Kornimate/medical-research-clean huggingface dataset:
bleeding in laparoscopic liver surgery

Conditions: Neuromuscular Blockade; Intraoperative Bleeding; Hepatic Cancer

Summary: blood loss during liver resection surgery affects patients morbidity, short and long-term mortality. among non-surgical interventions to minimize intraoperative blood loss and perioperative blood products transfusion, maintaining conditions of low central venous pressure is considered as standard of care. in animals undergoing laparoscopic hepatectomy, reducing airway pressures represents a minimally invasive measure to reduce central venous pressure and therefore bleeding from the hepatic vein. neuromuscular blocking agents are usually administered during anesthesia to facilitate endotracheal intubation and to improve surgical conditions: a deep level of neuromuscular blockade has already been shown to reduce peak airway pressures and plateau airway pressures in non-abdominal procedures. such airway pressures reduction can potentially limit bleeding from hepatic veins during transection phase in liver surgery. the aim of the present study is to evaluate the impact of deep neuromuscular blockade on bleeding (as a consequence of reduced airway peak pressure and plateau pressure) in hepatic laparoscopic resections. patients undergoing laparoscopic liver resection will be randomized to achieve, using intravenous rocuronium, either a deep neuromuscular blockade (post-tetanic count = 0 and/or = 1 and train of four count = 0) or moderate neuromuscular blockade (train of four count ≥ 1 and/or post-tetanic count \> 5) during surgery. neuromuscular blockade measurements will be performed every 15 minutes. the primary endpoint is to assess the total blood loss at the end of the resection phase.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic liver resection * patients ≥ 18 years old * patients willing to participate to the study and able to validly sign informed consent. exclusion criteria: * patients presenting a pre-operative platelet count \< 50 x 109/l and/or patients with active pre-operative bleeding * patients with planned requirement of continuous neuromuscular blockade monitoring (upon clinical judgement) * known hypersensitivity / previous allergic reactions to study medications * planned total intra-venous anesthesia technique * pregnant or breastfeeding patients.

Keywords: liver surgery bleeding neuromuscular blockade rocuronium airway pressure
efficacy and safety of qinbudan as an adjunct therapy for retreatment pulmonary tuberculosis

Conditions: Pulmonary Tuberculosis

Summary: the purpose of this study is to assess the efficacy and safety of chinese medicine qinbudan in patients receiving standard combination therapy for retreatment pulmonary tuberculosis.

retreatment of tuberculosis involves the management of entities as diverse as relapse, failure, treatment after default, and poor patient adherence to the previous treatment. the emergence of conditions for selection of resistance (failure and partial abandonment) is a matter of great concern. the current chemotherapy is the primary interventions, but the long-term drug combination therapy often leads to adverse reactions. the purpose of this study that is to exploring the role of chinese medicine qinbudan on patients who are initially sputum smear positive or culture-positive who have been treated previously for pulmonary tuberculosis.

Eligibility criteria:
inclusion criteria: * patients who are initially sputum smear positive (at least two smears as "1+" or at least have a smear as "2+" and above) or culture-positive for pulmonary tuberculosis who have been treated previously * aged 18 -65 years of age * patients who are willing to give written informed consent exclusion criteria: * participation in another clinical trial 1 month prior to study entry * female patients in lactation period, pregnancy or planning to get pregnant during the trial * patients who are allergic to the therapeutic medicine * patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases * patients co-infected with hiv, hepatitis b or hepatitis c * patients with mental illness, acrasia * abnormal liver function or combined with other underlying liver disease (fatty liver, alcoholic liver) * patients with diabetes, plasma glucose poorly controlled undertaking * patients with auditory dysfunction

Keywords: retreatment pulmonary tuberculosis, qinbudan,
the use of different types of mesh for prevention of incisional hernia versus primary abdominal suturing

Conditions: Incisional Hernia

Summary: the use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.

the burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit. the reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. the impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure. one of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases. since german physician theodor billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . overtime, rcts have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. while surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (pmr) such as the onlay, sublay and intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.

Eligibility criteria:
inclusion criteria: * informed consent * patient age: ≥ 18 years * patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease exclusion criteria: * age \<18 years * navel site infection * pregnancy * expected survival \<12 month * previous intra abdominal mesh placement
genetic counseling in african american women

Conditions: Breast Cancer; Ovarian Cancer

Summary: the objectives of this study are to develop a culturally tailored genetic (ctgc) protocol for african american women and evaluate its impact on decision making and satisfaction about brca1/2 testing, quality of life, and cancer control practices compared to standard genetic counseling (sgc). a secondary objective of this study is to identify african american women who are most and least likely to benefit from ctgc vs. sgc.

five to 10% of all breast cancer cases have been attributed to two breast ovarian cancer susceptibility genes called brca1 and brca2 (brca1/2). genetic counseling and testing for brca1/2 mutations is now available through clinical research programs using standard counseling protocols. the goal of pre test counseling is to facilitate informed decision making about whether to be tested and to prepare participants for possible outcomes. the goal of post test counseling is to provide information about risk status, recommendations for surveillance, and options for prevention. however, previous research suggests that african american and caucasian women differ in their attitudes about and responses to pre test education and counseling. increasingly, cultural beliefs and values are being recognized as important factors in genetic counseling. despite recommendations to increase the cultural sensitivity of breast cancer risk counseling, such programs have not been developed or evaluated. therefore, the purpose of this study is to develop a culturally tailored genetic counseling (ctgc) protocol for african american women and evaluate its impact on psychological functioning and health behaviors compared with standard genetic counseling (sgc) in a randomized clinical trial. 1. to evaluate the relative impact of ctgc vs. sgc on decision making and satisfaction about brca1/2 testing. compared to sgc, ctgc will lead to higher rates of test acceptance and satisfaction with testing decisions. these effects will be mediated by increases in perceived benefits and decreases in perceived limitations and risks of genetic testing. 2. to evaluate the impact of ctgc vs. sgc on quality of life and health behaviors following brca1/2 testing. compared to sgc, ctgc will lead to larger decreases in general and cancer specific distress, greater increases in adherence to cancer screening guidelines, and lower rates of prophylactic surgery. reductions in psychological distress will be mediated by increased use of spiritual coping strategies. secondary aim to identify african american women who are most and least likely to benefit from ctgc vs. sgc. we predict that the relative benefits of ctgc will be greatest for women with greater endorsement of african american cultural values and those identified as brca1/2 carriers.

Eligibility criteria:
inclusion criteria: * female * african american or black * 5% to 10% prior probability of having a brca1 or brca2 mutation exclusion criteria: * men * individuals who are not african american or black

Keywords: genetic counseling brca1 and brca2 african american
a study of oral mbq-167 in participants with advanced breast cancer

Conditions: Breast Cancer; Breast Neoplasm; Breast Cancer Stage IV

Summary: a phase 1, open-label, dose-escalation clinical trial of mbq-167 in participants with advanced breast cancer for whom standard of care (soc) has failed or has proven intolerable.

the main questions this clinical trial aims to answer are: * what, if any, are the side effects of different dose levels in humans? * what is the maximum tolerated dose? * how does the human body process the drug? * does the drug slow, stop or eliminate cancer in human participants? participants will be asked to: * provide informed consent * be evaluated by physicians and provide laboratory specimens to determine if eligible * take mbq-167 orally twice a day for at least 21 days * may continue dosing, if safe to do so, until not effective or other decision to stop is made * participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug

Eligibility criteria:
key inclusion criteria: * the investigator will evaluate these and other criteria to determine whether a participant can be included in this study. * histologically and/or cytologically confirmed advanced breast cancer which has progressed after treatment with approved therapies or for which there are no standard therapies available. * participants with known brain metastases may be eligible if specific conditions are met. * life expectancy ≥6 months, in the opinion of the investigator, after starting mbq-167. * are able to swallow capsules twice daily with a meal. key exclusion criteria: * the investigator will evaluate these and other criteria to determine whether a participant should be excluded from this study. * inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of mbq-167. * females who are pregnant or breastfeeding. * participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than grade 0 or 1 related to previous anticancer treatment. * participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than grade 0 or 1 related to previous anticancer treatment. * active malignancies other than advanced breast cancer will be excluded from the study.

Keywords: advanced breast cancer metastatic breast cancer recurrent breast cancer
the effect of frequent continuous glucose monitoring use on glucose variability in preschoolers with type 1 diabetes

Conditions: Type 1 Diabetes; Continuous Glucose Monitoring; Children; Glucose Variability

Summary: the purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with t1d. the study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting cgm use to smbg alone in young children with type 1 diabetes over 12 months. the primary endpoint is the difference between treatment modalities (cgm vs smbg alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. other key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.


Eligibility criteria:
key inclusion criteria: 1. age below 7 years of age (at inclusion) 2. type 1 diabetes for at least 6 months 3. insulin pump user for at least 3 months 4. treated with rapid or ultra-rapid acting insulin analogue key exclusion criteria: 1. physical or psychological disease likely to interfere with normal conduct of the study 2. untreated coeliac disease or thyroid disease 3. current treatment with drugs known to interfere with glucose metabolism 4. subject/carer's severe visual impairment 5. subject/carer's severe hearing impairment
b'more healthy; communities for kids (bhck)

Conditions: Obesity

Summary: the bhck study will develop, implement, and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in baltimore, md), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income, minority neighborhoods.

our overarching goal is to develop and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in baltimore, md), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income minority neighborhoods. our research will include stakeholders/ partners at different levels, e.g., the policy, wholesaler, retailer, adult caregiver, and individual child levels, and then develop, implement, and assess a two year multi-level systems-based child obesity prevention strategy targeting minority and low-income children (predominantly aa). thirty low-income, predominantly aa geographic zones will be identified ("healthy eating zones"). half of these zones will be randomized to intervention, while the other half will be control. within each intervention zone we will work with 3-5 small food stores and prepared food sources to increase access to healthy foods through wholesaler discounts, display point of purchase promotional materials, and provide nutrition and food preparation education targeting youth and caregivers. we will work with local policymakers to institutionalize and sustain these changes. the project will evaluate the impact of the program on: a) healthy food pricing and availability, b) low income african american adult food purchasing and preparation, and c) low-income african american youth diet, and associated psychosocial factors.

Eligibility criteria:
inclusion criteria for child participants: 9-14 years of age living within one of the intervention neighborhoods family does not anticipate moving outside of the study area during the duration of intervention inclusion criteria for adult caregiver participants: parent/ legal guardian of a child ages 9-14 years of age living within one of the intervention neighborhoods family does not anticipate moving outside of the study area during the duration of intervention exclusion criteria: families that do not have a child within the age range families that do not live within the neighborhoods in the study area families who will move outside the study area within the intervention timeframe

Keywords: african american adolescents urban food desert food insecurity obesity baltimore city peer mentors multi level policy caregivers systems agent based model systems dynamic model corner store carryout recreation center text messaging social media mapping
the alirocumab for stopping atherosclerosis progression in saphenous vein grafts (asap-svg) pilot trial

Conditions: Saphenous Vein Graft Atherosclerosis

Summary: this is a phase iv, multi-center, double-blind, randomized, placebo- controlled study evaluating the effect of alirocumab on svg atherosclerotic disease burden, as assessed by ivus at baseline and following 78 weeks of treatment in subjects with at least one intermediate svg lesion receiving optimal statin therapy. subjects will be randomized 1:1 into 2 treatment groups: alirocumab 150 mg subcutaneously every 2 weeks or placebo subcutaneously every 2 weeks.


Eligibility criteria:
inclusion criteria: 1. age 18 years or greater. 2. willing and able to give informed consent. the patients must be able to comply with study procedures and follow-up. 3. undergoing clinically-indicated coronary and svg angiography. 4. have at least one target saphenous vein graft with an intermediate svg lesion (defined as a lesion with 30-60% angiographic diameter stenosis) amenable to examination with ivus. the svg should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for angiography. 5. receiving optimal statin therapy defined as use of a high intensity statin (atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily), any statin therapy with achieved ldl-c level \<70mg/dl, or maximally-tolerated statin dose for patients who are statin intolerant statin. exclusion criteria: 1. positive pregnancy test or breast-feeding. 2. coexisting conditions that limit life expectancy to less than 18 months or that could affect a patient's compliance with the protocol. 3. estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2. 4. severe peripheral arterial disease limiting vascular access. 5. history of allergic reaction to iodine-based contrast agents that cannot be premedicated. 6. known hypersensitivity to alirocumab. 7. any prior use of proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitor therapy.
4beta-hydroxycholesterol in cirrhosis

Conditions: Cirrhosis, Liver

Summary: the aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. also three other control cohorts are recruited: patients with pneumonia, patients with crohn's disease, patients with ulcerative colitis. the effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.


Eligibility criteria:
inclusion criteria: * patients with cirrhosis, pneumonia, crohn's disease or colitis ulcerosa * treated in the ward 42 of the oulu university hospital exclusion criteria: * none
mannose binding lectin gene polymorphism versus microbial virulence in the pathogenesis of vulvovaginal candidiasis

Conditions: Infection

Summary: the vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease

Eligibility criteria:
inclusion criteria: * 1. married females in the reproductive age period. 2. females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema. exclusion criteria: * females who attended the same clinic in the same period, matched the cases regarding the age group, without having candida infection as confirmed by culture of vaginal swabs.
combination chemotherapy in treating infants with newly diagnosed neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.

objectives: * confirm that the outcome for infants with newly diagnosed stage iv or ivs neuroblastoma without mycn amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide, doxorubicin, and vincristine. * determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients. * determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients. outline: this is a multicenter study. patients are stratified according to age (under 1 month vs over 1 month). infants less than 1 month of age are further stratified according to philadelphia score (less than 1 vs at least 1). infants over 1 month of age are also further stratified according to philadelphia score (less than 2 vs at least 2). infants under 1 month of age with philadelphia score of less than 1 and infants over 1 month of age with philadelphia score of less than 2 undergo observation only. infants under 1 month of age with philadelphia score of at least 1 and infants over 1 month of age with philadelphia score of at least 2 receive vp-carbo chemotherapy. * vp-carbo chemotherapy: patients receive etoposide iv over 2 hours and carboplatin iv over 1 hour on days 1-3. treatment repeats every 21 days for 2 courses. patients with no response receive cado chemotherapy. * cado chemotherapy: patients receive cyclophosphamide iv over 1 hour on days 1-5, doxorubicin iv over 6 hours on days 4 and 5, and vincristine iv on days 1 and 5. treatment repeats every 21 days for a maximum of 4 courses. patients are followed within 6 months and then annually for 5 years. projected accrual: a total of 130 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: * histologically confirmed newly diagnosed stage iv or ivs neuroblastoma or ganglioneuroblastoma * metastases confined to marrow, skin, nodes, or liver * no metastases to bone (radiologic bone lesions in skeleton), cns, pleura, or lung * no mycn amplification (i.e., fewer than 10 copies) patient characteristics: age: * under 12 months at diagnosis performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: disseminated neuroblastoma stage 4s neuroblastoma