Kornimate/medical-research-clean huggingface dataset:
trial of drainage with or without bleomycin instillation for malignant pericardial effusion

Conditions: Malignant Pericardial Effusion

Summary: the purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.

malignant pericardial effusions (mpes), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. in lung cancer patients, mpe is one of the most unpleasant terminal events. drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. there is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for mpes, and it is far from clear whether sclerosis really benefits these patients in terminal stages. comparison: intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for mpes caused by lung cancer.

Eligibility criteria:
inclusion criteria: * pathologically documented lung cancer * clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology) * expected to live 6 weeks or longer * sufficient organ function * signed informed consent exclusion criteria: * myocardial infarction or unstable angina within 3 months * constrictive pericarditis * active pneumonitis * severe infection or disseminated intravascular coagulation (dic) * other severe co-morbidity which could not be relieved with pericardial drainage * chemotherapy-naive small cell lung cancer

Keywords: pulmonary neoplasm malignant pericardial effusion pericardial drainage randomized trial bleomycin intrapericardial instillation
creation of a small cavity reduces the rate of cement leakage during vertebral body augmentation

Conditions: Vertebral Body Fracture

Summary: leakage of polymethylmethacrylate (pmma) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. any measure to reduce the rate of cement leakage is of value and makes the procedure safer.the aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.


Eligibility criteria:
inclusion criteria: * osteoporotic vertebral body fractures of the thoracolumbar spine (t9 to l4) that were classified as a1 fractures according to arbeitsgemeinschaft osteosynthesis (ao) classification exclusion criteria: * more than 2 vertebral body fractures * fractures of vertebral body based on malignancy * previous spinal operation * spinal infection * spinal deformity (scoliosis)

Keywords: cement leakage cement augmentation vertebral body fracture vertebral cavity vertebroplasty
a double blind study comparing hyaluronic acid, corticosteroid and placebo during arthrocentesis for temporomandibular joint (tmj) dysfunction

Conditions: Temporomandibular Joint Dysfunction; Pain; Arthrocentesis

Summary: the purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. the overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (vas) at one month when compared to celestone and placebo.

this study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. at the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. subjects will be followed for 3 months. those who do not show improvement may be candidates for additional treatment.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * arthralgia of one or both temporomandibular joints * wilkes ii to iv internal derangement of the symptomatic joint or * limited opening of \<35 mm exclusion criteria: * myofascial pain as the primary source of pain * cervical pain as the primary source of pain * systemic arthropathy * fibromyalgia * use of nsaids within 48 hours * allergy to study medications * edentulous subjects * pregnancy or breast feeding * current physical therapy, muscle relaxants or antiseizure medications * current use of a splint issued within last 12 weeks
implementation of practice standards for ecg monitoring

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to test the effect of implementing new practice standards for electrocardiographic (ecg) monitoring on nurses' knowledge and skills, quality of care, and patient outcomes. the investigators hypothesize that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients.

despite advances in hospital electrocardiographic (ecg) monitoring technology, monitoring practices are inconsistent and often inadequate. the investigators recently published practice standards for ecg monitoring. the primary purpose of this 5-year multisite randomized clinical trial is to test the effect of implementing these standards on nurses' knowledge and skills, quality of care, and patient outcomes. the investigators expect that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients. units serving cardiac patients in 17 hospitals will participate. hospitals will be randomized to the experimental or control group after baseline measures of knowledge and skills, quality of care, and patient outcomes are obtained. the intervention will include ecg monitoring education and strategies to implement and sustain change. the online education will include 4 modules: essentials of ecg monitoring, arrhythmia monitoring, ischemia monitoring, and qt interval monitoring. the strategies to implement and sustain change in the clinical area include reinforcement of education, incentives, and the designation of "champions" on each unit who will actively promote the implementation of the practice standards.

Eligibility criteria:
inclusion criteria: * nurses (and monitor technicians): all nurses (and monitor technicians) working on participating units serving patients with cardiac disease * patients: all patients cared for on participating units exclusion criteria: * nurses (and monitor technicians): no nurses (or monitor technicians) will be excluded * patients: no patients on the participating units will be excluded, even if their primary diagnosis is not cardiac

Keywords: electrocardiographic monitoring arrhythmia myocardial ischemia
distribution of human papillomavirus (hpv) genotypes in patients with cervical cancer from croatia

Conditions: Cervical Cancer

Summary: human papillomavirus (hpv) of high-risk genotype is a necessary risk factor in development of cervical cancer. there is a vaccine available to prevent cervical lesions associated with high-risk hpv genotypes 16 and 18. in croatia hpv vaccination has not yet been introduced in obligatory vaccination schedule. the aim of this study is to describe the pre-vaccination distribution of hpv genotypes in women with high grade cervical squamous intraepithelial lesion (hsil) and cervical cancer in croatia. the investigators hypothesis is that hpv-16 is the most frequently found genotype but the distribution of other hpv genotypes is heterogeneous and includes genotypes currently not covered by vaccination.

this is a single-center cross-sectional study on the molecular virology of human papillomavirus (hpv) in croatia. the study will enroll women aged 18-65 years of age with cervical intraepithelial neoplasia (cin2+)cervical lesions that received clinical care at the croatian center for pre-malignant and malignant diseases of the cervix. women with abnormal cytology (high grade cervical squamous intraepithelial lesion-hsil, cervical cancer) in the period from 2010 to 2012 will be included. relevant epidemiological and clinical data will be collected. biological samples will include both biopsy specimens from cervix and cervical swab. biological samples will be put in digene specimen transport medium (qiagen, gaithersburg, md) and further analyzed at the department of molecular diagnostics at the university hospital for infectious diseases in zagreb. hpv genotyping will be performed by using a standardized molecular assay inno-lipa hpv genotyping extra test (solvay s.a., brussels, belgium). analysis of genomic variants of hpv 16 genotype will be performed by population-based sequencing of l1 genome region.

Eligibility criteria:
inclusion criteria: * women aged 18-65 with a cytological diagnosis of cin2+cervical lesions from all over croatia that are referred to national reference center because of hsil or malignant cytology findings exclusion criteria: * women younger than 18 or older than 65 * pregnant women

Keywords: human papillomavirus (hpv) cervical cancer high grade cervical squamous intraepithelial lesion (hsil)
biomagnetic signals of intestinal ischemia ii

Conditions: Ischemia

Summary: the lack of blood flow to the small intestine causes mesenteric ischemia. using a superconducting quantum interference device (squid) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

the electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. the major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. mesenteric ischemia is caused by the lack of blood flow to the intestine. the superconducting quantum interference device (squid) measures the magnetic field of the intestinal smooth muscle. by comparing normal smooth muscle and that of patients with mesenteric ischemia, the investigators hope to identify abnormal disease states without surgery.

Eligibility criteria:
inclusion criteria: * normal subjects and those with diagnosed mesenteric ischemia exclusion criteria: * subjects who report a tendency toward claustrophobia

Keywords: blood supply mesentery
importance in type 1 diabetes patients of an optimized control of post-prandial glycaemia on oxidant stress prevention

Conditions: Type 1 Diabetes

Summary: the aim of this study is to determine whether postprandial hyperglycaemia plays an important role in oxidative stress phenomena and influences their harmful effects on the arterial wall. 25 type 1 diabetic patients practicing fit and with an hba1c value of 8 percent or less at the beginning of the study will be recruited. the 25 control subjects will be recruited after the patients, so that they can be paired by age and sex. patients will be randomized via an alternative cross over study design for 2 periods of 3 months, i.e. preprandial or postprandial injection of an ultra fast acting analog. during the 6 months of the study, slow acting analog doses will be adjusted on the basis of basal glycaemia values. the fast acting analog doses will be adjusted on the basis of an optimized algorithm available on each patient's pda phone electronic diary. blood and urine samples will be collected at m0, m3 and m6 to evaluate the stress oxidant grade and its consequence on atherogenesis: oxidative stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and oxidised glutathion, dismutase superoxide activity (sod) cu and mn dependent, glutathion peroxidase, and catalase), urinary parameters (isoprostane f2) evaluation of consequences of oxidative stress on atherogenesis processes: inflammatory parameters (crp, tnfa, il 6), adhesion molecules (vcam 1, icam 1, p selectine), adipokines (leptine, resistine, adiponectine), coagulation factors (pai 1), platelet and endothelial microparticles, the pre and postprandial glycaemic stability of each patient will be monitored using pda phone systems, and hba1c will be measured at m0, m3 and m6. expected results and outcomes: it is important to know if, in patients with comparable glycaemic stability, these two insulin treatment regimens are associated with significant differences in oxidative stress and anti oxidant defenses. these results may help us to define a postprandial insulin treatment regimen (which is more flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).


Eligibility criteria:
inclusion criteria: * type 1 diabetes * treaties by basal / bolus with a ultra rapid analogue or a pump with a ultra rapid analogue * adults between 18 and 50 years old * patients practicing fit * written informed consent obtained prior to enrollment in the study * hba1c ≤ 8% exclusion criteria: * diabetes other than dt1 * complications: coronary or peripheral arteriopathy * pathologies being able to interfere with the study: hta, dyslipidemia, nicotinism, inflammatory , cancerous pathology... * psychiatric pathologies incompatible with the study * pregnancy
rab versus ultrathin bronchoscopy with vbn in the diagnosis of ppns

Conditions: Peripheral Pulmonary Nodules

Summary: the purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.

this is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 184 participants planned for enrollment. subjects with peripheral pulmonary nodules (ppns) suspected of malignancy, requiring non-surgical biopsy detected by chest ct will be included in this study. firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. the experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by changzhou langhe medical devices co., ltd. for the localization and sampling of ppns. the control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. radial endobronchial ultrasound (r-ebus) will be available for all procedures. if the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. the primary endpoint is the diagnostic yield. secondary endpoints include navigation success yield, arrival time, and incidence of complications.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, regardless of gender; 2. patients with peripheral lung nodules of suspected malignancy on chest ct who require non-surgical biopsy; 3. patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy; 4. patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form. exclusion criteria: 1. presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/l), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion; 2. patients with pure ground-glass nodules suspected of malignancy on chest ct; 3. female patients who are breastfeeding, pregnant, or planning pregnancy; 4. patients with electromagnetic active implantable medical devices; 5. subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history; 6. those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days; 7. any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
influence of position on detection of patent foramen ovale by simultaneous transesophageal echo and transcranial doppler

Conditions: Patent Foramen Ovale

Summary: patients will have simultaneous transesophageal echo (tee) and transcranial doppler (tcd) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.


Eligibility criteria:
inclusion criteria: * patients needing a tee evaluation to rule out a cardiac source of brain emboli exclusion criteria: * patients unable to comply with protocol requirements * patients unable or unwilling to sign informed consent

Keywords: patent foramen ovale
anticipatory muscle control and effect of stabilizing exercises in patients with subacute and chronic low back pain

Conditions: Low Back Pain

Summary: muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. sudden postural disturbances impose reactive internal forces through the spine. if the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. the purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.


Eligibility criteria:
inclusion criteria: * unspecific subacute, subacute remitting and chronic lbp * both sexes, 20-60 yrs of age * lbp between 2-8 on a 11-pt numeric rating scale exclusion criteria: * previous back surgery * sick listed more than one year * radiating pain below knee or motor deficits * systemic diseases and "red flags" * diagnosed psychiatric disease * ingoing insurance claim * pregnancy

Keywords: muscle, skeletal neuromuscular control stability exercise anticipatory muscle control
simo decoction and gum chewing for bowel activity

Conditions: Hepatocellular Carcinoma

Summary: abdominal surgery, including hepatic resection for hepatocellular carcinoma (hcc), is inevitably followed by an episode of gastrointestinal hypomotility. a delayed return of gastrointestinal function, defined as postoperative ileus (poi), has a great impact on patient comfort, morbidity and recovery. poi often results in a prolonged hospital stay and contributes significantly to healthcare costs. some prospective studies have revealed that gum chewing can improve the return of gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary system surgery. moreover, some retrospective studies also revealed that simo decoction may improve the return of gastrointestinal function after hepatic resection of hcc. therefore, the present study compared the effect of gum chewing and simo decoction after hepatic resection of hcc on poi, surgical complications, and length of hospital stay.


Eligibility criteria:
inclusion criteria: * underwent open hepatic resection * diagnosis of hcc was confirmed by histopathological examination of surgical samples in all patients exclusion criteria: * previously underwent exploratory laparotomy * laparoscopic surgery * known central nervous system tumors including metastatic brain disease * history of organ allograft * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study * pregnant or breast-feeding patients
temozolomide for relapsed sensitive or refractory small cell lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma. as part of this study, we will be doing additional tests that may help us understand how temozolomide works. first, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. also, before starting temozolomide and every time you have a repeat ct scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.


Eligibility criteria:
inclusion criteria: * patients must have pathologically confirmed sclc at mskcc that has progressed after one or two chemotherapy regimens. * at least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment. * karnofsky performance status \> or = to 60%. * patients must have measurable disease, this can include brain metastases. * patients must have normal organ and marrow function as defined below: * - leukocytes \> 3,000/mcl * platelets \> 100,000/mcl * total bilirubin \< 1.5 mg/dl * ast(sgot)/alt(sgpt) \< 2.5 x institutional upper limit of normal * creatinine \< 2.0 mg/dl * for women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide. * men and women of childbearing potential must agree to practice adequate contraception. * ability to understand and the willingness to sign a written informed consent document. * both men and women of all races and ethnic groups are eligible for this trial. exclusion criteria: * patients who have not recovered from adverse events of previous therapies. * patients receiving other investigational agents. * patients with leptomeningeal involvement. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. * acquired immune deficiency syndrome (aids) based upon current cdc definition or hiv-positive patients on combination antiretroviral therapy. however, hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. excluding patients on haart is necessary due to the potential for pharmacokinetic interactions with temozolomide. * women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.

Keywords: temozolomide lung