Kornimate/medical-research-clean huggingface dataset:
incidence and factors involving cesarean delivery after epidural analgesia for labor

Conditions: Cesarean Section; Epidural; Anesthesia

Summary: the rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. the aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. besides, factors associated with the rate of cesarean delivery were studied.

epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. some papers revealed the increasing in the rate of cesarean delivery. the main reason is assume to be a failure to progress labor after epidural analgesia. however, the recent report from cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication. the rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. the aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. besides, factors associated with the rate of cesarean delivery were studied.

Eligibility criteria:
inclusion criteria: * age\>,= 18 years * accept epidural analgesia for labor * asa classification i-ii exclusion criteria: * unable to communicate thai

Keywords: epidural analgesia labor pain cesarean section rate
a glycemic control evaluation of glimepiride versus rimonabant on top of metformin in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (hba1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. the main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and hdl-cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

the total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

Eligibility criteria:
inclusion criteria: * patients with legal age * body mass index \>27kg/m2 * type 2 diabetes as defined by world health organization (who) criteria, treated with metformin for at least 6 months and with a stable dose of metformin \>=1500 mg/day for at least three months * hba1c \>=7% and \<=9% at screening visit exclusion criteria: * weight loss \> 5 kg within three months prior to screening * presence of any clinically significant endocrine disease according to the investigator * presence of type 1 diabetes * presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer * previous participation in a clinical study with rimonabant * absence of effective medical contraceptive method for females of childbearing potential * within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction * within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment * presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: diabetes metformin
clinical trial of a supporter-targeted intervention to improve outcomes in recent sexual assault survivors

Conditions: Stress Disorders, Post-Traumatic; Helping Behavior; Help-Seeking Behavior; Stress; Relationship, Social; Sexual Assault; Sexual Violence; Social Interaction

Summary: communication and recovery enhancement (care) is a 2-session early intervention for survivors of recent sexual assault and their supporters that aims to improve supporters' ability to respond effectively. the goal of this pilot trial is to understand the acceptability and preliminary efficacy of two versions of care: a version in which survivors and supporters attend both sessions together (dyadic care) and a version in which supporters attend sessions alone (supporter-only care). survivors aged 14+ with elevated posttraumatic stress symptoms will enroll with a supporter of their choosing. dyads will be randomized to dyadic care, supporter-only care, or waitlist control, and will complete self-report assessments at baseline, post-session-1, and follow-ups (1, 2, and 3 months post-baseline). results will be used to inform future changes to care and determine whether a fully-powered randomized controlled trial is warranted.


Eligibility criteria:
inclusion criteria (survivors): * age 14+ years * can speak/read english or spanish * have access to a zoom-capable device * screened for eligibility within 10 weeks of sexual assault, defined as any unwanted, distressing sexual contact (e.g., unwanted touching, coerced sexual activity, rape) * able to attend first study session within 2 weeks of screening * elevated ptsd symptoms at screening as operationalized by a primary care ptsd screen score of 2/5 or above * able to identify an eligible supporter * have a way to receive survey links and complete surveys privately (i.e., without potential device or account access by the supporter) inclusion criteria (supporters): * age 14+ years * can speak/read english or spanish * have access to a zoom-capable device * able to attend first study session within 2 weeks of survivor's screening * are in contact with the survivor at least once a week * in the opinion of the survivor, are able to make an independent decision about whether or not to participate in the study * have a way to receive survey links and complete surveys privately (i.e., without potential device or account access by the survivor) exclusion criteria (survivors): * active psychosis * active suicidal intent exclusion criteria (supporters): * perpetrated the sexual assault * engaged in severe past-year violence or abuse (as defined by the survivor) against the survivor * the survivor has not told the supporter about the sexual assault at the time of screening and was not already planning to tell the supporter * in the opinion of the survivor, relational conflict exists between the survivor and supporter that potentially could be exacerbated by program participation
assessment of the effects on barrier impairment, clinical features and bacterial colonization of topical formulations in patients with atopic eczema; a phase iia, single-center, randomized, observer-blind study

Conditions: Atopic Dermatitis

Summary: the purpose of the study is the assessment of the barrier impairment, clinical skin condition and bacterial colonization status in patients with atopic eczema following topical treatment with k201 cream and a comparator twice daily over a 4-week treatment period.


Eligibility criteria:
inclusion criteria: * signed written informed consent obtained; * male or female patients, 18 years or older; * manifest atopic eczema diagnosed according to hanifin and rajka; * two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting hanifin and rajka´s criteria; * tewl in the lesional areas at least 12 g/m²h, tewl value differences ≤ 30 % are allowed between both lesional areas; * the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; * sexually active females of childbearing potential should either be surgically sterile hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen:systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (iud), condom with intravaginal spermicide. exclusion criteria: * acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas; * suntan which in the opinion of the investigator prevents correct assessments * dark-skinned persons whose skin color prevents ready assessment of skin reactions; * evidence of drug or alcohol abuse; * pregnancy or nursing; * uv-therapy within 6 weeks before first treatment; * participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study; * symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; * known allergic reactions to components of the study preparation and the comparator; * treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (exception: asthma may be found in patients with atopic eczema,therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. the dosage should remain constant throughout the study period); * in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; * patient is institutionalized because of legal or regulatory order.
high-resolution ultrasound in lower extremity nerves and common fibular neuropathies.

Conditions: Ultrasonography; Peroneal Neuropathies

Summary: this study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. high-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

the usual diagnostic work-up of patients referred for lower-extremity neuropathy includes clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological assessment and if necessary nerve biopsy. the electrophysiological assessment usually consists of nerve conduction studies (ncs) and electromyography (emg). while electrophysiological measurements generally give information about the function of nerves, high-resolution ultrasound may provide information about the structure of nerves. high-resolution ultrasound examination has shown promising results as a supplementary tool in the diagnostic work-up of various peripheral neuropathies. the clinical utility of ultrasound in the diagnosis of common fibular neuropathies, however, calls for further elucidation. this study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls, as well as each other. high-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

Eligibility criteria:
inclusion criteria: * type 2 diabetes polyneuropathy common fibular nerve affection or * common fibular nerve compression neuropathy exclusion criteria: * lumbar radiculopathy * other competing lower extremity peripheral neuropathy * peripheral vascular disease * hypothyroidism

Keywords: ultrasound reference material sensitivity specificity common fibular compression neuropathy type 2 diabetes polyneuropathy intra-rater reliability inter-rater reliability
role of diffusion -weighted mri in evaluation of urinary bladder masses

Conditions: Urinary Bladder Neoplasm

Summary: urinary bladder cancer is a common malignant tumor of the urinary tract in both men and women. proper management of the urinary bladder cancer depends on the stage of the lesions. differentiating the histopathological types, tumor grade and the depth of tumor invasion are very important for determining the therapeutic approach and are highly correlated with the recurrence, progression and patient's survival. radical cystectomy (rc) and lymphadenectomy after neoadjuvant chemotherapy is the standard treatment for muscle invasive tumors, whereas the treatment of choice for non-muscle invasive tumors is transurethral resection (tur) ±chemo/immunotherapy. cystoscopy with biopsy is still the best tool for bladder cancer staging due to its high sensitivity in detecting lesions and the possibilities of tumor resections, but the main drawbacks are invasiveness, limitation in detection of flat lesions, and lack of the assessment of extra-vesical tumor invasion. modern diagnostic modalities circumvent these limitations like blue-light cystoscopic examination and infrared cystoscopy. for the radiological evaluation of the urinary bladder, magnetic resonance imaging (mri) is a valuable imaging modality due to high tissue contrast and multiplanar imaging capabilities. diffusion-weighted images provides useful information for evaluation of local t stage of the urinary bladder cancer, specially in differentiating t1 stage or lower tumors from t2 stage and higher tumor stages. apparent diffusion coefficient (adc) delineating the degree of water molecular diffusion and the degree of restriction to water diffusion in biological tissues is inversely correlated to the integrity of the cell membranes and the tissue cellularity. the apparent diffusion coefficient (adc) value has been revealed as quantitative measure of the degree of malignancy of the lesions. decreased adc values were reported with malignant lesions which have a larger cell diameter and more cellularity than normal tissue.


Eligibility criteria:
inclusion criteria :• age, any age will be included * sex, both genders are included. * patient presenting with heamaturia or intractable cystitis and urinary bladder mass lesions detected on ultrasound and/or ct examinations (with contrast). exclusion criteria: • general contraindications to mr imaging (pacemaker, metallic prostheses and clostrophobia).
mozzarella cheese vitamin d and bioavailability

Conditions: Change in Serum 25 Hydroxyvitamin D Levels

Summary: the purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin d in industrially fortified mozzarella cheese baked with pizza.

with a growing body of evidence, the institute of medicine (iom) conducted a thorough review of all available evidence to publish a report on dietary reference intakes (dris) for calcium and vitamin d. in the absence of adequate sun exposure, acquiring the new rda of 600-800 iu/d for vitamin d through diet alone is difficult. there is a need to increase dietary sources of vitamin d for canadians. in a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin d3 fortified mozzarella cheese. we tested the following hypotheses, set a priori: 1) vitamin d3 is bioavailable from pizza baked with fortified mozzarella cheese and heat does not significantly break down vitamin d3; and 2) the change in serum 25(oh)d (from baseline to 10 wk) will be significantly greater in the high-dose vitamin d treated group (28000 iu/wk) compared to the low dose vitamin d-treated group (200 iu/wk).

Eligibility criteria:
inclusion criteria: * healthy males and females between ages 18-70 years exclusion criteria: * use of vitamin d supplements in excess of 1000 iu/day * a history of any medical disorder that might effect vitamin d or mineral metabolism * use of medications that could interfere with vitamin d metabolism * potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study * history of hypercalcemia * unwillingness to return for follow up

Keywords: mozzarella cheese fortification bioavailability of vitamin d
comparing the safety and efficacy of paclitaxel controlled release balloon catheter (vasoguardtm) in the treatment of small coronary vessel stenosis with a common coronary balloon catheter (maverick2)

Conditions: Small Vessel Lesion

Summary: study purpose the safety and efficacy of paclitaxel controlled release balloon catheter vasoguardtm in treatment of small vessel lesion. study group experimental group: paclitaxel controlled release balloon catheter (vasoguardtm) control group: common balloon catheter (maverick2)


Eligibility criteria:
inclusion criteria: subject need 18 to 80 years of aged male or non-pregnant women; subject has stable anina pectoris, or unstable anina pectoris, or old myocardial infarction patients, or ischemia with evidence but without symptom; subject has a life expectancy of more than 2 years; lesion vessel reference diameter is less than or equal to 2.5mm, target lesion length is less than or equal to 40mm; target lesion stenosis is equal or greater than 70% or 50% and with ischemia; single or two coronary small vessel lesions in situ; subject can understand the trail purpose, sign informed consent voluntarily, agree to accept clinical telephone follow-up and angiographic follow-up at 9 months; target lesion can be pre-expanded successfully (guide wire can get through lesion, balloon pre-expand the remnant stenosis of vessel lumen is less or equal to 50%, without current limiting interlayer and thrombosis). exclusion criteria: patient that in the opinion of the investigator is not appropriate for this trail; pregnancy and lactation female patients; patient has a life expectancy of less than 2 years; severe congestive heart failure or nyha iv heart failure; patient who have bleeding constitution, cannot use antithrombotic and antiplatelet drugs; patient that happened acute myocardial infarction within a week; patient who happened stroke within six months; patient who with severe renal failure (gfr≤30ml/min); patient has received heart transplantation; patient who cannot tolerate aspirin and / or p2y12 receptor inhibitor drugs; patient who has allergy to paclitaxel, plga or contrast agent; peptic ulcer or gastrointestinal bleeding within the prior 6 months; patients who are participating in another drug or device clinical trail, which have not completed the primary endpoint follow- up period. angiographic relevant： merge three or more coronary small vessel lesions; target vessel with extensive thrombosis evidence; restenosis of vein graft after bypass surgery; target lesion proximal exist seriously distorted or severe calcified lesion.
effectiveness and cost impact of a telecommunications system in copd

Conditions: Lung Diseases, Obstructive

Summary: chronic obstructive pulmonary disease (copd) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. interventions that enhance symptom self-monitoring and increase understanding of copd therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. however, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. a novel means of providing such interventions is a telephone-linked computer (tlc) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. in previous studies, we have demonstrated the applicability of tlc technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia.

background: chronic obstructive pulmonary disease (copd) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. interventions that enhance symptom self-monitoring and increase understanding of copd therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. however, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. a novel means of providing such interventions is a telephone-linked computer (tlc) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. in previous studies, we have demonstrated the applicability of tlc technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia. objectives: the objectives of the study were to determine whether a telecommunications system for copd care (tlc-copd) leads to improvements in functional status and quality of life (qol) as well as to reductions in health care utilization and costs exceeding the tlc intervention. methods: the study was designed in the form of a randomized controlled trial involving subjects with copd who receive care at two boston-area va hospitals. subjects were assigned to either tlc-copd or a usual care control group. status: complete.

Eligibility criteria:
inclusion criteria: copd diagnosis; fev, \< _65% pred; fev, /fvc\<_85% pred exclusion criteria:
the effect of wild blueberry consumption on glucose regulation in healthy adults

Conditions: Diabetes

Summary: the objective of the study is to determine how wild blueberry consumption affects glucose regulation, gastrointestinal hormones and satiety in healthy adults.

healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized, placebo controlled crossover design study. subjects were screened to determine their health status (e.g. height, weight, body mass index, blood pressure and medical history). subjects were randomly assigned to a sequence of two treatments with two study periods. the treatments are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen wild blueberries. the subjects were asked to avoid high polyphenol foods in their typical diet for 7 days and consume one of the two treatments as a dietary intervention. after the seventh day subjects consumed a test meal along with either the wild blueberry or placebo. blood was collected to determine glucose and satiety hormone levels.

Eligibility criteria:
inclusion criteria: * male or female exclusion criteria: * bmi \ 30 kg/m² * pregnant women or women who plan on becoming pregnant during the study * postpartum women * lactating women * diabetes mellitus * kidney disease * liver disease * gi disease * certain cancers * smokers * blueberry allergies