Kornimate/medical-research-clean huggingface dataset:
genetic and epigenetic mechanisms of developing gestational diabetes mellitus and its effects on the fetus

Conditions: Gestational Diabetes Mellitus

Summary: this is a randomized controlled trial of different glycemic targets during tratment of women with gdm with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. this study is interventional, randomised controlled trialr, open-label.

the study aims to clarify the effect of hyperglycemia and its correction, the level of physical activity and consumption of major macro- and micronutrients by women during pregnancy on dna methylation and expression of genes involved in neuroendocrine regulation and development of metabolic diseases in offspring, as well as functional characteristics of human umbilical vein endothelial cells (huvecs). for the purpose of the study women with gdm are randomised to 2 treatment groups per glycemic targets ( very tight and tight-moderate glycemic targets). data on glycenmic levels during the study and consumption of major macro- and micronutrients will be collected using a mobile application with electronic dairies report forms.

Eligibility criteria:
inclusion criteria: * pregnant women with gdm diagnosed according to the russian national consensus and the recommendations of the international association of diabetes and pregnancy study groups (fasting glucose of ≥5.1 mmol/l, and/or ≥10.0 mmol/l after 1 h, and/or ≥8.5 mmol/l after 2 h in oral glucose tolerance test (ogtt) with 75 g of glucose). * gestational age at the time of inclusion in the study 12 weeks 0 days - 31 weeks 6 days * for control group: pregnant women with normal glucose tolerance confirmed by ogtt at 24-31 weeks of gestation. exclusion criteria: * diabetes mellitus type 1 and tipe 2 * other deseases that affect methabolism of carbohydrates * use of drugs that affect methabolism of carbohydrates * malformations of the fetus identifired prior to inclusion to the study.
sugammadex on remifentanil ce for preventing emergence cough in female

Conditions: Gallbladder Diseases

Summary: the purpose of this study is to investigate the optimal ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.

remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. it allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. in addition, cough suppression of remifentanil enables smooth extubation with reduced complications. however, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. reduced ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy under general anesthesia exclusion criteria: * bmi \> 30 kg/m2, respiratory infection, uncontrolled hypertension
a study of the safety and efficacy of injectable risperidone in the prevention of bipolar mood episodes

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

risperdal consta (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar i disorder. this is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of risperdal consta in the prevention of mood episodes in patients with bipolar 1 disorder. this study includes 5 periods: a screening period lasting up to 1 week; an open-label risperdal (oral risperidone) treatment period lasting 3 weeks; an open-label risperdal consta stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with risperdal consta lasting 8 weeks. efficacy will be assessed using the young mania rating scale (ymrs), montgomery-åsberg depression rating scale (madrs), clinical global impressions - severity (cgi-s) scale, medical outcomes study short form 36 (sf-36), and the personal and social performance (psp) scale. safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ecgs), vital signs (pulse and blood pressure), physical examination, body mass index (bmi), and the extrapyramidal symptom rating scale (esrs). oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. risperidone lai i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during db-period)

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable * two or more bipolar mood episodes in the last 2 years excluding current episode * negative pregnancy test exclusion criteria: * history of \> than 4 mood episodes a year during the last two years * patients experiencing a depressive episode * history of antisocial or borderline personality illness * has unstable or serious general medical illness * has received medications disallowed by study criteria.

Keywords: mood episodes bipolar 1 disorder intramuscular injectable risperidone safety and efficacy
endothelial function and imt in survivors of hodgkin's lymphoma

Conditions: Hodgkin's Lymphoma

Summary: the aim of the proposed study is to assess endothelial function and imt, as correlates of cardiovascular disease (cvd), in young adult hodgkin's disease (hd) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.

disease free survival of hodgkin's disease (hd) patients has improved dramatically over the past few decades. with the dramatic advance in patient's survival, the prevention and treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major focus of interest. hd survivors have excess mortality compared with the age-matched general population, even after excluding disease relapse. a considerable proportion of the excess mortality is due to cardiovascular disease (cvd), principally ischemic heart disease and stroke. the proposed study will assess endothelial function in hd survivors, using the non-invasive technique of brachial artery flow-mediated dilation (fmd), by high-resolution ultrasonography. we will also assess imt. the results of these tests are independent predictors of atherosclerosis disease progression and cardiovascular event rates. this is a prospective study comprising 40 young-adult (aged 18-30 years) . the study will comprise 40 survivors of hd: 20 patients treated with chemotherapy and radiotherapy to the chest and 20 patients treated with chemotherapy alone. the patients will be compared to age and sex-matched patients from the data base of the endothelial function laboratory at the heart institute of the sheba medical center. in addition to brachial artery endothelial function assessment, the patients will also undergo a physical examination including anthropometric measurements (height, weight, waist and hip circumference), and blood pressure. the evaluation will also include blood tests for glucose, lipid profile, crp, ast, alt and insulin. a medical history including smoking history and family history of cvd and dyslipidemia will be obtained. patients treated with radiotherapy to the chest will be compared to patients treated with chemotherapy alone and both patients will be compared to healthy controls. the patients will be characterized by age, risk factors for coronary heart disease and endothelial function as assessed by brachial artery fmd. we will establish the rate of endothelial function abnormalities in survivors of hd and its correlation with the other risk factors.

Eligibility criteria:
inclusion criteria: * hodgkin's disease survivors over 18 years old

Keywords: hodgkin's lymphoma cardiovascular disease radiation therapy brachial artery flow-mediated dilation (fmd)
grip: maximum isometric grip strength assessed with three different hand-held dynamometers

Conditions: Grip

Summary: maximum isometric grip strength (migs) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. the the jamar hydraulic hand dynamometer is the current gold standard for measuring migs. for certain age- and activity-groups, alternative devices may be more appropriate. to date, the quality criteria (test-retest-reliability and validity) of the jamar smart hand dynamometer and the martin vigorimeter compared to the current gold standard are not yet investigated. furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.

this quality analysis of test-retest reliability and validity (part 1) serves as a basis for a further sensitivity analysis, whereby in a second step, a database with valid personalised age-, sex- and activity-related reference values for the respective measurement instrument, considering chronic concomitant diseases, is to be generated. the objectives of this study are therefore to 1) assess the test-retest reliability (intrasubject and intersession) and validity of jamar© hydraulic and jamar© smart dynamometers and martin vigorimeter (part 1) and 2) undertake a sensitivity analysis providing valid personalised reference values for precision medicine (part 2). thus, no study has yet comprehensively investigated all relevant influencing factors in a single and thus homogeneous study setting, so bias can be expected from this alone. the findings of this two-step study should enable physicians and therapists to compare the grip strength measurements of their patients with normative values in relation to their age, sex and activity group, as well as to any underlying chronic diseases that may be present. this allows realistic treatment and training goals to be set and patient performance to be interpreted.

Eligibility criteria:
inclusion criteria part 1: * male and female volunteers with age 18-64 years * body mass index \< 30 kg/m2 * informed consent signed inclusion criteria part 2: * male and female volunteers with age ≥ 10 years * informed consent signed (if age \< 14 years, signed by parents or legal guardians) exclusion criteria part 1 and 2: * disease or injury (e.g., musculoskeletal or neurological) that could affect upper extremity strength * physical impairment of the upper extremity (visible swelling or the presence of a splint or cast) * acute pain or infection * cognitive impairment (inability to understand and/or follow directions) * insufficient language of the german language

Keywords: maximum isometric grip strength hand-held dynamometer reference values physical therapy
the effect of two versus ten days application of flammacerium in partial thickness burns

Conditions: Burns

Summary: the objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. however, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. the objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

Eligibility criteria:
inclusion criteria: * patients having partial thickness burns with tbsa of \< 10% exclusion criteria: * patients not seen within 24 hours postburn * patients with only facial burns * patients with electrical or chemical burns * patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent

Keywords: burns partial thickness cerium flamazine randomised clinical trial
the final diagnosis and treatment result of metastatic cervical carcinoma of unknown primary

Conditions: Metastasis Cervical Lymph Nodes of Unknown Primary Carcinoma

Summary: investigate the final diagnosis and treatment result of metastatic cervical carcinoma of unknown primary

carcinoma of unknown primary (cup) is defined as biopsy-proven metastasis of an epithelial malignancy in the absence of an identifiable primary site after complete history and physical examination, basic laboratory studies, chest x-ray and additional directed studies indicated by positive findings during the initial work-up. it is characterized by its slow local development and its high metastatic potential.1,2 patients with cup represent 4-10% of all new cancer patients.3,4 the presenting sites of metastasis identified pathologically, radiographically or by physical examination were found most frequently in the lymph nodes (37.1%), followed by the liver, bone, lung, pleura/pleural space, brain, peritoneum, adrenal and skin. of the lymph nodes of metastasis, the supraclavicular cervical area is the leading site (31.3%), followed by the mediastinum, axilla, retroperitonium, and inguina.5 the incidence of metastatic cervical cup (mccup) varies between 2% and 9% of all head and neck cancers.6-8 the level of cervical metastatic involvement may give some clue as to the likely primary site. a submandibular mass (level i) would most commonly be related to a primary in the oral cavity or skin. level ii nodes, including the jugulodigastric node, may point to a primary in the oral cavity, oropharynx, or supraglottic larynx. tumours of the nasopharynx generally spread to level ii or the posterior triangle, as well as retropharyngeal nodes. middle and lower jugular nodes (levels iii and iv) are more likely related to a laryngeal or hypopharyngeal cancer. metastatic disease restricted to the supraclavicular region is often due to an infraclavicular primary site.9 the prognosis is different according to the involved lymph node level and possible primary site. modern cancer management relies heavily on recognition of the primary tumor; thus the absence of a primary site poses major diagnostic and therapeutic problems. the patient benefits from identification of the initial tumor site because postoperative irradiation ports may be reduced and because surveillance for recurrence may be improved.10 in order to identify the likely primary site of mccup and compare the prognoses of known and unknown primary groups, we report the results according to the different levels of metastatic cervical lymph nodes.

Eligibility criteria:
inclusion criteria: * cases of metastatic cervical carcinoma of unknown primary exclusion criteria: -

Keywords: metastatic carcinoma cervical lymph nodes unknown primary diagnosis result
usability study of a neuropsychological intervention program based on virtual reality in adults with parkinson's disease

Conditions: Parkinson Disease

Summary: nowadays, several strategies for treating neuropsychologic function loss in parkinson disease (pd) have been proposed, such as physical activity performance and developing games to exercise the mind. however, few studies illustrate the incidence of these therapies in neuronal activity. this work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of pd patients. for this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. the study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

nowadays, several strategies for treating neuropsychologic function loss in parkinson disease (pd) have been proposed, such as physical activity performance and developing games to exercise the mind. however, few studies illustrate the incidence of these therapies in neuronal activity. this work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of pd patients. for this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. the alpha and beta bands power behaviour were determined by evaluating the electroencephalography (eeg) signals obtained during the execution of control tests and games of the "hand physics lab" software, from which five games related to attention, planning, sequencing, concentration, and coordination, were taken. the study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Eligibility criteria:
inclusion criteria: * parkinson disease (neurologist diagnosed) * both gender * informed consent accepted * adults * stage 2 and 3 in the hoehn yahr scale exclusion criteria: * mental diseases * migraines * pregnancy

Keywords: parkinson's disease virtual reality cognitive functions alpha band beta band cerebral lobes electroencephalography
effect of metformin on insulin sensitivity and pan-arterial vascular function in adults with metabolic syndrome

Conditions: Metabolic Syndrome; Insulin Sensitivity

Summary: the purpose of this study is to look at how insulin (a hormone that helps the cells get energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels and blood flow in the smaller blood vessels in the arm) and how metformin (a drug that makes you more sensitive to insulin) affects insulin's action on the blood vessels.

in our protocol, we will study vascular function using pulse wave velocity (pwv) augmentation index (ai), flow mediated dilation (fmd) and contrast enhanced ultrasound (ceu) as well as insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age 18-60 years. they will each be studied 4 times,before and after two 12-wk interventions (randomly assigned) as follows: 1) placebos and 2) metformin . this is a cross-over design.

Eligibility criteria:
inclusion criteria: * age 18-60 * no smoking the past 6 months * normal screening labs or no clinically significant values-except those listed below * must have 3 of the following 4 characteristics established by ncep-aha-nhlbi * males waist circumference greater than 40 inches, females greater than 35 inches * blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent * fasting plasma triglycerides \>150 or hdl \<40 (males) \<50 (females) * fasting blood sugar \>100 but \<126 * subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval. * ace inhibitor * arb * hmg coa reductase inhibitor * beta blocker * calcium channel blockers * alpha-adrenergic antagonist exclusion criteria: * smoking presently or in the past 6 months * hba1c ≥ 6.5 * glucocorticoids-eg: prednisone, dexamethasone * any known sensitivity or intolerance to metformin * any chronic gi disorders such as irritable bowel syndrome or crohns disease * history of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease. * history of malignant or metabolic disorders including diabetes * presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by pi) * hypersensitivity to perflutren (contained in definity) * pregnant or breastfeeding
one week parathyroid hormone-related protein (pthrp) iv dose escalation study

Conditions: Osteoporosis; Humoral Hypercalcemia of Malignancy; Hyperparathyroidism

Summary: this is a dose escalation study to determine the maximum tolerable dose of parathyroid hormone-related protein, pthrp, that can be given safely over one week. the investigators plan to infuse low doses of intravenous pthrp to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (hhm) or an increase in bone formation as occurs in hyperparathyroidism (hpt). additionally, the investigators will assess the direct influence of pthrp on markers of bone turnover, and plasma 1,25 (oh)2 vitamin d regulation in healthy human volunteers.

during this research the investigators administer pthrp to healthy young volunteers in a controlled, continuous intravenous manner. as research subjects complete the week-long study without adverse effects, the dose of pthrp will be increased in later subjects. in the event of a significant adverse effect, immediate action will be taken to reverse it. the investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of pthrp has on vitamin d metabolism, markers of bone turnover and fractional excretion of calcium.

Eligibility criteria:
inclusion criteria: * healthy caucasian subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the clinical \& translational research center at the university of pittsburgh medical center (upmc) montefiore exclusion criteria: * pregnancy * any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological, malignant or rheumatologic diseases * body mass index great than 30 * anemia * significant alcohol or drug abuse * baseline hypotension or hypertension * abnormal screening labs * use of certain chronic medications excluding oral contraceptives * receiving an investigational drug in the last 90 days * previously receiving pth or pthrp * african-american race

Keywords: endocrine system diseases musculoskeletal system diseases hormones malignancy postmenopausal women bone metabolism