Kornimate/medical-research-clean huggingface dataset:
bridging study of l059 (levetiracetam) in patients with epilepsy by double blind method

Conditions: Epilepsy

Summary: double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult japanese epileptic subjects with partial onset seizures.


Eligibility criteria:
inclusion criteria: * simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit; * seizures classifiable according to the ilae classification; * minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ; * exposed to two or more standard aeds; * taking up to three of the standard aeds, at the initiation of the trial. exclusion criteria: * medication influencing the cns, except for medication taken for antiepileptic treatment; * partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit; * history of cerebrovascular disease including transient ischemic attack (tia) and progressive cerebral disorder or progressive neurological disorder; * presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Keywords: levetiracetam keppra
the efficacy of tcd following by tp maintenance therapy in newly diagnosed wm

Conditions: Waldenström Macroglobulinemia

Summary: the purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.

enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.

Eligibility criteria:
inclusion criteria: 1. aged \>=18 years 2. diagnosed with wm 3. untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib 4. symptom patients 5. with life-expectancy more than 3 months. exclusion criteria: 1. diagnosed with other malignancies outside b-nhl within one year(including active centre neural system lymphoma) 2. transformed lymphoma 3. liver or renal function lesion unrelated to lymphoma 4. serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician 5. hiv positive or active hbv infection or other uncontrolled systematic infection 6. clinical central nervous dysfunction 7. serious surgery within 30 days 8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.
safety and efficacy of hypothermia to treat neonatal hypoxic-ischemic encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: the purpose of this study is to investigate the effectiveness and safety of selective head cooling (shc) in neonatal hypoxic-ischemic encephalopathy (hie).

hypoxic-ischemic encephalopathy (hie) remains a major cause of neonatal death and long term disabilities. data from animal studies have shown protective effects of mild hypothermia to both the mature and immature brain. recently research priorities have moved from bench to bedside. several studies have shown a trend for brain protection of mild to moderate hypothermia and mild hypothermia has emerged as a promising treatment for hie. therefore,the investigators organized a multi-centered randomized controlled trial of selective head cooling (shc) combined with mild systemic hypothermia in hie newborn infants.

Eligibility criteria:
inclusion criteria: * age up to 6 hours * gestational age ≥ 36 weeks and birth weight ≥ 2500 g * apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas ph \< 7.0 or base deficit ≤ 16 mmol/l, and/or need for resuscitation or ventilation at 5 minutes of age * clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc) exclusion criteria: * major congenital abnormalities * infection * other etiology of induced brain injury * severe anemia (hb \< 120 g/l) eligible infants assessed for the severity of hie according to criteria of the neonatal association of chinese academy of pediatrics 25 modified from sarnat and sarnat 26 in 1986

Keywords: hypothermia neonate hypoxic-ischemic encephalopathy efficacy safety
effect of exercise on chocolate addiction

Conditions: Acute Exercise and Addictive Behavior

Summary: the study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.

the purpose of this research study is to investigate whether a single high intensity interval exercise (hiie) bout, following two stress-inducing tasks, reduces addictive behavior to chocolate. volunteers must complete the consent form before being able to participate in two days of testing (exercise day and control day) which will be presented in randomized order. the two days will be separated by a one to 7 day washout period. subjects will be required to submit a three day chocolate diary then abstain from chocolate on the 4th day. they will also be asked to record everything they eat and drink on the day before and the morning of the study and list three types of chocolate they crave most. two stress-inducing tasks will be performed on both days followed by completion of either 26 minutes of hiie or seated resting condition followed by the completion of two mood and craving questionnaires. they will finally be asked to complete a task that measures the amount of attention they pay to chocolate. statistical analyses will be conducted to determine the effect of either exercising or not on addictive behaviors to chocolate.

Eligibility criteria:
inclusion criteria: * bmi equal or greater than 25 * eat at least 3.5 oz of chocolate per day * scorer at least 33 out of a possible 36 on the handedness questionnaire * ability to provide informed consent * no medical contraindications to exercise * premenopausal exclusion criteria: * pms * pregnancy * prisoners * risk factors for heart disease as determined by physician * medication that interferes with capacity to exercise * answer "yes" to par-q
back to the future: bridging the hospital to home continuum after hip fracture

Conditions: Hip Fracture

Summary: the purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.

the investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture. the primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults. in parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.

Eligibility criteria:
inclusion criteria: * adults (men and women) over 60 years of age * fall related hip fracture * community dwelling * english speaking exclusion criteria: * dementia * medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.) * profound hearing loss

Keywords: femoral fractures hip fractures frail older adults quality of life feasibility studies
effect of enhanced counseling using complementary feeding recommendation based on linear programming on nutritional status,omega-3 fatty acids, malondialdehyde, and alpha-tocopherol in overweight children in east jakarta

Conditions: Complementary Feeding Recommendation; Linear Programming,; Nutritional Status; Omega-3 Fatty Acids; Malondialdehyde; Alpha-Tocopherol; Overweight

Summary: the epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 diabetes mellitus and heart disease. currently, dietary and exercise changes are still the center of preventive and treatment measures of obesity. recently, the omega-3 group, one of the groups of polyunsaturated fatty acids (pufas), has been associated with many positive effects leading to the improvement of many diseases related to obesity. nevertheless, the consumption of this essential nutrient requires certain ration to optimize its favorable result. although previous studies have examined the efficacy of dietary counseling approach as treatment for obesity, none of them as explicitly explore the use of linear programming to create a tailored diet containing high omega-3 fatty acid food as a part of dietary counseling in obesity management program among children. thus, this study is intended to contribute the clinical evidence regarding this area of knowledge, specifically the effects of enhanced counseling containing complementary feeding recommendation on nutritional status, omega-3 fatty acid, malondialdehyde, and alpha tocopherol among children with risk of overweight aged 12 -23 months in east jakarta.

randomized-controlled-trial with two arms of intervention: 1. control group: receive standard counseling with general existing menu recommendation 2. intervention group: receive enhanced counseling (additional information on omega-3 fatty acids) with population-based menu ganerated from linear programming (lp) there is a protocol on stratified block randomization. 2 blocks, stratified by: area, age, bmi-for-age status. total sample size for analysis: overall: 20 control - 18 intervention blood sample: 18 control - 14 intervention

Eligibility criteria:
inclusion criteria: * aged 12-23 months old at first counseling * body mass index more than +1 standard deviation in who z-score * parent agree to participate in the study by signing informed consent exclusion criteria: * children with congenital disease and serious diseases * children with parent/caregiver who is illiterate * children with parent/caregiver who had communication disability

Keywords: complementary feeding recommendation linear programming nutritional status omega-3 fatty acids malondialdehyde alpha-tocopherol
pathogenesis and mechanisms of mitral annular calcification

Conditions: Mitral Annulus Calcification

Summary: researchers are testing blood or mitral valve tissue to better understand the reasons why mitral annular calcification (mac) develops in patients with heart disease.

the aim is to test the hypothesis that endothelial progenitor cells osteoblastic phenotype (epc-ocns) play a significant role in the process of mitral annular calcification (mac) as prognostic markers of calcific cardiac valves.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of mac and patients coming to the valve clinic without mac diagnosis patients who will undergo surgery, either standard surgical mvr or trans-atrial tmvr, with diagnosis of mac or without diagnosis of mac exclusion criteria: * subjects unwilling to participate or to provide consent
study to test the safety of hpv vaccine in women (v501-011)(completed)

Conditions: Cervical Cancer; Genital Warts

Summary: the primary purpose of the study is to test the safety of hpv vaccine in women


Eligibility criteria:
inclusion criteria: * females age 16 to 23 years old * must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit exclusion criteria: * history of vaccination with an hpv vaccine * history of hepatitis b infection * history of vaccination with hepatitis b vaccine * history of genital warts or treatment for genital warts
health status of patients after surgically implanted biological and mechanical aortic valves: a population-based retrospective analysis (2010-2018)

Conditions: Aortic Valve Disease

Summary: the overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in austria for the years 2010-2018.

the purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. we aim to compare those outcomes between mechanical valves and bioprostheses. data will be retrieved from the main social security carriers in austria (covering 98% of its population) from 2010-2018.

Eligibility criteria:
inclusion criteria: * isolated surgical aortic valve replacement in austria exclusion criteria: * below 18 years of age * concomitant heart surgery
motivational interviewing in physiotherapy for patients with low back pain

Conditions: Motivational Interviewing

Summary: this study aims to evaluate the efficacy of motivational interviewing (mi) on adherence to exercises and on levels of pain and incapacity in patients who engage in physiotherapy for low back pain. sixty patients attending a 15-day program of physiotherapy for low back pain were allocated to experimental (eg) and control groups (cg). a regular treatment of physiotherapy with at-home exercises is offered to all participants. on day seven, mi is applied to the eg. the cg receives an anti-inflammatory information program.


Eligibility criteria:
inclusion criteria: * adults with low back pain receiving physiotherapy with home exercises exclusion criteria: * adults receiving physiotherapy without home exercises or for conditions other than low back pain
intermittent fasting following acute ischemic stroke

Conditions: Ischemic Stroke; Intermittent Fasting

Summary: despite numerous kinds of evidence on functional health and cns protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. the aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.

in order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain mri / ct) patients will be randomly assigned to intermittent fasting group or control group. in both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. the intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. the efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.

Eligibility criteria:
inclusion criteria: * patients who was diagnosed first ischemic stroke within preceeding 1 year through brain mri/ct exclusion criteria: * musculo-skeletal disease with limbs malformation or joint contracture * weigh more than 135 kg or taller than 195 cm * diabetes mellitus * unstable patient in neurology * refusal of participation
hyperbaric oxygen therapy effects on pulmonary functions

Conditions: Oxygen Toxicity; Hyperoxia

Summary: prospective analysis included patients, 18 years or older, scheduled for 60 daily hbot sessions between 2016-2018. each session was 90 min of 100% oxygen at 2 ata with 5 minutes air breaks every 20 min, five days per week. pulmonary functions,measured at baseline and after hbot,included forced vital capacity (fvc), forced expiratory volume in one second (fev1), peak expiratory flow rate (pef).

after signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. participants were treated in a multiplace chamber (haux-life-support gmbh) for 60 daily sessions, 5 days a week. each session consisted of 90 minutes of exposure to 100% oxygen at 2 ata with 5 minute air breaks every 20 minutes. participants repeated their pulmonary function evaluation after the last hbot session. pulmonary function measurements of pulmonary functions were performed using the minispir testing apparatus (mir- medical international research, usa). the equipment was calibrated using a 3-liter syringe before performing measurements according to the manufacturer's instructions. measurements were performed by a trained technician. the forced expiratory maneuvers were performed as recommended by the guidelines\[13\]. the forced vital capacity (fvc), forced expiratory volume in one second (fev1) and peak expiratory flow rate (pef) were taken as the highest readings obtained from at least three satisfactory forced expiratory maneuvers. mean forced mid-expiratory flow rate (fef25-75%) and forced expiratory flow rates at 25, 50 and 75% of fvc expired (fef25%, fef50% and fef75%) were taken as the best values from flow-volume loops not differing by \>5% from the highest fvc.

Eligibility criteria:
inclusion criteria: * 18 and older patients * scheduled for 60 hbot sessions for any indication exclusion criteria: * active smokers were excluded but patients who quit smoking more than six months prior to inclusion were allowed in the study. * active smoking * severe known pulmonary disease * chest pathology incompatible with hbot * inner ear disease * claustrophobia * other neurological conditions * pregnancy * previous hbot within six months prior to inclusion * the inability to sign informed consent.
profile of brazilian climacteric women: the brazilian menopause study

Conditions: Menopause

Summary: cross-sectional study with 1,500 women between 45 and 65 years old. women participate by answering questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause.

this is a cross-sectional study with 1,500 women between 45 and 65 years old. the subjects participate by answering online questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause. the distribution of subjects respect the distribution of brazilian population according to country regions and according to socioeconomic class, and taking into account the information of last official brazilian demographic census.

Eligibility criteria:
inclusion criteria: * women between 45 and 65 years of age * women able to participate in a questionnaire on a digital platform and who have a device allowing this access exclusion criteria: * pregnant or lactating women

Keywords: menopause hormone replacement therapy epidemiology knowledge
effect of exercise and surgical weight loss on polyneuropathy

Conditions: Polyneuropathies; Obesity; Bariatric Surgery Candidate

Summary: the purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.

the length of this study, including screening is approximately 24 months. patients at bariatric surgery clinics will be recruited for this study. both patients that decide to undergo bariatric surgery, and those that do not undergo surgery will be enrolled. patients will be randomized to either a high intensity interval training (hiit) or standard exercise regimen after eligibility is confirmed and the baseline visit is complete. all patients will complete follow-up appointments at 3 month, 12 months and 24 months. patients that are randomized to the hiit program will compete 2 supervised and 1 unsupervised training sessions a week for 24 months.

Eligibility criteria:
inclusion criteria: * attending a bariatric surgery clinic * bmi \> 35 with one comorbid condition present or bmi \> 40 without comorbid conditions present * willing and capable to sign the institutional review board (irb) approved consent form and cooperate with the medical procedures for the study duration * willing to accept random treatment assignment to hiit or routine exercise counseling exclusion criteria: * history of distal symmetric polyneuropathy (dsp) from causes other than diabetes and/or the metabolic syndrome as determined through medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations; * use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy * contraindication to hiit participation including a failed exercise stress test * participation in an experimental medication trial within 3 months of starting the study * undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer * medical or psychiatric reason for not being a surgical candidate * requiring a walking assist device; * currently smoking

Keywords: metabolic syndrome exercise
real world evidence study of statin use in brazil

Conditions: Cardiovascular Diseases; Myocardial Infarction; Stroke; Hypertension; Diabetes Mellitus; Dyslipidemias

Summary: a cross-sectional real-world data study designed to assess the use of statins in individuals assisted within the primary care system in brazil.

considering the high cardiovascular risk associated to high cholesterol levels, assessing the use of statins in secondary prevention as well as primary prevention individuals in real world settings is key to enable public health policy improvements. the aim of the present study is to assess statins use in primary and secondary prevention individuals assisted by community care workers in the primary care system in brazil, using a free real world data collection tool (ephealth database). evaluating factors associated with statins use as well as high dose statins use are also objectives of the study.

Eligibility criteria:
inclusion criteria: * all individuals aged 18 years or older registered on the ephealth database exclusion criteria: * none

Keywords: cardiovascular diseases primary prevention secondary prevention statins