Kornimate/medical-research-clean huggingface dataset:
hormone profiles in adults with newly diagnosed epilepsy

Conditions: Epilepsy

Summary: both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed epilepsy. although they appear to have similar efficacy, they have different side effects, which have not been well studied. this study aims to compare one particular aspect of their possible side effects, namely whether they affect certain hormonal functions.

sodium valproate is an established antiepileptic drug used against a broad range of seizure types. lamotrigine, a newer antiepileptic drug available since late 1980s, has a similar range of action and is approved as first-line treatment for epilepsy in the united states and many european countries as well as in hong kong. recently, concern has been raised over the association between valproate treatment and polycystic ovarian syndrome, a condition characterised by multiple cysts in the ovaries in women and a range of hormonal and metabolic disturbances. cross-sectional studies from finland suggest that up to 40% of women treated with valproate have polycystic ovaries. lamotrigine substitution for valproate has been reported to normalise these parameters in some patients. elevated serum insulin and androgen levels have also been reported in over 50% of male patients taking valproate for epilepsy. however, such high incidence of hormonal abnormalities associated with valproate treatment has not been reproduced in studies conducted in other western populations. no similar studies in chinese patients have been reported. in addition, these cross-sectional studies suffer from many potential confounding factors, such as previous treatment with other antiepileptic drugs, variation in duration of treatment, thus limiting the ability to establish a causal relationship. this phase iv study aims to examine whether valproate treatment is associated with hormonal abnormalities in chinese epilepsy patients. newly diagnosed patients will be randomised to receive valproate or lamotrigine and their hormonal profiles measured prospectively for 12 months.

Eligibility criteria:
inclusion criteria: * patients aged between 15 and 55 * ethnically chinese * newly diagnosed epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse. exclusion criteria: * post-menopausal women. * pregnant women. * women who have undergone oophorectomy. * women taking or have taken oral contraceptive pills in the previous 3 months. * women diagnosed with or suspected to have polycystic ovarian syndrome. * subjects with diabetes mellitus. * subjects receiving hormone replacement or glucocorticoids. * subjects receiving long-term warfarin. * subjects suffering from significant systemic diseases, or illnesses that interfere with pituitary-gonadal functions. * subjects with a progressive or degenerative neurological disorder. * subjects who are unable to take their medication reliably.

Keywords: epilepsy hormone
respiratory-swallow coordination in cardiothoracic surgical patients

Conditions: Thoracic Diseases; Cardiovascular Diseases

Summary: dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (cs). although alterations in respiratory-swallow coordination is a known underlying pathophysiologic mechanism of dysphagia in multiple patient populations, no group has examined respiratory-swallow physiology in cs patients. the proposed study will examine respiratory-swallow physiology in cs patients and determine its association with unsafe swallowing and inferior health-related outcomes.

the proposed study will examine respiratory-swallow physiology in cardiothoracic surgical patients and determine its association with unsafe swallowing and inferior health-related outcomes. participation will involve a single postoperative research exam of approximately 60-90 minute duration. participants will be seated upright and positioned for simultaneous instrumental imaging of swallow physiology, nasal airflow monitoring, and respiratory inductance plethysmography testing.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age who have undergone cardiothoracic surgery at uf health * no allergies to barium * not pregnant * willing to participate in study exclusion criteria: * individuals 18 years of age or younger * allergies to barium * pregnant * not willing to participate in study

Keywords: dysphagia extubation respiratory-swallow coordination swallow
a clinical trial to evaluate the efficacy and safety of agnucaston tablets in the treatment of premenstrual syndrome (pms)

Conditions: Premenstrual Syndrome

Summary: to compare the efficacy and safety of agnucaston tablets with placebo for the treatment of premenstrual syndrome (pms) and assess if agnucaston tablets are superior to placebo on efficacy or not.

premenstrual syndrome (pms) is a common disorder in women and consists of somatic and/or behavioral/mood symptoms, which can impair a woman's social and work-related functioning. some clinical studies with preparations containing vitex agnus castus have demonstrated a positive effect on pms with good tolerability. the aim of this clinical trial is to investigate the efficacy and safety of agnucaston tablets for the therapy of pms.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pms disease * age between 18 and 45 years * patients is in general good health exclusion criteria: * any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor. * clearly kidney or liver disease, abnormal kidney or liver function. * any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma. * prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.

Keywords: premenstual syndrome, pms, clinical trial
relaxation-response-based mental health promotion - open and calm 2013

Conditions: Stress Psychological; Stress Physiological; Quality of Life

Summary: the purpose of the study is to investigate health-promoting and stress-reducing psychological, physiological and hormonal effects of a 9-week meditation-based course in personal health and to examine potential baseline factors for any such effects. thus, the investigators will investigate the course format (individual course or group-based course) as a potential factor the course outcome, and also individual background factors such as demographics and genetic variations.


Eligibility criteria:
inclusion criteria * experience of stress, defined as a cohen's perceived stress scale score \> 12. * speaks and reads danish fluently. * ability to use the internet to complete questionnaires. * participation in face-to-face study information meeting. * signed agreement to the study conditions and informed consent form exclusion criteria * other current treatment (psychological, medical or other) for stress, depression, anxiety, phobias, traumas or other psychological problems. * other current treatment for bodily illnesses, such as pain, migraine, cancer. * more than one diagnose with psychiatric disease (e.g. anxiety, depression) within the past 3 years. * body-mass index \> 30. * major depression inventory score \> 25 at inclusion interview. * physical handicaps affecting life stress or quality of life chronically. * drug use (\> 50 times hash during the past two years; max 20 times harder drugs, max 2 times per month since the 18th birthday on average; no periods \> 3 years where the use of drugs exceeded two times per month). * alcohol use \> 21 drinks/week for men, and \> 14 drinks/week for women and audit-scores (a scale of alcohol-related problems) \>20. * serious head trauma.

Keywords: health promotion prevention relaxation response meditation cortisol
role of neuraminidase activity on endothelial dysfunction in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in t2d patients.

twenty subjects will complete five days of treatment with zanamivir. baseline measurements will be taken before the initiation of treatment, as well as after the conclusion of the treatment period (i.e., a total of two assessment visits per subject). assessment visits will include: vitals (such as blood pressure, heart rate), fasting blood work for plasma neuraminidase activity, plasma sialic acid, plasma glucose and plasma insulin, brachial artery fmd, and glycocalyx integrity assessment via glycocheck.

Eligibility criteria:
inclusion criteria: 1. men and women with a bmi of 25-39 kg/m2 2. ages 45-64 years at randomization. 3. diagnosis of t2d classified based on physician diagnosis. 4. no vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled. exclusion criteria: 1. cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke 2. history of chronic renal or hepatic disease 3. active cancer 4. autoimmune diseases 5. immunosuppressant therapy 6. hormone replacement therapy 7. excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women) 8. current tobacco use 9. pregnancy (premenopausal women will be required to complete a urine pregnancy test before participation) 10. history of asthma or chronic obstructive pulmonary disease. 11. history of allergic reaction to lactose or milk proteins 12. intranasal live attenuated influenza vaccine (laiv) given within 2 weeks before zanamivir administration or a planned dose within 48 hours after zanamivir administration. product insert states to avoid zanamivir administration with intranasal live attenuated influenza vaccine (laiv).

Keywords: endothelial dysfunction vascular function glycocalyx integrity assessment
fecal dna methylation detection for gastric cancer

Conditions: Gastric Adenocarcinoma

Summary: the study is a prospective, multicentre, cross-sectional study to evaluate the efficacy of fecal methylation-based testing in comparison with the 'gold standard' imaging tests, such as ct, gastroscopy and/or pathology, for the prediction of gastric cancer in an enrolled population.

aims of the study primary study aim: to assess the sensitivity and specificity of fecal methylation site-based tests for the prediction of gastric cancer. secondary research objectives: 1. the accuracy, kappa value, area under the roc curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as ca19-9, cea, and ca72-4, etc.; 3. the predictive ability of the combined fecal h. pylori gastric cancer susceptibility test was assessed. study design prospective, multicentre, cross-sectional study. study period 2 years from the start of the project as approved by the institutional ethics committee. target population the target population is over 40 years old in areas with a high incidence of gastric cancer. sample size the sample size of this study should not be less than 10,800 cases.

Eligibility criteria:
inclusion criteria: * age ≥40 years, male or female. * have or will have gastroscopy and/or pathology results. * no contraindications to endoscopy and able to cooperate with endoscopy. * patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person. exclusion criteria: * have severe cardiac, hepatic, or renal insufficiency, or mental disorders. * previous history of upper gastrointestinal malignancy. * women during pregnancy. * those with unspecified pathology.
inspiratory muscle training in children with chest burn

Conditions: Burns; Respiratory Function Impaired; Children

Summary: 8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.

the primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.

Eligibility criteria:
inclusion criteria: * children aged 10 to 18. * following hospital discharge.- total body surface area (tbsa) of 30% to 50%. * chest burns. * deep partial to full thickness burns. * subjects who had a skin graft or who healed completely were also included. exclusion criteria: * - participants who had a nonhealing or open wound. * congenital diaphragmatic hernia. * chest wall deformity. * cardiac or pulmonary problems.

Keywords: chest burn respiratory muscle strength lung function
effects of an individualized training program on severity markers of obstructives sleep apnea/hypopnea syndrome (osas)

Conditions: Sleep Apnea, Obstructive; Exercise Training Therapy

Summary: there are two types of treatments depending on the severity of obstructive sleep apnea/hypopnea syndrome (osas): - for the treatment of severe (ahi\> 30/h), the standard treatment is continuous positive airway pressure (cpap). if it proved effective in reducing excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4 years of treatment falls below 70%. - treatment of moderate (ahi between 15 and 30/h), lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck surgery can be proposed. these treatments include side effects and their effectiveness is very controversial.il therefore seemed interesting to test the impact of physical activity through a standardized training program to re personal effort on the development and improvement of osas patients with a sedentary moderate to severe osas (ahi between 15 and 40 / h) the main assumption is that the esr could eventually delay the initiation of treatment with cpap in severe osas or an alternative therapeutic relevance in the moderate osas and severe in patients who can not tolerate conventional treatment(csf). the main objective of this biomedical research is to evaluate the effects of a program of ree in ambulatory index of hourly apneas / hypopneas (ahi = marker of severity of osas) .- objectives specify 2air effects of ree on the quality of sleep (txslp) and daytime symptoms (eds objective fatigue) on the one hand and the other on the metabolism (ov, sm, ir) and markers of lcr (inflammation, oxidative stress , endothelial function).


Eligibility criteria:
inclusion criteria: * presence of an osas * apnea hypopnea index between 15 and 45/h * sedentary subjects (voorips activity questionnaire) * imc\<40

Keywords: obstructive sleep apnea/hypopnea syndrome exercise training program inflammation oxidative stress insulin resistance
long-term exposure to rizatriptan 5-mg and 10-mg oral tablet (combined extension protocols mk-0462-022, mk-0462-025, mk-0462-029)

Conditions: Migraine Disorders

Summary: this record describes pooled data for three extension studies: mk-0462-022 (nct00897949); mk-0462-025 (nct00899379); and mk-0462-029 (nct00897104). these studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.


Eligibility criteria:
inclusion criteria: * participant took part in study mk-0462-022, mk-0462-025, or mk-0462-029 * history of migraine headache

Keywords: migraine headache
the impact of the glycaemic index (gi) on daily blood glucose profiles and food intake in young chinese adult males

Conditions: Type 2 Diabetes; Obesity; Prediabetes

Summary: this study is carried out to find out the inclusion of high and low glycaemic index (gi) foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.

the gi is a method of classifying foods based on the food's ability to raise the blood glucose level. low gi foods are recommended as they have a lower impact on blood glucose concentrations and also reduce total food intake. there is very little information on how eating high and low gi foods affect daily blood glucose concentrations in asians. therefore, the objective of this study is to observe the effect of eating high and low gi breakfasts and snacks on 24 hour blood glucose concentrations and food consumption in asian males. healthy, normal-weight, chinese males will be recruited. there will be two sessions (consisting of four days for each session) where they will consume either a high or low gi breakfast or snack, and a standardized ad libitum lunch buffet. their glycaemic response will be measured using a continuous glucose monitoring system (cgms) throughout the period. the proposed research for the first time demonstrates how the consumption of high and low gi breakfasts and snacks affect subsequent energy intake and 24 hour blood glucose profiles in asians. these findings will have significant public health benefits for optimum weight and dietary control.

Eligibility criteria:
inclusion criteria: * chinese, male * age between 21-40 years * body mass index between 17 to 24 kg/m2 * normal blood pressure (120/80 hgmm) * fasting blood glucose \< 6 mmol/l exclusion criteria: * having any metabolic diseases (such as diabetes, hypertension etc) * one prescription medication * partaking in sports at the competitive and/or endurance levels * allergic/intolerant to any of the test foods * intentionally restricting food intake * smoking
comparison of contrast agents in liver mr for the detection of hepatic metastases

Conditions: Oligometastatic Disease; Liver Metastases; Colorectal Cancer

Summary: if an abbreviated hbp protocol liver mr with gadobenate dimeglumine is shown clinically comparable to standard of care liver mr with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

the goal is to: * estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (auroc), of abbreviated protocol liver magnetic resonance (mr) with hepatobiliary phase (hbp) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver mr with hbp using gadoxetate disodium, 2) standard of care complete protocol liver mr using gadoxetate disodium, and 3) complete protocol liver mr using gadobenate dimeglumine. * estimate and compare quantitative measures of hbp images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios \[cnr and snr\]) for both gadobenate dimeglumine and gadoxetate disodium. * qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver mr with hbp using gadobenate dimeglumine versus abbreviated protocol liver mr with hbp using gadoxetate disodium.

Eligibility criteria:
inclusion criteria: * colorectal cancer patients * age 18-80 years * no prior treatment including surgery * prior imaging with suspected liver metastasis exclusion criteria: * age \ 80 years * egfr \< 30 ml/min/1.73 m2 * previous reaction to gadolinium contrast agents * history of claustrophobia or movement disorders likely to impact image quality * non-mr safe implants or metallic foreign bodies
exercise capability and training effects in diabetic patients with neuropathy

Conditions: Diabetes Mellitus; Peripheral Neuropathy

Summary: the purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. furthermore, to search the possible underlying mechanisms.


Eligibility criteria:
inclusion criteria: * type 2 diabetes with neuropathy. exclusion criteria: * central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.

Keywords: diabetes mellitus peripheral neuropathy exercise balance performance
t-cell response in patients receiving trastuzumab and/or chemotherapy for her2-positive solid tumors

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. it may also help the study of cancer in the future. purpose: this laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for her2-positive solid tumors to assess t-cell response.

objectives: * assess t-cell activation in blood samples of patients receiving trastuzumab (herceptin®) and/or chemotherapy for her2-positive solid tumors. outline: blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (herceptin®)/chemotherapy. patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen. blood samples are examined for t-cell proliferation and intracellular cytokine production. cd8 t-cell response, her2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of solid epithelial tumor, including, but not limited to, the following: * breast cancer * ovarian cancer * lung cancer * uterine cancer * prostate cancer * her2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization * must be receiving trastuzumab (herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine) patient characteristics: * absolute neutrophil count \> 1,000/mm\^3 * absolute lymphocyte count \> 400/mm\^3 * platelet count \> 90,000/mm\^3 * hemoglobin \> 8 g/dl prior concurrent therapy: * no other chemotherapy within the past 4 weeks

Keywords: unspecified adult solid tumor, protocol specific stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer male breast cancer recurrent breast cancer stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer recurrent ovarian epithelial cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer recurrent prostate cancer stage i uterine sarcoma stage ii uterine sarcoma stage iii uterine sarcoma stage iv uterine sarcoma recurrent uterine sarcoma