incidence of ventilator-associated pneumonia (vap) when using the current anvisa criteria for vap versus vae criteria defined by the national healthcare safety network (nhsn). the diagnostic accuracy of the two criteria for identifying vap will also be compared, characterizing other events associated with mechanical ventilation that are not vap, when applicable. the study also aims to adjudicate ventilator-associated pneumonias reported to anvisa using current epidemiological diagnostic criteria.

the study will be carried out in about 12 centers, comprising the five brazilian regions. it will be conducted from 2022 to 2024. data collection will be performed at each center during six months. trained health professionals from infections control committees of each participating center will collect data. mechanical ventilation data will be entered daily in the database system from the moment the patient is submitted to mechanical ventilation until the first day after the end of mechanical ventilation. vaps notified to anvisa, according to its own criteria, will be reported monthly in the database system for adjudication. the vae definition will be performed automatically in the database system by mans of a specific algorithm. the diagnosis established by the system will be manually validated by a nurse with experience in healthcare-associated infection (hai) surveillance. agreement variables (kappa) between the two criteria will be analyzed. the adjudication will be carried out by two independent professionals (doctor and nurse) with experience in hais surveillance. in case of disagreement, there will be an evaluation by a third adjudicator. the complete project was submitted to the local institutional review board (irb)/national research ethics commission (conep) system and has ethical approval (caae: 52354721.0.1001.0070).

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * pacients hospitalized in intensive care units (icus) using mechanical ventilation exclusion criteria: * patients withdrawn from mechanical ventilation (mv) on the first day (d1) or second day (d2), with d1 being the day of initiation of mv; * patients with hospital discharge (discharge, death or transfer) on d1 or d2 of mechanical ventilation

Keywords: pneumonia surveillance healthcare associated infections ventilator-associated pneumonia healthcare-associated pneumonia
role of mri in diagnosis of postpartum neurological disorders

Conditions: Role of MRI in Diagnosis of Postpartum Neurological Disorders

Summary: role of mri in diagnosis of postpartum neurological disorders


Eligibility criteria:
inclusion criteria: 1. female gender. 2. age more than 18 years old. 3. patients presented with neurological complaint in 3 months following childbirth. exclusion criteria: 1. male gender. 2. female younger than 18 years old 3. contraindication to perform mri examination. these include:- cardiac pacemaker.- metallic aneurysm clips.
duloxetine potentiates the analgesic efficacy of intrathecal morphine

Conditions: Acute Pain

Summary: duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. there are few studies examining its effect for acute pain. the objective of this study is to evaluate the analgesic effect of duloxetine combined with intrathecal morphine for patients subjected to major abdominal cancer surgery


Eligibility criteria:
inclusion criteria: * adult patients, subjected to major abdominal cancer surgery exclusion criteria: * patients on chronic opioid therapy * patients allergic to study drugs (duloxetine+morphine) * patients have uncontrolled hypertension and or ischemic heart disease
parentcorps: promoting healthy development in children from low income communities

Conditions: Behavior Problems of Childhood and Adolescence

Summary: the purpose of this study was to determine whether parentcorps promotes academic achievement and prevents mental health problems in children living in disadvantaged urban communities


Eligibility criteria:
inclusion criteria: * enrollment in pre-k * at least one english-speaking caregiver exclusion criteria:

Keywords: early childhood universal prevention
predictive factors of response to somatostatin analogues in acromegalic patients with persistent disease following surgery

Conditions: Acromegaly

Summary: the objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.


Eligibility criteria:
inclusion criteria: * acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery exclusion criteria: * patients not contributing enough material for a tumour histopathological study * patients who have received radiation therapy or will receive it during the observational study period * patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist * patients with a history of hypersensitivity to somatostatin analogues
n-methyl glycine (sarcosine) for the treatment of obsessive compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (ocd). sarcosine, also known as n-methylglycine, is an endogenous antagonist of glycine transporter-i (glyt-i), which potentiates glycine's action at the glycine site of n-methyl-d-aspartate (nmda) receptors. in this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in ocd patients.


Eligibility criteria:
inclusion criteria: * a primary ocd according to dsm-iv * at least 1 year's duration of oc symptoms and a minimum severity score of ≥16 on yale-brown obsessive compulsive scale * drug naïve at study entry or * being free from psychotropic medication for at least 8 weeks at study entry,or * inadequately responded to ongoing psychotropic medications at study entry (defined by a y-bocs score of ≧16 despite treatment with maximum tolerated dose of a sri medication for at least 8 weeks) exclusion criteria: * patients with moderate to severe depression defined by a 21-item hamilton depression rating scale score of \>17, * a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by dsm-iv, or if they were at significant risk of suicide, and * with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease

Keywords: obsessive compulsive disorder sarcosine glycine transporter i nmda receptor
ccsh (compassion-centered spiritual health) for teams

Conditions: Health Behavior

Summary: emory spiritual health has developed a compassion-centered spiritual health group-based intervention, called ccsh interventions for teams, and are enrolling staff and providers into the groups in this randomized study design. the groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total). the investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. employees (n = 80; nurses, advanced practice providers (apps), physicians, staff) working at an nci- designated comprehensive cancer center will be randomized by team (8-12 employees/group) to compassion centered spiritual health team intervention (ccsh-ti) or tau (treatment as usual) group. the research objective is to evaluate the feasibility and acceptability of ccsh-ti, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.

current interventions to reduce provider burnout are only minimally effective. to overcome the barriers to achieving success in burnout prevention interventions, the investigators propose compassion centered spiritual health team intervention (ccsh-ti), a 4-session intervention delivered by healthcare chaplains to mixed-role interprofessional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. the research team will conduct a mixed-method feasibility and acceptability study of ccsh-ti with mixed-role oncology teams. employees (n = 80; nurses, advanced practice providers (apps), physicians, staff) working at an nci-designated comprehensive cancer center will be randomized by team (8-12 employees/group) to ccsh-ti or to tau (treatment as usual) group, who has access to all well-being resources and activities available to them as employees. self-report surveys and focus group discussions will be used to evaluate the feasibility and acceptability of ccsh-ti. the investigators will also collect self-report surveys, ecological momentary assessments (ema), and the electronically activated recorder (ear) data at 3 timepoints (before ccsh-ti (t1), immediately after completion of ccsh-ti (t2), and 12-weeks after completion (lt), and characterize data completion to evaluate the feasibility of data collection methods for a future randomized control trial. informed consent will be obtained from study participants in-person. the duration of the study will be 22-23 weeks (from consent to completion of data collection).

Eligibility criteria:
inclusion criteria: * full-time employees working in oncology teams at winship cancer institute; * employees working in intensive care at emory university st. joseph hospital. exclusion criteria: * less than 18 years old

Keywords: behavioral intervention healthcare provider burnout
hypofractionated whole pelvic radiotherapy of the prostate

Conditions: Prostate Cancer

Summary: this is a phase i feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by nccn risk criteria. patients will have \>15% risk of lymph node involvement as defined by the roach equation 2/3(psa)+10(gleason score-6). day 0 of the study will be defined as the time of first lhrh/agonist/antagonist injection of hormone therapy. radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first lhrh agonist/antagonist injection. patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. a history and physical, psa, testosterone and epic-26 questionnaire will be collected at each visit. any toxicity according to ctcae v. 4.0 criteria will be documented. an interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. the trial will be terminated if \>30% acute grade 2 or \>5% grade 3 or greater toxicity is observed as a result of radiation treatment by ctcae v. 4.0 criteria. grade 2 toxicity is defined as a minimal, local or noninvasive intervention. grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. previous studies have demonstrated approximately 30% and 5% incidence of grade 2 and grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed intermediate- to high-risk prostate adenocarcinoma (t1c-t3b, psa \>10, and/or gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the roach equation. * history/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * zubrod performance status 0-2 * age ≥18 years * ability to understand a written informed consent document, and the willingness to sign it exclusion criteria: * prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * previous pelvic irradiation, prostate brachytherapy * previous or concurrent cytotoxic chemotherapy for prostate cancer * patients with history of inflammatory bowel disease or major bowel surgery. * prior transurethral resection of the prostate (turp) procedure.
blinatumomab in adults with relapsed/refractory philadelphia positive b-precursor acute lymphoblastic leukemia

Conditions: Relapsed/Refractory Philadelphia Positive B-precursor ALL

Summary: the primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (crh\*) in adults with relapsed/refractory philadelphia chromosome positive (ph+) b-precursor acute lymphoblastic leukemia (all) who receive blinatumomab.

this is a single-arm simon ii stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety follow-up visit 30 days after treatment. following the safety follow-up visit, participants will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.

Eligibility criteria:
inclusion criteria * patients with ph+ b-precursor all, with any of the following: * relapsed or refractory to at least one second generation tyrosine kinase inhibitor (tki) (dasatinib, nilotinib, bosutinib, ponatinib) * or intolerant to second generation tki and intolerant or refractory to imatinib mesylate * greater than 5% blasts in bone marrow * eastern cooperative oncology group (ecog) performance status ≤ 2 * age ≥ 18 years of age, at the time of informed consent. * subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. exclusion criteria * history of malignancy other than all within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease * history or presence of clinically relevant central nervous system (cns) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis * active all in the cns or testes * isolated extramedullary disease * current autoimmune disease or history of autoimmune disease with potential cns involvement * allogeneic hematopoietic stem cell transplantation (hsct) within 12 weeks before blinatumomab treatment * active acute or extensive chronic graft-versus-host disease (gvhd) which included the administration of immunosuppressive agents to prevent or treat gvhd within 2 weeks before blinatumomab treatment * immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic hsct at the time of enrollment.

Keywords: relapsed; refractory; philadelphia positive; b-precursor; acute lymphoblastic leukemia; all; blinatumomab; leukemia;
safety study of single administration post-exposure prophylaxis treatment for ebola virus

Conditions: Ebola Hemorrhagic Fever

Summary: the purpose of this study is to characterize the safety and pharmacology of single administrations of avi-6002, a post-exposure prophylaxis candidate treatment for ebolavirus.

ebola hemorrhagic fever (ehf) is a rare human disease caused by ebola virus (ebov), a filamentous single-stranded, negative-sense rna virus. since 1976 several ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single ebov species; ebov-z. no effective therapy is currently available for ebolavirus. avi-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (pmoplus™). these oligomers specifically target viral messenger rna encoding 2 ebolavirus proteins thought to be important in viral replication and host immune suppression. the present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of avi-6002 in healthy human subjects.

Eligibility criteria:
inclusion criteria: * male or female and between the ages of 18 and 50 years in good general health * volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential * volunteers must be willing to undergo a urine screen for drugs of abuse exclusion criteria: * pregnancy or breastfeeding. * any clinically relevant abnormalities in physical examinations, vital signs, ecg, clinical chemistry, hematology or urinalysis * positive test for human immunodeficiency virus, hepatitis b or hepatitis c or known history of hiv infection