Kornimate/medical-research-clean huggingface dataset:
handheld ultrasound-assisted versus palpation-guided labor combined spinal-epidural analgesia

Conditions: Labor Analgesia

Summary: parturients who need combined spinal-epidural analgesia for labour analgesia are randomly assigned to two groups. for the handheld ultrasound-assisted technique group, ultrasound with 3d navigation function is used to determine the needle insertion point and the insertion angle. for the conventional palpation-guided technique group, the interspinous space is detected by palpation. procedure time, the number of needle passes, the number of needle insertion attempts, success rate, and complications are compared.

this study aims to determine whether handheld ultrasound-guidance can reduce procedural time for labor combined spinal-epidural analgesia compared with conventional surface landmark-guided technique.

Eligibility criteria:
inclusion criteria: - adult parturients with asa physical status classification i, ii or iii requiring a combined spinal-epidural for labor analgesia exclusion criteria: * contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.) * difficulty in communication * severe cardiac disease * history of spine surgery * anatomical abnormality of the lumbar spine * age under 18
optimization of systemic treatment strategies in elderly patients with advanced solid malignancies

Conditions: Colorectum Advanced Malignancies; Breast Advanced Malignancies; Prostate Advanced Malignancies

Summary: the purpose of this study is to assess whether the presence of a myelodysplastic syndrome (mds) , idiopathic cytopenia of undetermined significance (icus) or idiopathic dysplasia of undetermined significance (idus), correlates with treatment intensity and clinical outcome in older patients with advanced malignancies receiving palliative chemotherapy. we will study the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with treatment related toxicity as well. we hypothesize that a standardized flow cytometry test to determine bone marrow capacity, a comprehensive geriatric assessment and/or measurement of human body composition with computerized tomography will provide an accurate tool to optimize treatment strategies in elderly patients with advanced malignancies.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years * diagnosis of advanced cancer of colorectum, breast or prostate * standard first line palliative treatment with cytotoxic agents will be started (folfox, xelox, capecitabine, paclitaxel or docetaxel) * estimated life expectancy ≥ 3 months * able to give informed consent * who performance status ≤ 2 * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the treatment and follow-up schedule; those conditions should be assessed with the patient before registration in the trial * no other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study. * before patient registration, written informed consent must be given and documented to ich/eucgcp, national/local regulatory requirements and the local rules followed in our institution exclusion criteria: * presence of cytopenia due to iron-, vitamin b12 and folic acid deficiency or hemolysis, unless adequately supplemented. * creatinine clearance ≤ 30 ml/min * serum ast and alt ≥ 2.5 x uln, in case of liver metastases serum ast and alt ≥ 5 x uln * in case of therapy with docetaxel/paclitaxel serum bilirubin ≥ 1.5 x uln
vldl-triglyceride kinetics in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. triglycerides (tg) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. evidence suggests that increased concentration of very low-density lipoprotein triglyceride (vldl-tg) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia. the objective of this study was to investigate vldl-tg kinetics and aspects of peripheral vldl-tg metabolism, i.e. to what extent vldl-tg associated fatty acids (fa) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled vldl-tg tracers.


Eligibility criteria:
inclusion criteria: exclusion criteria: * known disease except type 2 diabetes (type 2 diabetic subjects) * smoking * alcohol abuse * prescription medication expect oral antidiabetics (type 2 diabetic subjects)

Keywords: type 2 diabetes diabetic dyslipidemia vldl-tg kinetics vldl-tg metabolism
the effects of specialty coffee on cognitive function in people with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: coffee has been found to have beneficial effects on cognitive function and blood sugar control. benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. these effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (cga). this polyphenol has been found to be more bioavailable in certain coffees, known as "speciality coffee" as defined by the specialty coffee association of america, depending on agriculture, roasting, and brewing method. this current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high cga specialty coffee group and a conventional coffee control group. participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. the length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. at the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). cognitive function will also be assessed at the beginning of the 4-week run-in period.


Eligibility criteria:
inclusion criteria: * age 55-70 years * formal diagnosis of type 2 diabetes for 3 years or more * current coffee drinkers, 4 or fewer cups daily (a cup is 8 oz) exclusion criteria: * insulin-dependent * consuming on average more than 4 cups of coffee daily * regularly consuming specialty coffee (participants will be provided with a list of these coffees)
study assessing safety, pharmacokinetics and efficacy of cc-223 with either erlotinib or oral azacitidine in advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer

Summary: the main purpose of this first study combining an investigational dual mtor inhibitor, cc-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. men and women, 18 years or older, with histologically or cytologically-confirmed, stage iiib/iv non-small cell lung cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an epidermal growth factor receptor inhibitor) for advanced disease. there is no restriction on the number of prior treatment regimens allowed. 2. eastern cooperative oncology group performance score of 0 to 1. 3. adequate organ function. 4. adequate contraception (if appropriate). 5. consent to retrieve archival tumor tissue. 6. consent to repeated tumor biopsy (dose expansion phase). exclusion criteria: 1. prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in arm a. 2. symptomatic central nervous system metastases. 3. acute or chronic pancreatitis. 4. persistent diarrhea or malabsorption \> grade 2, despite medical management. 5. impaired cardiac function or significant cardiac disease. 6. diabetes on active treatment, fasting blood glucose \> 126 mg/dl, hba1c \> 6.5%. 7. known human immunodeficiency virus, chronic hepatitis b or c infection. 8. prior treatment with an investigational dual torc1/torc2, pi3k, or akt inhibitor. prior treatment with rapalogs is allowed. 9. major surgery \< 2 weeks prior to starting study drugs. no specific wash out is required for radiotherapy. subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug. 10. pregnant or breastfeeding, inadequate contraception. 11. history of concurrent second malignancies requiring ongoing systemic treatment.

Keywords: neoplasms pulmonary lung cancer cancer of the lung stage iiib non-small cell lung cancer iv non-small cell lung cancer non-small cell lung cancer
total splenectomy vs partial splenectomy in non-malignant hemoglobinopathies : study comparing the effectiveness

Conditions: Splenectomy; Status

Summary: partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. the aim of this treatment is to decrease transfusion. the main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. but the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.


Eligibility criteria:
inclusion criteria: * children between 0- 18 years olds * total or partial splenectomy * non malignant hémoglobinopathies exclusion criteria: - total or partial splenectomy outside of non malignant hemoglobinopathies

Keywords: pediatrics non-malignant hemoglobinopathies comprative effectivness partial splenectomy total splenectomy
patient education program for osteoarthritis with exercise included

Conditions: Osteoarthritis

Summary: the purpose of this study is to investigate if inclusion of exercise in an education program for patients with osteoarthritis can improve self efficacy, self-perceived health and function.

osteoarthritis (oa) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.the predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. treatment often consists of medication. later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. physical exercise may also reduce the need for hospital care after knee joint replacement.research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . accordingly, guidelines recommend education and exercise as a core treatment for osteoarthritis. since 1994, primary health care in malmö has used a patient education programme directed towards oa.the program does not include exercise. in 2007-09 a study was made to investigate this education program.the study showed improvements in self-perceived health and in a few functional tests but not in self-efficacy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteoarthritis exclusion criteria: * must be able to speak and understand swedish

Keywords: musculoskeletal diseases osteoarthritis joint diseases arthritis rheumatic diseases
reduction of adverse drug events and readmissions

Conditions: Pharmacogenomic Testing for Medication Management

Summary: pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

pharmocogenomic. a multicenter, observational study to evaluate the use of a pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.

Eligibility criteria:
inclusion criteria patients may be included in the study if they meet all of the following inclusion criteria: 1. male or female patients of 25 years of age or older who are able to give their written informed consent to participate in a clinical study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them. 2. patient underwent pgx testing for alleles appropriate to the target drugs within the prior 120 days ("index pgx test assessment"); 3. patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index pgx test assessment"), including over-the- counter medications; 4. patient has a history of at least one tdae over the 24-month period preceding the pgx test assessment, or has experienced inadequate efficacy from a target drug. exclusion criteria patients will be excluded from the study if any of the following criteria apply: 1. patient is currently hospitalized; 2. patient's medical and medication history is unavailable over the 120-day period preceding the pgx test assessment; 3. patient is unable to provide an accurate history due to mental incapacity; 4. patient is known to have undergone prior pgx testing for genes specific to the target drug(s), exclusive of the pgx test relating to this study.
preoperative anxiety in pediatric reconstructive burn patients: the role of virtual reality hypnosis

Conditions: Anxiety

Summary: children with burns often require repeated reconstructive surgeries. these children tend to develop high levels of anxiety before coming to the operating room. preoperative sedation, while somewhat effective in relieving this anxiety, has a number of side effects. the researchers hypothesized that preoperative anxiety could be effectively reduced by the utilization of a device which induces a relaxing hypnotic state through emmersion in a virtual reality environment.

the virtual reality environment is created by a virtual reality hypnosis (vrh) device. the patient wears a headset which contains video and audio display. a twenty minute program is viewed, which guides the patient into a relaxed state via soothing audio and video input.

Eligibility criteria:
inclusion criteria: * child presenting for reconstructive burn surgery exclusion criteria: * visual or auditory difficulties

Keywords: preoperative anxiety burn reconstruction
cholesterol metabolism in heterozygous phytosterolemia

Conditions: Cardiovascular Disease

Summary: the purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.

a plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. the study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. a 4 week washout period will separate the two treatment periods. plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13c-cholesterol and deuterium oxide, respectively.

Eligibility criteria:
inclusion criteria: * heterozygous for phytosterolemia, wild-type. exclusion criteria: * pregnant, * previous heart attack, * kidney disease.
the influence of benign prostatic hyperplasia on bladder function

Conditions: Prostatic Hyperplasia

Summary: lower urinary tract symptoms(luts) are the main symptoms of benign prostatic hyperplasia(bph), a benign but progressive disease which can advance to be with overactive bladder(oab) symptoms. moreover, luts and oab symptoms can badly influence patients' especially the elderly's quality of life. therefore, it appears to be urge to carry out researches on the functional impairment of bladder along with the advance of bph. besides, the management aimed at improving the luts and oab symptoms come to be the key one among the management of bph. for a long period, medication and surgery sustain to be the two most common therapies for bph patients. both patients and urologists prefer pharmacotherapeutics to surgery，which contributes to the rising number of bph patients companied with oab symptoms and storing symptoms complaint post-surgery. in fact, investigators usually find bladder impairment macroscopically in the bph surgery: mild may be the trabeculation, worse can be the cabin, and severe may be the diverticula. furthermore, it's not uncommon that patients with a long bph history continually suffer from dysuria after surgery due to the detrusor muscle weakness. consequently, investigators need to catch a moment when investigators should operate on such a patient in order to harvest a satisfying outcome. and perhaps the moment should be ahead of the existing guideline suggests. thus, for understanding the influence of bph on bladder function, investigators plan to conduct a prospective, case-control study recruiting in-patients with different degree of obstruction. our team wish that such a clinical trail could provide valuable evidence for us to find out relatively better operating timing and serial indications. for the purpose of improving the quality of life and prolong life-span, investigators design the study above to maximum the operating outcome and minimize the bladder dysfunction.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent. 2. the bph in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) maximal urinary flow rate less than 20 ml per second, 2) volume of prostate more than 20ml measured by transrectal ultrasound 3) psa ranges from 0 to 10ng/ml 4) ipss\>1 exclusion criteria: 1. the lower urinary tract obstruction caused not by bph 2. had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder. 3. using medications known to affect urination or had a severe concomitant disease
study of the prevalence of cosavirus and salivirus infections, two new genera of picornaviridae, in infants

Conditions: Gastro entérite

Summary: cosavirus and salivirus are two new genera of picornaviridae and are responsible for acute diarrhoea. they have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied. to date, no study on these two viruses has been conducted in france to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea. the aim of this study is thus to: * show that these viruses are in circulation in france in infants younger than 5 years old and that the proportions are similar to those reported in the literature. * confirm the relationship between the diarrhoea and the infection with these viruses.


Eligibility criteria:
inclusion criteria: * children younger than 5 years * children hospitalized or consulting at dijon chu during the 12 months of the study for acute gastroenteritis. acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever for controls * children younger than 5 years old * children hospitalized or consulting at dijon chu during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria). exclusion criteria: * persons without national health insurance cover * children older than 5 years. * children presenting chronic diarrhoea (\> 2 weeks) (e.g. crohn and uc) * children with immune deficiency. * children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission for controls * persons without national health insurance cover * children older than 5 years. * children with chronic diarrhoea (\> 2 weeks) (e.g. crohn and uc) * children with immune deficiency.
patients 60 years and older suffering from mandibular fractures registry

Conditions: Mandibular Fractures

Summary: approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. all patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.

patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. all patients will be treated (surgical or non-surgical) and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment. data collection will include patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications). radiographs and/or other images (e.g. ct scan) taken as per standard of care will be collected within the registry. primary objectives are to obtain epidemiological data and describe the most common mandibular fracture patterns in older patients, to explore the relationship(s) between the treatment of mandibular fractures and its outcome in older patients, to identify risk factors and initiating factors of elderly related to mandible fracture events and to describe concomitant fractures associated with mandibular fractures in older patients.

Eligibility criteria:
inclusion criteria: * age \> 60 years at the time of the injury * diagnosis of any kind of mandibular fracture * informed consent obtained, i.e.: * ability to understand the content of the patient information/ informed consent form (icf) * willingness and ability to participate in the clinical investigation according to the registry plan (rp) * signed and dated ec/irb approved written informed consent or for patients who are not able to provide independent written informed consent: written consent provided according to defined and irb/ec approved procedures exclusion criteria: * patients with previous history of mandibular fractures or mandibular defects treated surgically * participation in any other medical device or medicinal product study within the previous months that could influence bone healing and the results of the present study in the opinion of the treating physician

Keywords: fracture fixation surgical treatment non-surgical treatment