Kornimate/medical-research-clean huggingface dataset:
use of flaxseed(alpha linolenic acid) powder in morbidly obese patients with systemic inflammation

Conditions: Morbid Obesity; Atherosclerosis; Systemic Inflammation

Summary: preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.as omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.

population:morbidly obese non-smoking patients of the department of gastroenterology, candidates for possible bariatric treatment criteria for inclusion: males and females, 18- 65 years old, body mass index/bmi \> 40 kg/m2 (or \> 35 kg/m2 with comorbidities), non-hospitalized and receiving general oral diet, with elevated c-reactive protein/ crp (\> 5mg/l), and signing informed consent; criteria for exclusion: sirs, shock, coma or organ failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases, trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in the study; dietetic routine: daily flaxseed powder (farinha de linhaca dourada) 60 g/day (232 kcal , containing 10 g of alpha-linolenic acid/ala) or placebo (commercial manioc flour 60 g/day, 120 kcal)) during 12 weeks. an additional 60 subjects (30 patients, 30 controls) will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ala) or 30 ml/day placebo (safflower oil). methods: clinical questionnaire,nutritional assessment(weight, height, bmi) biochemical tests: hemoglobin (hb) , white blood cell count (wbc), total cholesterol (chol) and fractions (hdl, ldl, vldl), triglycerides (trig), blood glucose (glu), serum albumin (alb),insulin (ins), leptin (lep),c-reactive protein (crp), serum amyloid a (saa), complement fractions c3 and c4, coagulation profile atherosclerosis markers: arterial stiffness (aorta) and intima thickness (common carotid artery)

Eligibility criteria:
inclusion criteria: * males and females * 18- 65 years old * body mass index/bmi \> 40 kg/m2 (or \> 35 kg/m2 with comorbidities) * non-hospitalized and receiving general oral diet * with elevated c-reactive protein/ crp (\> 5mg/l); and * signing informed consent exclusion criteria: * sirs, shock, coma or organ failure, * fever or infectious foci * cancer with or without chemo/radiotherapy * inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases * trauma, surgery or hospitalization in the last 30 days * use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics; and * refusal to participate in the study

Keywords: obesity alpha linolenic acid flaxseed c-reactive protein inflammation
physical therapy for functional constipation in children

Conditions: Physical Therapy in Pediatric Functional Constipation

Summary: children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment


Eligibility criteria:
inclusion criteria: * children diagnosed as functional constipation. * aged from 4 to 18 years old * from both sex exclusion criteria: * children diagnosed as constipation caused by medicine bowel surgery, endocrine and metabolic disorders , neurological and psychiatric disorders.
intervention study of two protocols for non-surgical treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: treatment directed towards the control of periodontal infections is to about 90% non-surgical procedures. there is evidence from a large number of randomized controlled studies that the efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (fmud) is comparable to that of traditional section-wise scaling and root planing (srp). a hypothesis for the current effectiveness study is that comparable clinical effects will be obtained with the fmud approach as with conventional section-wise srp, but with significantly more favourable patient-centred and health-economic outcomes. this randomized study involves about 100 professionals (dental hygienists) and more than 850 patients at 40 dental clinics in the vastra gotaland region, sweden. the project not only evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong focus on patient-centered measures - patient-reported experience measures (prem) and patient-reported outcome measures (prom) - as well as health-economics.

all patients with chronic periodontitis (age 30 years and older) attending the selected public dental clinics in vg are eligible. the patients should have at least 8 teeth with pathological pockets (probing pocket depth ≥5 mm and bleeding on probing). only patients providing signed informed consent are included. reported data in the study by wennström et al. (j clin periodontol 2005) were used for power calculation. thus, a total sample of 834 patients will provide a power of 95% at a significance level of p\<0.05 to detect a difference of 5% in proportion of sites with "pocket closure" i.e. ppd ≤4 mm and bop negative (primary efficacy variable) between treatment groups. for a power of 80% a total sample of 506 patients is required.

Eligibility criteria:
inclusion criteria: * chronic periodontitis * at least 6 teeth with approximal probing pocket depth ≥5 mm and bleeding on probing exclusion criteria: * subgingival instrumentation within 6 months prior to screening examination * compromised medical conditions requiring prophylactic antibiotic coverage

Keywords: chronic periodontitis non-surgical therapy ultrasonic debridement scaling and root planing
a trial of using sms reminder among diabetic retinopathy patients in rural china

Conditions: Compliance; Diabetic Retinopathy; SMS

Summary: the purpose of this study is to use a randomized controlled design to determine the impact of a sms messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy in rural china.

sms message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. the investigators can use the sms system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural diabetic retinopathy patients.

Eligibility criteria:
inclusion criteria: - all the diabetes patients who would like to join our study in 5 crest cooperated rural hospitals. exclusion criteria: 1. both the patient and his/her caretakers don't have cellphone,or the one who has cellphone but don't know how to use the sms function. 2. the first re-visit appointment time is outside our study period.

Keywords: not-attended rate re-visit vision knowledge satisfaction
first in human dose escalation of m3258 as a single agent and expansion study of m3258 in combination with dexamethasone

Conditions: Multiple Myeloma

Summary: the purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of m3258 as a single agent and co-administered with dexamethasone in participants with relapsed refractory multiple myeloma (rrmm).


Eligibility criteria:
inclusion criteria: * participants having eastern co-operative oncology group (ecog) performance status less than or equals to (\<=) 1 * adequate hematological, hepatic and renal function as defined in the protocol * participant must have measurable disease of multiple myeloma (mm) and received greater than (\>) 3 prior lines of therapy for mm including a proteasome inhibitors (pi), an immunomodulatory imide drug (imid) and an anti-cd38 mab or who are refractory to at least pi agent (carfilzomib or bortezomib) and imid according to the international myeloma working group (imwg) criteria * participant must have documented evidence progressive disease as defined by the imwg criteria either on or after their last regimen * other protocol defined inclusion criteria could apply exclusion criteria: * any condition, including any uncontrolled disease state that in the investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. * an active second malignancy or evidence of disease of cancer (other than mm) before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years). * cerebrovascular accident/stroke (\< 6 months prior enrollment) or neurologic instability per clinical evaluation due to tumor involvement of the central nervous system * diagnosis of fever within 1 week prior to study intervention administration * part b: participants planning to undergo a stem cell transplant should not be enrolled to reduce disease burden prior to transplant. * other protocol defined exclusion criteria could apply

Keywords: m3258 dexamethasone pharmacokinetics relapsed refractory multiple myeloma
comparison of stentoptimizer with intravenous ultrasound and 2d quantitative coronary angiography

Conditions: Coronary Artery Disease

Summary: the primary objective of this study is to determine the diagnostic efficiency and accuracy of using the stentoptimizer. the ability of stentoptimizer to influence post deployment treatment strategy will be assessed and compared to the ivus system. in addition, the correlation of diameter measurements between the stentoptimizer, ivus and 2d qca will be assessed. the stentoptimizer software, ivus and 2d qca were all part of the clinical procedure outside the study. the analysis of post deployment treatment decisions and diameter measurements using those modalities retrospectively make this an observational study.

stent under-expansion is defined as the minimum stent area by itself or compared with a predefined reference. it plays a role in the pathogenesis of adverse events following stent deployment. stent under-expansion has been a consistent finding in ivus reports of acute or subacute bms or des thrombosis. post intervention imaging can determine whether there is adequate stent expansion. currently the only available tool for evaluation of properness of stent deployment is intravascular ultrasound (ivus). ivus procedure is invasive, labor intensified, associated with radiation and contrast media use, and is not free of complications. in many medical centers, ivus is not used routinely because of lack of knowledge and expertise in reading it, and it's relatively high price. the stentoptimizer is an angiography based software tool aimed to enhance visualization of deployed stents and to provide the physician with quantitative data regarding stent dimensions. the stentoptimizer is part of an image acquisition and processing software system (ic-pro), designed as an add-on to conventional x-ray angiography systems. an enhanced stent image is produced using the radiopaque markers of the delivery balloon from several frames (minimum 20). the result is a still image of the stent with enhanced edges and the region of interest around it

Eligibility criteria:
inclusion criteria: 1. percutaneous coronary intervention indicated clinically. 2. ivus used as part of the standard procedure. 3. subject must be \>=40 yrs. 4. subject must provide written informed consent. exclusion criteria: 1. low image quality as determined by the investigator. 2. subject is pregnant or nursing. 3. acute st segment elevation myocardial infarction (stemi) that has not been stabilized.

Keywords: stent under-expansion stentop stentoptimizer ivus ic-pro image enhancement
clinical evaluation of neoplex4 assay and neoplex system

Conditions: Adrenal Hyperplasia, Congenital; Congenital Hypothyroidism; Cystic Fibrosis

Summary: the purpose of this study is to assess the agreement of clinical performance between the proposed neoplex 4 assay and neoplex system and the comparator devices in clinical use in newborn screening programs for detection of t4, tsh, 17-ohp and irt.

the proposed (investigational) neoplex4 assay measures levels of thyroxine (t4), thyrotropin (htsh), 17-alpha-oh-progesterone (17-ohp) and immunoreactive trypsinogen (irt) from dried blood specimens (dbs) collected from neonates to screen for congenital hypothyroidism (ch), congenital adrenal hyperplasia (cah) and cystic fibrosis (cf). the clinical evaluation of the xmap® neoplex4™ assay (neoplex4) for detection of t4, tsh, 17-ohp and irt using the neoplex system is a multi-center method concordance study on a combination of prospectively collected neonatal dried blood spots and pre-selected archived frozen dried blood spots that have been demonstrated to be positive for 17-ohp (cah), irt (cf), and t4 or tsh (ch). the study will be conducted at selected sites that routinely perform newborn screening testing in the united states.

Eligibility criteria:
inclusion criteria: * the dried blood spot specimen was collected on an fda-cleared collection paper that has not yet passed its expiration dating. * prospective specimens used in this study should only be those collected for the first time from a subject, or initial collection specimens. exclusion criteria: * collected within 24 hours of birth. * specimens stored at ambient temperature for greater than 14 days prior to testing. * the specimen dbs appears diluted. * the specimen dbs shows evidence of clotting, caking, layering or serum rings. * the dbs punched disks were punched too close to the edge of the blood spot or show printed markings. * the specimen or collection card was contaminated with fecal material. * non-eluting blood spot due to deterioration of sample caused by exposure to heat and humidity.
the effect of time on generalization of exposure-based benefit

Conditions: One Week Follow-up Assessment; Six Weeks Follow-up Assessment; Three Months Follow-up Assessment

Summary: participants will receive a pre-assessment and an exposure with a control spider. this control spider will be presented again at post-training assessments. participants will then be assigned to one of the follow-up assessments: one week, six weeks or three months. the control spider (spider a) and a novel spider (spider b) will be used again at follow-up bats to test for generalization of exposure effects.

several findings from basic research on extinction learning undermine the role of time effects in the contextualization and retrieval of extinguished memories (archbold et al., 2013; quirk, 2002; wiltgen \& silva, 2007). the latter bears important implications for the evaluation of short- and long-term effects of exposure-based fear reduction and generalization. to date, no study exists examining the role of time on the fear responding to treated stimuli and/or untreated stimuli after successful exposure. it will be investigated whether the differential responding to treated and untreated stimuli after exposure is dependent on the passage of time. spider fearful participants will be subjected to a standardized one-session treatment with spiders serving as treatment stimuli. fear reduction towards treatment stimuli will be assessed at post-treatment. furthermore, generalization of exposure therapy towards untreated stimuli (i.e., a novel spider) will be assessed. the extent of generalization of exposure-based fear reduction to untreated stimuli will be compared between three groups that will differ with respect to the follow-up length. here, participants undergoing exposure will be randomly assigned to one of the following follow-up measurements: one week follow-up, six weeks follow-up, and three months follow-up. the extent of exposure induced fear reduction and generalization will be assessed and compared between these groups.

Eligibility criteria:
inclusion criteria: * presence of fear of spiders (potential diagnosis of arachnophobia) exclusion criteria: * reaching level 10 or higher in the initial (pre-exposure) spider bat * any acute or chronic mental and / or somatic disease * psychological, psychiatric, neurological or pharmacological treatment * drug or alcohol abuse * pregnancy

Keywords: exposure therapy generalization of exposure effects fear of spiders anxiety disorders extinction specific phobia
motor-cognitive interventions are effective in improving cognitive function in older adults with mild cognitive impairment--a chinese sample

Conditions: MCI

Summary: mild cognitive impairment (mci) is a syndrome that occurs in the preclinical stage of alzheimer, and early intervention can be effective in preventing alzheimer, but further research is needed on intervention methods. in order to identify interventions that are more suitable for chinese characteristics and to investigate the effects of a motor-cognitive intervention on the cognitive function of older adults with mci, investigators screened 103 community-dwelling older adults with mci aged 65 years and older in qingdao, shandong, china, and divided them into an intervention group and a control group, and administered a motor-cognitive intervention to the intervention group for 12 weeks. investigators assessed the cognitive abilities of mci participants using the mini-mental state examination (mmse) and montreal cognitive assessment (moca). there were no demographic differences between the intervention and control groups. investigators found that the cognitive abilities of the intervention group were significantly improved at the end of the intervention as well as at the end of the follow-up compared to the control group. the results of the current study suggest that the motor-cognitive intervention investigators used significantly improved cognitive function in older adults with mci and was easy for older adults to master, and that it was a good intervention for cognitive function in older adults with mci in the chinese community.


Eligibility criteria:
inclusion criteria: * age ≥65 years old; * the screening results were mild cognitive impairment; * those who have the ability to walk independently or use auxiliary tools and can ·communicate with each other normally; * informed consent, willing to participate in the researcher. exclusion criteria: * people with mental disorders; * patients with serious organ diseases, such as kidney and heart failure; * people with mobility disabilities.

Keywords: motor-cognitive intervention older adults cognitive ability mild cognitive impairment
extension to study on efficacy and safety of linzagolix for the treatment of endometriosis-associated pain

Conditions: Endometriosis

Summary: the primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with abt (e2 1 mg / neta 0.5 mg), in the management of moderate to severe endometriosis-associated pain (eap) in women with surgically confirmed endometriosis.

this is a prospective, randomized, double-blind study. subjects who have completed the 6-month treatment period in 18-obe2109-002 - edelweiss 2 study (herein referred to as main study) will be invited to enter the present extension study. month 6 visit of the main study is a decision point for subjects to either end treatment and enter a post-treatment follow up (part of the main study), or to opt for a 6-month treatment extension. all subjects will receive once daily either linzagolix 75 mg alone (with abt placebo) or 200 mg combined with abt for 6 months. subjects who received placebo during the main study will be randomized to either linzagolix 75 mg alone (with abt placebo) or linzagolix 200 mg with abt. subjects who received active treatment during the main study will continue with the same treatment. double-dummy design will be used in order to maintain the blinding of the study. after end of treatment in the extension study (6-month treatment period: from month 6 to month 12), subjects will enter a post-treatment follow-up period of 6 months with no investigational medicinal product (imp) or - for subjects willing to continue treatment - a second extension study will be proposed.

Eligibility criteria:
inclusion criteria: the subject must have: * completed the 6-month treatment in the main study * agreed to continue to use only the analgesic rescue medication permitted by the protocol during the treatment and follow-up periods * agreed to continue to comply with the requirements of the study protocol for the duration of the extension study exclusion criteria: the subject will be excluded if she: * is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the follow-up period) * likely to require treatment during the study with any of the restricted medications * has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (tvus), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives * meets any of the main study discontinuation criteria

Keywords: dysmenorrhea dyspareunia dyschezia non-menstrual pelvic pain
mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes

Conditions: Gestational Diabetes; Type 2 Diabetes Mellitus; Glucose Intolerance; Healthy Lifestyle

Summary: although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (gdm) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. the low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (t2dm), we designed the melinda pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of gdm to promote a healthy lifestyle.


Eligibility criteria:
inclusion criteria: * aged 18 or older * gdm based on the 2013 who criteria * glucose intolerance (prediabetes based on the ada criteria) based on the 75g ogtt 6-16 weeks after delivery exclusion criteria: * diabetes; * current use of metformin; * normal glucose tolerance (ada criteria); * health limitations or treatments which would restrict the participation in the intervention trial. * has no smartphone