Kornimate/medical-research-clean huggingface dataset:
dietary choice in active older adult women

Conditions: Exercise Addiction; Diet Habit; Obesity; Overweight; Weight Loss

Summary: the present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

background: negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. objectives: the present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain. material and methods: participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). they were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. of all 111 participants, 90 persons completed the treatment. the weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria:
inclusion criteria: non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study. exclusion criteria: history of cvd and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. subjects with abnormality in thyroid or electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Keywords: diet exercise obesity overweight weight loss
escitalopram and sleep architecture in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design. hypothesis: escitalopram will improve rem latency in patients with mdd that have responded clinically to treatment.

disturbance of sleep is a prominent symptom in depressive disorders. alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. polysomnographic recordings have confirmed these reports, reporting reduced latency of the first rem episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of rem sleep, a reduction of deep slow wave sleep (sws) and increase in night awakenings (benca et al., classification of sleep disorders). the effects of antidepressant drugs on depression and sleep disorders, specifically ssris, have been thoroughly researched. the effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design. hypothesis: escitalopram will improve rem latency in patients with mdd that have responded clinically to treatment.

Eligibility criteria:
inclusion criteria: * patients suffering from mdd, excluding a depressive episode of bipolar disorder. * the depressive episode is not secondary to a general medical condition or substance abuse. * ages between 18-65 years old. * patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics. * able to understand and sign an informed consent form. exclusion criteria: * patients suffering from sleep disturbances due to a physical condition (copd, sleep apnea or essential insomnia preceding the diagnosis of depression). * patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary). * patients suffering from a malignancy or neuro-degenerative such as parkinsons' disease * patients suffering from a clinically significant psychiatric psychotic disease, as judged by dsm-iv criteria, such as schizophrenia or acute psychosis. * patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase. * history of drug or alcohol dependence within the last year.

Keywords: mdd escitalopram cipralex sleep rem sws polysomnography
parenteral antibiotics compared to combination of oral and parenteral antibiotics in colorectal surgery prophylaxis

Conditions: Surgical Wound Infection

Summary: routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. experimental group: patients undergoing elective colorectal surgery that involves, colonic resection. the antibiotic prophylaxis in this group will be composed of: an oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. + control group: patients undergoing elective colorectal surgery that involves, colonic resection. the antibiotic prophylaxis in this group will be composed of: an intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. in both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. there won´t be a placebo treatment. subject compliance will be evaluated according to the usual practice in surgical care field


Eligibility criteria:
inclusion criteria: * patients presenting colonic pathology * the surgery is not contraindicated * diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..) * indication of segmentary resection or total colectomy * patients who agree to participate voluntarily in the study and signed an informed consent. exclusion criteria: * patients who refuse to participate in the study. * patients undergoing mechanical colon preparation the day before surgery. * patients with rectal cancer * patients with intra-abdominal sepsis before surgery (abscess, diverticulitis). * patients who received preoperative antibiotics for any reason in the two weeks prior to surgery. * patients with inflammatory bowel disease (ulcerative colitis, crohn's disease and indeterminate colitis) * patients presenting allergy to the drugs under study. * patients that will not strictly follow the assigned prophylaxis regimen * patients undergoing urgent surgery (\<24h)

Keywords: postoperative wound infection surgical wound infection colorectal surgery infection prophylaxis
an observational study of botox® as headache prophylaxis for chronic migraine

Conditions: Migraine Disorders

Summary: this is an observational study to describe the long term use of onabotulinumtoxin a (botox®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. all treatment decisions lie with the physician.


Eligibility criteria:
inclusion criteria: - prescribed botox® for the prophylaxis of headaches. exclusion criteria: * received treatment with any botulinum toxin type a serotype in the last 26 weeks * current participation in allergan's botox chronic migraine post-authorisation safety study (protocol 191622-110).
levels of anti-mullerian hormone (amh) during ovarian stimulation with gonadotropins

Conditions: Female Infertility

Summary: anti-mullerian hormone (amh) is produced only in small ovarian follicles with quite stable levels during the cycle. there is not yet sufficient data to inform couples undergoing ivf about the effect of ovarian stimulation on the levels of amh due to the increasing size of follicles and chances of success of the method.

patients undergoing ivf will be included in the study. all patients will be counseled regarding their prognosis. anti-mullerian hormone (amh) will be measured prior to the initiation of ivf and during ovarian stimulation. patients will be stimulated with a short gnrh-antagonist protocol. all women will have measurements of serum fsh and estradiol (e2) and a pelvic sonogram on the second day of their cycle. ovarian stimulation will be initiated with of gonadotropins either in the form of a combination of highly purified urinary fsh and lh or with a combination of rec fsh and rec lh. the dose of gonadotropins will depend on the levels of estradiol and fsh prior stimulation. all patients will be re-evaluated on day 3 and 5 of the stimulation (measurment of amh, e2 and pelvic sonogram), and dosage adjustments will be made and the antagonists (cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5. measurment of amh, e2 and pelvic sonogram to conferm the size of follicles will be continue every second day untill the oocyte retrieval. when at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000iu of hcg ( pregnyl, organon, greece inc.). oocyte retrieval will be performed 34 to 36 hours later. patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

Eligibility criteria:
inclusion criteria: * all infertile women undergoing ovarian stimulation for ivf. exclusion criteria: * women who can not undergo ivf

Keywords: amh ivf ovarian stimulation
dextenza within upper lid canaliculus compared with lower lid canaliculus following bilateral cataract extraction surgery with pciol.

Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation

Summary: assessing dextenza efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

randomized controlled clinical trial assessing the efficacy of dextenza, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (ce/pciol).

Eligibility criteria:
inclusion criteria: * been diagnosed with clinically significant cataract and ce/pciol has been planned * bilateral cataract surgery with iol has been planned * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * obstructed nasolacrimal duct in the study eye(s) * hypersensitivity to dexamethasone * patients being treated with immunomodulating agents in the study eye(s) * history of prior ocular surgery, excluding lasik or prk * history of ocular inflammation or macular edema * use of any systemic nsaids greater than 375 mg per day * patients being treated with immunosuppressants and/or oral steroids * patients with a corticosteroid implant (i.e. ozurdex) * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Keywords: dexamethasone cataract capsule opacification inflammation lens diseases eye diseases anti-inflammatory agents
carisbamate safety study in adult and pediatric subjects with lennox-gastaut syndrome

Conditions: Lennox Gastaut Syndrome

Summary: open-label extension study from ykp509c001 to evaluate the safety and tolerability of carisbamate in subjects with lennox-gastaut syndrome (lgs).

subjects who successfully completed the ykp509c001 study and could benefit from continued exposure to carisbamate. this is an open-label (ol), multi-center study of carisbamate in subjects with lgs, with safety assessments from baseline (visit 1) through the early termination (et)/end of study (eos) visit.

Eligibility criteria:
inclusion criteria: * subjects who completed the ykp509c001 study * investigator believes subject could benefit from continued exposure to study drug * subjects must continue to meet all of the inclusion criteria from the ykp509c001 study exclusion criteria: * subjects must continue to not meet any of the exclusion criteria from the ykp509c001 study * there are no additional exclusion criteria in this study
medical imaging of cachexia

Conditions: Cancer Cachexia

Summary: this is a pilot trial using 18f-fdg pet and dxa scans to determine whether these investigations are objective tools to assess cachexia.

this pilot study will establish the differences in bat uptake of 18f-fdg in cachectic and non-cachectic cancer patients using pet imaging. patients willbe assessed for sarcopenia using a dual energy x-ray absorptiometry or bone densitometry scan (dxa). given the variables which may affect uptake of bat in cancer patients, this study will standardise patient preparation and pet scan procedure in order to obtain the most reliable assessment of bat activity in all patients on study. it is hypothesisd that use of this pet imaging technique, which is part of standard care to assess cancer progression, may assist clinicians in early identification of metabolic changes in a patient, with potential for early intervention and utility in monitoring success of treatments of cachexia. a total of 40 patients will be evaluated, 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (nsclc) or pancreatic cancer without cachexia, and 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (nsclc), or pancreatic cancer with documented cachexia, all of whom are referred for standard of care 18f-fdg pet scans.

Eligibility criteria:
inclusion criteria: * patients with malignant disease; * ecog performance score of 0-2; * age ≥ 18 years; * life expectancy of \>4 months at screening; * cachexia patient group only: fulfils diagnostic criteria for cachexia: unintentional weight loss more than 5% over the previous 6 months, or more than 2% in individuals with a decreased body-mass index of \<20kg/m2, or skeletal muscle wasting (sarcopenia). exclusion criteria: patients with uncontrolled diabetes mellitus; * psychological unstable persons presumed unfit to perform the investigations; * persons unable to lie or sit still for 1-2 hours; * pregnant patients; * patients who received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history limiting nutritional intake; * patients who are receiving any chemotherapeutic agents which is limiting nutritional intake; * persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves; * the use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (mao inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).

Keywords: 18f-fdg pet scan dexa scan quality of life assessment tools
a pharmacokinetic study of cj30001 and hkb0701/slm0807 in healthy subject

Conditions: Diabetes Mellitus

Summary: the objective of this study is to demonstrate the bioequivalence of cj30001(fixed-dose combination tablet of hkb0701 and slm0807) relative to hkb0701 and slm0807 co-administered to healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. ideal weight = \[height -100\]\*0.9 * subjects with no history of any significant chronic disease * judged to be in good health on the basis of their vital sign, ecg, physical exam and routine laboratory data * available for the entire study period * willing to adhere to protocol requirements and sign a informed consent form exclusion criteria: * subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration * subjects who have symptom of an acute illness within 4 weeks prior to drug administration * subjects with a history of clinically significant allergies including drug allergies * subjects whose clinical laboratory test values are outside the accepted normal range(especially,ast or alt \>1.25 times to normal range or total bilirubin \> 1.5times to normal range) * subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day) * subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration * heavy smoker ( \>10cigarettes/day) * subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) * subjects who have donated plasma within 60days prior to drug administration * subjects who have participated in a clinical study within 90days prior to drug administration * subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration) * female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
the use of international ovarian tumor analysis and assessment of adnexal neoplasia in differentiating malignant and benign adnexal masses

Conditions: Adnexal Mass

Summary: all participants will be subjected to serum measurements of ca-125 by the immunoradiometric assay, ultrasound evaluation of the adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. then surgical intervention will be done with pathological examination of the specimen

all participants will be subjected to serum measurements of ca-125 by the immunoradiometric assay, ultrasound evaluation of the adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. then surgical intervention will be done with pathological examination of the specimen

Eligibility criteria:
inclusion criteria: * women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. patients who will undergo surgical intervention . 3. patients are recruited regardless of age, parity and complaint exclusion criteria: * patients treated with conservative management. 2. patients known to be pregnant.
efficacy of bipams for restless legs syndrome in adults with multiple sclerosis: a pilot study

Conditions: Multiple Sclerosis; Restless Legs Syndrome

Summary: the purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (rls) severity in persons with multiple sclerosis (ms) and rls. the study includes a proposed sample of 20 persons with ms and rls that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.

the primary aim of the proposed pilot rct involves examining the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing rls severity in persons with ms and rls. secondarily, the investigators will be assessing changes in sleep quality and daytime sleepiness following the behavioral intervention. the study includes a proposed sample of 20 persons with ms and rls that will complete a baseline testing session for measures of physical activity, restless legs syndrome severity, sleep quality, and daytime sleepiness. participants will then be randomized into one of two study arms: (1) a 16-week social cognitive theory-based behavioral intervention aimed at increasing physical activity; or (2) 16-week waitlist control with the option of completing the intervention upon completion of the study. all participants will complete a follow-up testing session at the conclusion of each 16-week arm.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * relapse free in the past 30 days * positive screen for restless legs syndrome * non-active (not engaging in 30 minutes of activity per day on more than 2 days per week in the previous six months) * ambulatory without assistance * internet and email access exclusion criteria: * diagnosis of radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia) renal disease, or diabetes * screen at moderate or high risk for undertaking strenuous or maximal exercise

Keywords: physical activity