Kornimate/medical-research-clean huggingface dataset:
assess efficacy and safety of tachocomb h vs. standard surgical treatment (i.e. suturing) in patients undergoing prostatectomy (tc-017-au)

Conditions: Control of Local Bleeding in Patients Undergoing Prostatectomy.

Summary: the overall objective is to compare efficacy and safety of tachocomb h versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.


Eligibility criteria:
inclusion criteria: 1. has the subject given informed consent according to local requirements before any trial related activies? a trial related activity is any procedure that would not have been performed during the routine management of the subject. 2. is the subject 18 years of age or above ? 3. is the subject planned for a radical prostatectomy for prostate cancer (ct3)? after prostate resection and primary haemostatic treatment 4. is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)? exclusion: at pre-operative screen 1. is there anamnestic or laboratory evidence of coagulation disorders including haemophilia a or b and von willebrand disease ? 2. has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin? 3. is the patient undergoing an emergency operation? 4. did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial? 5. does the patient participate in a clinical trial concomitantly with present trial? after tumour resection and primary haemostatic treatment 6. has any serious surgical complication occurred? 7. has any fibrin glue haemostatic (including any type of tachocomb) been used before randomisation?
survey to identify substance use in teenagers and adolescents

Conditions: Anesthesia

Summary: this is a prospective survey study of patients 12-21 years undergoing anesthetic care. the primary objective is to determine the incidence of illicit substance use and abuse prior to anesthetic care. the secondary objective is to determine the illicit substances used and their frequency in patients presenting for anesthetic care.

the participants will be asked to complete a survey in redcap using an ipad during the visit. the study will record any positive answers from the drug and tobacco use questions routinely asked of the parents during the on-line pre-admission testing process. these include yes/no answers regarding drug, alcohol, and tobacco use. the information collected will include only demographic data including age, weight, gender, ethnicity/race, and zip code. survey data will be coded and will not include patient information. completion of the survey will take approximately 15-20 minutes.

Eligibility criteria:
inclusion criteria: * patients 12-21 years of age * presenting for surgery or procedure requiring anesthesia exclusion criteria: * patients who are not able to complete the computerized survey due to physical or intellectual impairment * patients who are non-english speaking
inspiratory muscle training in acute decompensated heart failure

Conditions: Acute Decompensated Heart Failure

Summary: hospitalized patients with acute decompensated heart failure (adhf) present a high prevalence of inspiratory muscle weakness on admission and discharge. inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. however, the effects of inspiratory muscle training in hospitalized patients with adhf have been not known. the aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with adhf.

the participants will randomly be allocated into two groups: (1) physical training plus inspiratory muscle training, (2) physical training participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. inspiratory muscle training will be applied with an electronic device. physical training will be implemented as balance, mobility, functional strength, endurance exercises. during the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. the physical training group will perform only physical training. physical training will be implemented as balance, mobility, functional strength, endurance exercises. during the hospitalization, physical training will be carried out once a day. for the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. for effects of inspiratory muscle training, data will be collected at baseline and hospital discharge.

Eligibility criteria:
inclusion criteria: * the management of a diagnosis of adhf over 24 hours in a hospital setting * hemodynamic stability * the independence of basic activities of daily life before admission exclusion criteria: * acute myocardial infarction * congenital heart disease * endocarditis, miyocarditis or pericarditis * morbid obesity * already participating in cardiac rehabilitation
evaluation of the effect of repeated usage on the tear film characteristics of an investigational eye drop in dry eye sufferers

Conditions: Dry Eye Syndrome

Summary: the main objectives of the investigation will be to assess the effect of the repeated usage of an investigational eye drop on the tear film characteristics of dry eye sufferers and demonstrate the benefit of this eye drops for dry eye sufferers.


Eligibility criteria:
inclusion criteria: * mild or greater dry eye symptoms. * evidence of evaporative dry eye exclusion criteria: * known allergy or sensitivity to the study product(s) or its components * current contact lens wearer * systemic or ocular allergies * use of systemic medication which might have ocular side effects. * any ocular infection. * use of ocular medication.
plasma exchange for renal vasculitis

Conditions: Wegener's Granulomatosis; Microscopic Polyangiitis

Summary: the purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.

primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (anca), is the most frequent cause of rapidly progressive glomerulonephritis. renal failure at presentation often progresses to end stage renal disease despite immunosuppressive therapy. we investigated whether the addition of plasma exchange was more effective than intravenous (iv) methyl prednisolone in the achievement of renal recovery for anca associated systemic vasculitis presenting with a serum creatinine above 500umol/l (5.8mg/dl). 137 patients with a new diagnosis of anca associated systemic vasculitis, serum creatinine above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing glomerulonephritis were randomized to receive seven plasma exchanges or iv methyl prednisolone 1000mg/day for three days. both groups were treated with cyclophosphamide and oral prednisolone. the primary end-point was dialysis independence with a serum creatinine below 500umol/l (5.8mg/dl) at three months. secondary end-points included renal and patient survival at 12 months and severe adverse event rates.

Eligibility criteria:
inclusion criteria: * diagnosis of wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by euvas from the disease definitions of the chapel hill consensus conference * biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy * severe renal impairment defined by: (i) oliguria (\ 500umol/l (5.8mg/dl). exclusion criteria: * age under 18 or over 80 years * inadequate contraception in women of child-bearing age * pregnancy * previous malignancy * hepatitis b antigenaemia, anti-hepatitis c virus or anti-human immunodeficiency virus antibody * diagnosis of churg-strauss syndrome, henoch-schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus * circulating anti-gbm antibodies or linear igg staining of the gbm on renal biopsy * life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission * on dialysis for \> two weeks prior to entry * creatinine \> 200umol/l (2.3mg/dl) one year or more before entry * a second clearly defined cause of renal failure * previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis * \> two weeks treatment with cyclophosphamide or azathioprine * \> 500mg iv methyl prednisolone * plasma exchange within the preceding year * \> three months treatment with oral prednisolone * allergy to study medications.

Keywords: vasculitis anca therapy plasma exchange immunosuppression
medical self-management for improving health behavior among individuals in community mental health settings

Conditions: Chronic Disease; Mental Illness

Summary: this study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.

people with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. this type of intervention, however, has yet to be systematically tested in individuals with mental disorders. community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. this study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center. participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.

Eligibility criteria:
inclusion criteria: * currently receiving treatment at dekalb community service board * chronic disease exclusion criteria: * history of more than two psychiatric or medical hospitalizations within the year prior to study entry

Keywords: peer-led education
cell-free dna: a non-invasive test for assessing embryo quality

Conditions: Culture Media; DNA

Summary: in the present project we propose to deeply characterize nuclear and/or mitochondrial dna in embryo culture medium, in order to investigate whether both cell-free nucleic acid types may provide additional, reliable, predictive parameters for embryo viability and implantation potential.


Eligibility criteria:
inclusion criteria: * we will enroll in the study only embryos obtained from fresh gametes. it is to note that we currently transfer more than one embryo (with a maximum of 3, according to patient's age) and we will follow such criteria alongside the project. consequently, we will take into consideration this aspect in correlating dna parameters with embryo's outcome. exclusion criteria: * we will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.

Keywords: human embryo culture media cell-free dna in vitro fertilization infertility
retrospective study on epidemiology of colorectal lesions

Conditions: ColoRectal Cancer; Colonic Polyp; Colonic Neoplasms

Summary: retrospective analysis on colonoscopies in the endoscopy unit of the lyell mcewin hospital.

colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.

Eligibility criteria:
inclusion criteria: * colonoscopies performed in lyell mcewin hospital between 2010-2016 exclusion criteria: * sigmoidoscopies

Keywords: polyps
studies of the ocular complications of aids (soca)--foscarnet-ganciclovir cmv retinitis trial (fgcrt)

Conditions: HIV Infections; Cytomegalovirus Retinitis

Summary: to evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (cmv) retinitis.

cmv retinitis is the most common intraocular infection in patients with aids and is estimated to affect 35 to 40 percent of patients with aids. untreated cmv retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. the first two drugs approved by the united states food and drug administration (fda) for the treatment of cmv retinitis were ganciclovir (cytovene) and foscarnet (foscavir). at the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). the fgcrt compared foscarnet and ganciclovir as initial therapy for cmv retinitis. the fgcrt was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for cmv retinitis. patients with previously untreated cmv retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. the outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.

Eligibility criteria:
inclusion criteria: * cmv retinitis in one or both eyes * at least 1/4 disk are of one cmv lesion photographable * diagnosis of aids as defined by center for disease control criteria or documented hiv infection * age 13 and greater * visual acuity ≥ 3/200 in at least one eye diagnosed with cmv retinitis * absolute neutrophil count ≥ 1,000 cells/µl * platelet ≥ 25,000 cells/µl * serum creatinine ≥ 2.0 mg/dl * karnofsky score ≥ 60 * informed consent exclusion criteria: * previous treatment of cmv retinitis * treatment with anti-cmv therapy for an extra-ocular cmv infection currently or in the past 28 days * known or suspected allergy to study drugs * pregnant or lactating
the effects of mirabegron and tadalafil on glucose tolerance in prediabetics

Conditions: Pre-diabetes; Obesity

Summary: the investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. the investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.


Eligibility criteria:
inclusion criteria: * hemoglobin a1c between 5.7 and 6.4 * body mass index between 27 and 45 exclusion criteria: * diabetes * chronic use of any antidiabetic medications * any unstable medical condition * use of steroids or daily use of nsaids * history of chronic inflammatory conditions * use of anticoagulants * contraindications to the use of mirabegron or tadalafil * any condition deemed risky by the study physician

Keywords: tadalafil mirabegron
viral & host factors associated with hepatitis b virus-related hepatocellular carcinoma

Conditions: Liver Cancer; Hepatitis B; Hepatitis C; Hepatobiliary Cancers Liver; Hepatobiliary Cancers

Summary: adult liver cancer is the third leading cause of cancer deaths worldwide. the major risk factor for liver cancer is hepatitis b virus (hbv) infection. the purpose of the study is to sequence the hbv genome in patients with chronic hbv infection, and in patients with liver cancer resulting from chronic hbv infection. the goal is to identify mutations in the hbv genome that predisposes these high risk individuals to the development of liver cancer.


Eligibility criteria:
inclusion criteria:1. patients diagnosed with liver cancer based on biopsy or serum afp level, associated with characteristic hypervascular liver tumors on triphasic spiral ct scan or mri. 2. patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. 3. patients with hepatitis b or hepatitis c viral infections not associated with liver cancer. exclusion criteria:no other patients except those listed above will be recruited. additionally, patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.
breast cancer screening: digital breast tomosynthesis versus digital 2d mammography

Conditions: Breast Cancer Screening

Summary: this study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2d mammograms (dbt+s2d) versus standard 2d full-field digital mammography (2d-ffdm) regarding the effectiveness as screening modality.

the primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2d mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2d full-field digital mammography in routine screening according to the european guidelines. furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis. according to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. the revised sample size calculation was carried out without knowledge of the data from the currently recruiting tosyma study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.

Eligibility criteria:
inclusion criteria: * women eligible to participate in the national mammography screening program of germany * informed decision for mammography screening * written informed consent * no prior participation in the tosyma trial exclusion criteria: * breast cancer up to 5 years prior to study invitation * previous mammography examination \< 12 months, * breast implants

Keywords: breast cancer population-based screening digital breast tomosynthesis plus synthesized mammography reconstructed mammography full-field digital mammography (ffdm) multicentric randomized controlled trial diagnostic performance recall rate interval cancer
neurofibromatosis type 1 brain tumor genetic risk

Conditions: Neurofibromatosis Type 1; Pediatric Brain Tumor

Summary: this study will analyze dna samples to determine associations between maternal and offspring genetic factors and pediatric brain tumor development in children with neurofibromatosis type 1. participating families (mother, father, child) will be asked to complete a short questionnaire and provide dna samples (either saliva or blood). the information gained from your participation may one day help doctors develop strategies to reduce brain tumor risk in individuals with nf1. please note: there is no therapy associated with this study.

the prenatal period is a developmentally vulnerable time point during which environmental conditions, including nutrition, can have life-long impacts on health.1,2 this is particularly relevant to many childhood cancers that are thought to initiate during pregnancy.3 as a consequence, there has been intense interest in whether prenatal exposures can modulate childhood cancer risk.4-6 it is important to recognize that both maternal and offspring genetic factors including those in nutritional pathways may play an important role in pediatric cancer risk through their effect on the child's exposure to nutrients important in development during the prenatal period. the purpose of this research study is to evaluate whether there are any maternal or offspring genetic factors in the folate pathway that may contribute to the development of brain tumors in children with neurofibromatosis type 1 through analysis of dna samples collected from families.

Eligibility criteria:
inclusion criteria: * pediatric participant (born during 1994-2012) with nf1 and diagnosed with a brain tumor * biological mother or father (or full sibling if mother or father is unable to participate) able to participate * all family members (pediatric participant, biological mother, and biological father or full sibling) must be willing to contribute a blood or saliva sample * ability to understand consent forms exclusion criteria: -those who do not meet inclusion criteria