Kornimate/medical-research-clean huggingface dataset:
calcium electroporation as a treatment for cutaneous and subcutaneous malignant tumours

Conditions: Cancer

Summary: phase ii investigation of calcium electroporation as a treatment for cutaneous and subcutaneous malignant tumours.

this will be a non-randomized phase ii trial with the objective of evaluating the clinical response rate of calcium electroporation treatment of malignant tumours of the skin and assessing treatment impact on quality of life. this study will investigate the response rate of calcium electroporation treatment of skin metastases and malignant wounds in a real-world setting, in three different cancer centres in northern europe. the centres aim to treat a total of 30 patients with cancer in the skin of any histology. the patients will be treated once and followed with regular examinations for 12 months, starting from first treatment day. all patients will have been offered the standard of care and all available alternatives before entering the protocol. calcium electroporation will not be compared to other means of treatment. the primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. a subset of patients will undergo mr scans after treatment and another subset of patients will be interviewed regarding treatment impact on quality of life.

Eligibility criteria:
inclusion criteria: * trial subject ≥ 18 years. * trial subject must be able to understand the participant information. * histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. * the patient must have been offered other relevant standard treatment for their cancer disease. * the patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more. * the patient can undergo radiation therapy, provided that the treatment field does not involve treated area. * performance status ecog/who ≤2. * at least one cutaneous or subcutaneous tumour measuring up to 3 cm. * both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch). * signed informed consent. exclusion criteria: • pregnancy or lactation

Keywords: calcium electroporation cancer skin
a multiple dose investigational drug study in patients with type 2 diabetes (mk-0941-005)

Conditions: Type 2 Diabetes Mellitus

Summary: a multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. the primary hypotheses of the study are that multiple daily mk-0941 in subjects with t2dm with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.


Eligibility criteria:
inclusion criteria: * nonsmoking male or female (of non-child bearing potential) * diagnosis of type 2 diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents * panel e only (mk0941 60 mg before 2 meals each day): diagnosis of type 2 diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more exclusion criteria: * subject is on insulin or a peroxisome proliferator-activated receptor (ppar) agonist * subject is on 3 or more oral anti-diabetes medications * subject has a history of type 1 diabetes * subject has a diagnosis of glaucoma or is blind * subject has had trauma to one or both eyes
impact of motor and oral motor function on quality of life in children with sma

Conditions: Spinal Muscular Atrophy Type I

Summary: the aim of this study is to investigate the impact of motor and oral motor functions on the quality of life in children aged 2-4 years diagnosed with spinal muscular atrophy (sma) type i. in the study, the neuro-sensory-motor developmental assessment (nsmda) was used to evaluate motor functions, the functional oral intake scale (fois) to assess oral motor function, the behavioral pediatric feeding assessment scale (bpfas) to evaluate children's attitudes towards feeding, and the pediatric quality of life inventory (pedsql) neuromuscular module to assess quality of life.


Eligibility criteria:
inclusion criteria: * diagnosed with spinal muscular atrophy type i * being between the ages of 2-4 * families volunteering to participate in the study exclusion criteria: * accompanied by another chronic disease other than sma * the mother or father has a cognitive problem that prevents them from expressing themselves * the mother or father is illiterate

Keywords: spinal muscular atrophy type i oral motor function motor function quality of life
dmso efficacy in ic/pbs patients during and after treatment

Conditions: Cystitis, Interstitial

Summary: the purpose of this study is to examine the efficacy of dimethylsulphoxide (dmso) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

the modern treatment of ic is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. amitryptiline) and intra-vesical instillation (e.g. dmso, steroids, heparin). these treatments were found to be effective in a number of studies and are approved by the fda. however, the optimal duration of intra-vesical instilation is not known. all patients with ic (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of dmso. all patients will fill an o'leary-sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.

Eligibility criteria:
inclusion criteria: * patients with ic according to international continence society: * more than 6 month of pelvic pain * urinary frequency, urgency, dyspareunia exclusion criteria: * genitourinary tract infection * known genitourinary malformation
copeptin and arterial hypotension in critically ill paediatric and neonatal intensive care patients

Conditions: Arterial Hypotension in Critically Ill Neonatal and Pediatric Patients

Summary: blood copeptin will be measured during the routine treatment of neonates, children and adolescents on the intensive care unit of the university children's hospital zurich at different time points (admission, 12, 24, 48, 96, 168 hours after admission). these values will be primarily analysed for their variability and their association with arterial hypotension. blood samples will be drawn together with otherwise medically indicated blood withdrawals to avoid extra harm. further, copeptin values will be compared to clinical and vital parameters, all of them open-label available during clinical routine. copeptin's predictive value for patients' outcome will be analysed as secondary outcome.


Eligibility criteria:
inclusion criteria: * age: first day of life until 18th birthday. * ability of the care taker or the adolescent (if≥14 years of age) to understand verbal and written instructions and informed consent in german. exclusion criteria: * care taker or adolescent (if ≥14 years of age) unwilling to give written informed consent. * care taker or adolescent (if ≥14 years of age) not understanding german and without a family member able to translate. * adolescent (if ≥14 years of age) unwilling to give written informed consent following sedation \< 24 hours. * care takers of long-term sedated (\>24 hours) adolescents (if ≥14 years of age) unwilling to give written informed consent or not present within 24 hours.
the metabolic effect of walnuts in healthy subjects

Conditions: Lipid Metabolism Disorders

Summary: the objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.

the objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals. the metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. we want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. in a third group we will test what food is omitted if no specific instructions are given. furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.

Eligibility criteria:
inclusion criteria: * postmenopausal healthy women and healthy men * age \>50 yrs * written informed consent prior to study participation exclusion criteria: * known allergy to nuts * evidence of alcohol (women \>70g/week, men \>140g/week), tabacco or drug abuse * obesity ≥35 kg/m2 * diabetes mellitus * hypertension \>140/90 mmhg or history of hypertension * ldl-cholesterol \>190 mg/dl, triglycerides \> 350 mg/dl * history of atherosclerotic disease * liver disease of any etiology * kidney disease of any etiology (gfr \< 60 ml/min/1.73) * uncontrolled thyroid disease or other endocrine diseases * acute or chronic inflammatory diseases * active malignancy * current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin e, hormonal replacement therapy * major surgical intervention within 3 months (or planned)
acute effects of cold exposure on cognitive function

Conditions: Cognitive Function

Summary: this is a randomized controlled human exposure crossover study. investigators aims to assess the acute effects of low-temperature exposure on cognitive function and the underlying mechanisms.

the investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in shanghai, china. each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. during the exposure session, each subject will be requested to rest. health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. health examinations include cognitive function tests and magnetic resonance imaging. investigators plan to collect blood and urine samples.

Eligibility criteria:
inclusion criteria: * living in shanghai during the study period; * body mass index \> 18.5 and ≤ 28; * right-handed; * receiving or having received higher education; * with the ability to read and understand chinese smoothly. exclusion criteria: * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; * subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases; * subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * subjects with color vision disabilities.

Keywords: low temperature randomized controlled trial cognitive function
screening of liver fibrosis in adults without known liver disease

Conditions: Liver Fibrosis

Summary: sirius is the "serious" response to the prevalence of liver cirrhosis in slovakia. we plan to screen adult slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or fib-4 score (in outpatient clinics).

according to the lancet gastroenterology and hepatology, slovakia ranks at the top of the prevalence of liver cirrhosis in the world. moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. sirius is the response conceived by the governing board of the slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.

Eligibility criteria:
inclusion criteria: * adult, written informed consent exclusion criteria: * unable to provide sufficient reliable information for any reason * withdrawal of the consent, anytime * acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction \< 2 months, operated on \< 2 months, other) * chronic disease interfering with the endpoint (malignancy \< 2 years; decompensated chronic disease such as chronic heart disease with dyspnea new york heart association nyha 2+, chronic obstructive pulmonary disease copd gold b+, other) * chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis

Keywords: liver fibrosis screening non-alcoholic fatty liver disease alcohol associated liver disease
healthy aging and memory study

Conditions: Alzheimer Disease

Summary: this project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in alzheimer's disease (ad) primary prevention trials.

this project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in ad primary prevention trials. the new or improved measures that have been developed will then be evaluated in 650 nondemented subjects enrolled in a simulated alzheimer's disease prevention trial. once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls.

Eligibility criteria:
inclusion criteria: * 75 years or older. * fluent in english or spanish. * stable medical condition for four weeks prior to screening visit. * stable medications for four weeks prior to screening visit. * either cognitively normal, or mild cognitive impairment. if mci, the subject's cdr at screening have a global score of 0.5. * mmmse score greater than 88 for subjects with at least 8 years education, or greater than 80 for subjects with less than 8 years education, and fcsrt total free plus cued recall score greater than 44 with 3 learning trials. * willing to participate in four to five year follow-up study. * willing to identify person who can serve as informant. * at least six years education or work history sufficient to exclude mental retardation exclusion criteria: * meets dsm iv criteria for dementia * history of clinically significant medical illness that would interfere with participation in trial, including active malignancy, myocardial infarction, or cerebrovascular accident within the past year * alcohol or substance abuse and/or active major psychiatric disorders * concurrent participation in a clinical drug trial * history of mental retardation

Keywords: prevention
involvement of viral infections in the pathogenesis of chronic lymphocytic thyroiditis

Conditions: Autoimmune Diseases; Chronic Lymphocytic Thyroiditis

Summary: autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common. viral infections are the main environmental factors suspected of triggering autoimmune diseases. several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. however, the precise identification of the viruses involved remains to be established. it has been shown for the first time by the 2005 phrc that enteroviral rna is present in perioperative specimens of thyroid tissue. however, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies it has been recently published that parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.


Eligibility criteria:
inclusion criteria: * patients participating in phrc 2005 "involvement of enteroviruses in tlc pathogenesis" * inclusion of tlc: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes * inclusion of controls: absence of significant lymphocyte infiltrate exclusion criteria: * persons refusing to participate in research
objective diagnostic markers and personalized intervention in mdd patients

Conditions: Depressive Disorder, Major

Summary: major depressive disorder (mdd) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. it's reported that the global burden caused by mdd will be up to the second rank among all the disease burdens by 2020. china is also confronted with the daunting challenges against mdd. it's assessed that the monthly incidence of mdd is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. however, to date, the pathogenesis of mdd is obscure and the current therapies don't work well. therefore, it's urgent and critical to elucidate the pathogenesis of mdd, to develop early diagnostic criteria and effective intervention in mdd. considering the diversity of weights on genetic factor and environmental factor in mdd, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of mdd for classifying mdd into "genetic type", "environmental type" and "others" based on a case-control study. we next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among mdd, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of mdd . the investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in mdd patients. finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in mdd patients.


Eligibility criteria:
1. for mdd group: inclusion criteria: * age between 18-55, male or female; * the diagnosis of mdd consistent with dsm-iv (m.i.n.i) * first-episode or relapsed; * certain ability of reading and writing to complete the questionnaire survey and psychological assessment. * all participants provide written confirmation of informed consent prior to engaging the study protocol. exclusion criteria: * current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment; * severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors; * not signed the informed consent; * been engaging other studies. 2. for healthy control group inclusion criteria: * age between 18 and 55 years at the time of enrollment; * providing written confirmation of informed consent prior to engaging the study. exclusion criteria: * lifetime or current diagnosis of any mental diseases; * severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors; * not signed the informed consent; * been engaging other studies.
feasibility study for robotic endomicroscopy to better define resection strategies (persee)

Conditions: Cancer of Digestive System; Ovarian Cancer

Summary: this study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pcle) and needle-based confocal laser endomicroscopy (ncle). contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. that may lead to an incomplete thus useless surgery and delay the right treatment. the objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

this study involves several innovations including : * the robotization of the confocal miniprobe for a better an d more precise handling of the probe * the use of different contrast agent and administration mode (fluorescein, patented blue v, indocyanine green via intravenous, interstitial or topical administration) * the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Eligibility criteria:
inclusion criteria: * patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer * patient able to give written informed consent exclusion criteria: * allergy to fluorescein * allergy to patented blue * allergy to icg * previous life-threatening allergic reactions and known hypersensitivity * pregnancy or breast-feeding * history of cardio-pulmonary disease (including bronchial asthma) * restricted renal function * patient under a beta-blockers treatment * patient who cannot give written informed consent

Keywords: endomicroscopy optical biopsy exploratory surgery resection surgery robot-assisted peritoneum carcinosis inflammatory rectum cancer liver cancer ovarian cancer digestive cancer pancreas cancer duodenum cancer
bms-646256 in obese and overweight type 2 diabetics

Conditions: Obesity and Type 2 Diabetes

Summary: this is a placebo-controlled, randomized, double-blind, parallel arm, multicenter, dose-ranging phase iib trial to assess glycemic and weight loss efficacy and safety of bms-646256 in overweight and obese patients with type 2 diabetes who have been treated with diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (hba1c \>7% and hba1c\<10%).


Eligibility criteria:
inclusion criteria: * patients aged 18-70 years and bmi ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (hba1c \>7% and hba1c\<10%). exclusion criteria: * pregnancy * anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy * history of myocardial infarction in the prior six months/ history of heart failure defined as new york heart association functional class i, ii, iii or iv/ history of symptomatic arrhythmia * active hepatic disease/ any documented muscle disease * history of multiple sclerosis/ baseline history of tremors, ataxia, anxiety or dizziness * seizures within the last year, stroke, and transient ischemic attack/ known history of schizophrenia, dementia, or bipolar disorder as defined by dsm iv criteria. * currently depressed subjects or a ces-d score greater or equal to 16 at the screening visit or at baseline (day 1)/ history of suicide attempt or ideation * previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ weight loss greater than 5 kg in the prior 3 months

Keywords: wheight management in t2d