Kornimate/medical-research-clean huggingface dataset:
internet-based cervical cytology screening program

Conditions: Cervical Cancer

Summary: the purpose of this study is to assess whether a system that couples automated screening of pap tests with transmission of machine selected digital images, and review by cytologists at a remote location, performs to a clinically effective standard of accuracy.

this clinical study uses the automated screening capabilities of the focalpoint primary screening system (bd) for gynecologic cytology specimens (pap tests) to allow for automated field of view (fov) selection, digital image capture, and subsequent internet-based transmission to a custom designed computer-based image reading station. the system utilizes liquid-based cytology preparations (thinprep, surepath). in such a system, no skilled cytology human resources are necessary at the scanning site, and all expertise can be centralized. pilot studies showed that the task was feasible to a clinically relevant standard of care. phase 1 trials on preselected and seeded specimens confirmed this clinical standard. the phase 2 trials extend the concept to a prospectively enrolled population of patients from 2 sites (walter reed, mass general) thereby testing the concept in a population of normal disease prevalence. the final phase 3 will be a larger study with intended use design, siting a screening device at the 121st army hospital in korea and interpreting the specimen images in the us. in addition to the reading of the specimens, the system is designed to give immediate "loop closing" results back to each specimen's originating point immediate upon completion of the test.

Eligibility criteria:
inclusion criteria: * female presenting to clinic for a pap test for any reason exclusion criteria: * pregnant * prisoners * mentally unable to provide informed consent

Keywords: cervical cancer, automation, internet, telecytology
surface nerve stimulation treatment for oab in children

Conditions: Overactive Bladder; Urinary Incontinence

Summary: the purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with oab.

daytime urinary incontinence is common in children. at the age of 7 a prevalence of 2-9 % has been reported. daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified. the symptom based diagnosis oab (overactive bladder) is most often used to describe daytime urinary incontinence in children. oab is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency. when urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment of oab. it is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. in the non-responding cases behavioural modifying regimes can be coupled with anticholinergic medication. however, poor compliance of the child or parents, or dose limiting side effects often influences the efficacy of this intervention. also a considerable number of children experience no or only limited effect from the treatment even though all instructions are complied with. this has let to research into new treatment modalities and the use of low frequency electrical current to inhibit detrusor overactivity in adults has become common. pilot studies have indicated a significant effect of tens on urinary incontinence in children with oab. hypothesis: * sacral tens is an effective treatment of urinary incontinence in children with oab refractory to anticholinergic medication coupled with bladder training and voiding reeducation. * the acute effect of sacral tens can be identified by urodynamics * it is possible to predict the outcome of sacral tens treatment in these children. 30 children (age 5-14 years) with functional daytime incontinence refractory to anticholinergic medication coupled with bladder training. the study protocol consists of 1 week of basic home registrations and a 4 day in-patient phase succeeded by a 4 week home training period. the participants will be randomized to treatment with either active or inactive tens.

Eligibility criteria:
inclusion criteria: * daytime urinary incontinence with at least 1 episode of at least 1 ml per week * incontinence refractory to treatment * informed consent exclusion criteria: * severe diseases of the kidneys or urinary tract besides oab

Keywords: overactive bladder children nerve stimulation tens
safety and efficacy of sitagliptin compared with glimepiride in elderly participants with type 2 diabetes mellitus (mk-0431-251)

Conditions: Type 2 Diabetes Mellitus

Summary: the primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin a1c (hba1c) after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of symptomatic hypoglycemia compared to that of glimepiride. the study will also evaluate if sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma glucose (fpg) levels, and plasma lipid levels after 30 weeks of treatment. participants will be randomized to either sitagliptin or glimepiride treatment after eligibility for study participation is determined during screening and washout study phases. participants and study staff will not know to which treatment group they have been randomized (double-blind design). the duration of study participation will be up to 40 weeks (with 9 clinic visits). this will include a screening phase (visit 1 to visit 2) of 2 weeks maximum; a 6-week (visits 2 to 3) oral antihyperglycemic agent (aha) wash-out phase (for those who have been taking a aha prior to the study); a placebo run-in phase (visits 3 to 4), followed by up to 30 weeks of treatment with study medication.

the dose of sitagliptin will be 100 mg once daily (qd) or 50 mg qd based on the participant's estimated glomerular filtration rate (egfr). the starting dose of glimepiride (1 mg qd) may be up-titrated as needed to optimize glycemic control over the first 18 weeks to a maximum dose of 6 mg/day, after which the dose will not be increased for the rest of the study (down-titration to avoid or control hypoglycemia is allowed).

Eligibility criteria:
inclusion criteria * diagnosis of type 2 diabetes mellitus exclusion criteria * history of type 1 diabetes mellitus * has undergone a surgical procedure within the prior 4 weeks. * current participation in, or has participated, in another study with an investigational device or compound, with the prior 12 weeks, and/or is not willing to refrain from participating in any other study while participating in this study * hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride) medication * has been on an investigational or approved dipeptidyl peptidase-4 (dpp-4) inhibitor agent (e.g., sitagliptin, saxagliptin) * presence of human immunodeficiency virus (hiv) * current participation in a weight loss program or is receiving weight loss medication * history of blood disorder, certain cancers, heart, liver or kidney disease * current or past use of recreational or illicit drugs, or a history of drug abuse or dependence, or increased alcohol consumption

Keywords: type 2 diabetes mellitus, hemoglobin a1c, glucagon-like peptide 1 (glp-1), gastric inhibitory polypeptide (gip), dipeptidyl peptidase 4 inhibitor (dpp-4)
caregivers' and physicians' treatment preference in parkinson patients treated with neupro® requiring caregiver support

Conditions: Idiopathic Parkinson's Disease

Summary: the study objective is to evaluate advantages and disadvantages of neupro® versus oral anti-parkinson medication by caregivers and physicians in idiopathic parkinson's disease patients requiring caregiver support in nursing home or outpatient care settings.


Eligibility criteria:
inclusion criteria: * only patients having signed the consent form regarding study information, data transfer and data use * the patients suffer from idiopathic parkinson's disease (ipd) treated with a combination of l-dopa or another oral ipd drug and neupro® for at least one month * the patients require caregiver support documented as per medical records (e.g. based on german level of care intensity 1 or greater) * the decision to prescribe neupro® must have been made by the physician independent of his/her decision to include the patient in the study exclusion criteria: * patients not fulfilling the inclusion criteria * and according to summary of product characteristics (smpc): hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (mrt) or cardioversion

Keywords: rotigotine neupro® parkinson treatment preference care-giving
how to identify fatigue in stroke patients

Conditions: Post Stroke Fatigue; Stroke

Summary: this study will translate an english case definition of poststroke fatigue and validate it against the multidimensional fatigue questionnaire-20 and the fatigue severity scale


Eligibility criteria:
inclusion criteria: patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant. patients that have given written informed consent - exclusion criteria: patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -
safety study for the treatment of abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysms

Summary: the primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the unifit aorto-uni-iliac (aui) endoluminal stent graft (the "study device") for the repair of abdominal aortic aneurysms (aaas).

this is a phase ii, single-arm, prospective study of the safety of the study device for the repair of aaas. the investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. patients who provide written informed consent will be evaluated for study eligibility within the time period identified under duration of treatment. patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study. after hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient has a aaa that meets one of the following criteria: 1. aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion 2. the aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures * the vessels immediately proximal and distal to the lesion are capable of accommodating the study device * the access artery diameter and profile of the artery are capable of study device delivery. * patient has proximal and distal neck lengths of greater than or equal to 1.0 cm * patient is willing and able to comply with the follow-up regime. * patient has provided written informed consent. exclusion criteria: * patient has an aortic diameter greater than 36 mm. * patients with asa score less than 3 and deemed low risk by the investigator for open surgical repair. * patient has an indispensable inferior mesenteric artery. * patient has a distal landing zone of \ 16 mm in diameter * patient has iliac arteries whose tortuosity prevents passage of the introducer catheter. * if female, patient is pregnant * patient has a life expectancy less than two years. * patient has an allergy to any of the study device materials * patient has coagulopathy or bleeding disorders * patient for whom contrast medium or anticoagulation drugs are contraindicated * patient has an uncontained rupture of the aneurysm. * patient has an active systemic or localized groin infection * patient has a connective tissue disease. * patient has a gfr \< 30 ml/min/1.73m2 * patient has a circumferential mural thrombus at the implantation site. * patient is a candidate for a bifurcated endovascular graft. * patient has an aortic trunk with an angle greater than 90°.

Keywords: unite aaa abdominal aortic aneurysms stent graft
effects of a 4-week acu-transcutaneous electrical nerve stimulation (acu-tens) program on subjects with stable chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the objectives of this study are to investigate the effectiveness of acu-tens (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with copd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with copd exclusion criteria: * allergic to gel * unable to perform spirometry * unable to communicate * no history of infection or exacerbation of respiratory symptoms

Keywords: copd fev1 beta endorphin sgrq acu-tens
acupuncture in stroke rehabilitation

Conditions: Stroke

Summary: the primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors

in this study, we compare the effect on motor functional improvement between a combined acupuncture and strength training program and the strength training alone. the results may allow us to determine whether the acupuncture may bring in additional benefit to the motor recovery in the upper limb in stroke survivors

Eligibility criteria:
inclusion criteria: * after stroke (\>6 months) exclusion criteria: * other neurological diseases
study of chop + campath for t-cell, null cell, or natural killer (nk)-cell lymphoma

Conditions: T-Cell Lymphoma; Lymphoma, Non-Hodgkin's

Summary: primary objective: * to determine the toxicity profile and tolerability of alemtuzumab (campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (chop) chemotherapy (c-chop) in patients with t-cell, null-cell and nk-cell lymphomas. secondary objectives: * to evaluate response rate, overall survival, and disease-free survival in patients with t-cell, null-cell, and nk-cell lymphomas treated with campath + chop chemotherapy. * to assess the incidence of cytomegalovirus (cmv) reactivation in patients with these lymphomas treated with the campath + chop combination. * to determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of glycosylphosphatidylinositol (gpi)-linked proteins.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of non-b-cell, non-hodgkin's lymphoma (including t-cell, null-cell, or nk-cell lymphoma, but excluding lymphoblastic lymphoma) * stage ii, iii, or iv disease requiring chemotherapy * at least one site of measurable disease, 1.5 cm in diameter or greater * age \> or = 18 years * absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor * platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor * creatinine less than 2 x upper limits of normal (uln) * total bilirubin less than 2 x uln (dose reduced vincristine and adriamycin required for bilirubin \> 1.2 mg/dl) * echocardiogram (echo) or multiple gate acquisition scan (muga) documenting a normal ejection fraction prior to chemotherapy * able to give informed consent exclusion criteria: * known central nervous system (cns) involvement * known hiv disease * patients who are pregnant or nursing * any factor which might limit the patient's ability to provide informed consent * life expectancy \< 3 months * patients who are unwilling to agree to use an effective means of birth control while on treatment

Keywords: nk cell lymphoma null cell lymphoma
trial of decongestive lymphatic therapy for lymphedema in women with breast cancer "delta study"

Conditions: Breast Cancer; Lymphedema

Summary: the purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (dlt) in women who have completed treatment for breast cancer and present with lymphedema. this is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (canadian guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage. duration: one year after the last patient is randomized.

randomized patients receive either standard of care or standard of care plus dlt (five massage sessions per week for 4 consecutive weeks). primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. there is an extended follow-up of one year.

Eligibility criteria:
inclusion criteria: * women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm. * patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. this is to ensure that scheduling difficulties with daily treatments do not arise. patients may be currently taking tamoxifen or similar hormonal treatment. exclusion criteria: * clinical or radiological evidence of active disease, either local or metastatic. * history of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.) * previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. patients are eligible after a simple hysterectomy (+/- oophorectomy). * previously undergone massage therapy for arm edema, or has used compression sleeve within the last month. * serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up. * patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm. * unable to commence therapy within 7 days of randomization. * psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Keywords: breast cancer lymphedema treatment massage randomized dlt therapy quality of life decongestive therapy breast cancer related lymphedema
mk0767 in metabolic syndrome-dyslipidemia (0767-016)

Conditions: Metabolic X Syndrome Dyslipidemia

Summary: this is a clinical trial in patients with metabolic syndrome and dyslipidemia to study the effects of mk0767 on triglycerides.


Eligibility criteria:
inclusion criteria: * patients with metabolic syndrome and dyslipidemia age 21 to 65 * patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for metabolic syndrome as defined by ncep exclusion criteria: * patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease * patient is on cyclical estrogen medications * patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, hmg coa reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2
assessment of the nipe in very premature infant ventilated and sedated in neonatal reanimation.

Conditions: Neonatal; Pain Measurement; Reanimation

Summary: the newborn infant parasympathetic evaluation (nipe) was developed as a method of analysis of the heart rate variability. the monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). so far, the measure of the heart failure variability by using the nipe in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.


Eligibility criteria:
inclusion criteria: * infant born very premature before 34 weeks of amenorrhoea + 0 day * age ≤ 7 days * admitted in neonatal reanimation * sedated, intubated, ventilated exclusion criteria: * high frequency oscillation ventilation * heart rate non sinusal * inotropes and atropine * opposition from the guardian of parental authority * difficulty of comprehension or communication making the parental information impossible

Keywords: nipe newborn infant parasympathetic evaluation pain measurement neonatal care