Kornimate/medical-research-clean huggingface dataset:
open label safety study in acute treatment of migraine

Conditions: Migraine, With or Without Aura

Summary: the purpose of this study is to evaluate safety and tolerability of bhv-3000 (rimegepant).


Eligibility criteria:
key inclusion criteria: * subjects with 2-8 moderate to severe migraines/month * age of onset of migraines prior to 50 years of age * migraine attacks, on average, lasting 4-72 hours if untreated * ability to distinguish migraine attacks from tension/cluster headaches * patients with contraindications for use of triptans may be included provided they meet all other study entry criteria key exclusion criteria: * history of basilar migraine or hemiplegic migraine * history of hiv disease * history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. * uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening * history of gastric or small intestinal surgery or has a disease that causes malabsorption * bmi ≥ 30 * hba1c ≥ 6.5%
mycobiome evaluation in children with autism & gi symptoms

Conditions: Autism; Gastrointenstinal Symptoms

Summary: this study's primary aim is to explore the potential differences in the gut mycobiome of children with autism spectrum disorder compared to otherwise healthy children. the secondary objective of this study is to evaluate whether the presence of specific species of fungi (e.g. candida tropicalis, c. albicans, or saccharomyces cerevisiae), in stool: 1) correlates with increased gastrointestinal symptoms; 2) correlates with evidence of increased behavioral problems (as assessed by the aberrant behavior checklist or social responsiveness scale-2); or 3) plays the same role as a constituent of commensal gut microflora as in normal controls. the scale indicates severity of social deficits in the autism spectrum as mild, moderate or severe. additionally, the study aims to compare the fecal and oral fungi in these children because many fecal mycobiota are felt to originate in the oropharynx.


Eligibility criteria:
inclusion criteria: * for autistic children with gi symptoms: confirmed diagnosis of autism spectrum disorder (asd) and its severity (dsm-5: 299.00) by autism diagnostic interview (adi-r), social communication questionnaire (scq), and autism diagnostic observation schedule-2 (ados-2); substantial gastrointestinal symptoms (as indicated by score of greater than 7 on the gastrointestinal symptoms severity index) * for autistic children without gi symptoms: confirmed diagnosis of autism spectrum disorder (asd) and its severity (dsm-5: 299.00) by autism diagnostic interview (adi-r), social communication questionnaire (scq), and autism diagnostic observation schedule-2 (ados-2) * for controls: healthy children exclusion criteria: * severe sensory impairment * brain injury * major psychiatric illness (e.g., psychotic disorders that might interfere with assessment). (however, children with common psychological problems such as depression and attention deficit hyperactivity disorder will not be excluded, given that doing so would result in a sample of children with asd that would be unrepresentative of the pediatric asd population as a whole.)- children who appear genetically syndromic (based on exam in the pediatric gi clinic) * taking immunosuppressive medications * abnormal screening labs * gi diseases * allergy to antibiotics * fever or a pre-existing adverse event monitored in the study * known history of hepatitis b/c or hiv * known pregnancy * use of probiotics in the last 60 d * use of oral antibiotics/anti-fungal during the previous 2 weeks * indwelling catheters/prosthetic devices

Keywords: autism abdominal pain
the effect of vitamin d and exercise on balance in postmenopausal women

Conditions: Vitamin D Deficiency

Summary: in recent years, skeletal and nonskeletal effects of vitamin d has been studied. one of the effects of it was balance and fall prevention. however, these studies were performed on older patients who had not vitamin d deficiency. this study aimed to evaluate the effect of vitamin d replacement therapy and exercise on balance in 50-70 years-old postmenopausal women.


Eligibility criteria:
inclusion criteria: * 50-70 years-old postmenopausal women * vitamin d level\ 30 ng/ml * independant in daily life * able to do exercise * able to read and write in turkish exclusion criteria: * diabetes mellitus, * polyneuropathy, * spinal stenosis, * history of fracture or lower extremity operation, * rheumatologic diseases, * history of chemotherapy * cognitive impairment

Keywords: balance vitamin d exercise fall risk
clinical trial of the seaweed supplement fucoidan in survivors of cancer

Conditions: Fatigue; Inflammation

Summary: to determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.


Eligibility criteria:
inclusion criteria: * survivors of cancer * age 18 or older * speak and understand english * have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment. * have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "in the last week, how bad was your worst fatigue on a scale from 0-10?" * be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits. * completed informed consent exclusion criteria: * current warfarin or other anti-coagulation medication use. * current use of supplements that contain fucoidan * any allergy to fucoidan * be diagnosed with a major psychiatric illness requiring hospitalization within the last year. * be diagnosed with dementia. * be pregnant or nursing

Keywords: cancer-related fatigue
valproate sustained release minitablets (orfiril(r) long) once daily in the evening

Conditions: Epilepsy

Summary: valproate is the first line therapy in primary generalized seizures. the applied drug contains sodium valproate in sustained release minitablets. as a multiple unit dosage form these can be easily swallowed and taken independent from meals. a simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. the data of this non interventional trial were directly extracted from the physician's electronic patient database. the observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.


Eligibility criteria:
inclusion criteria: * age of 12 years and above * epilepsy patients * indication to initiation / conversion to valproate sustained release minitablets once daily exclusion criteria: * contraindication to valproate use * no indication for conversion to valproate sustained release minitablets once daily

Keywords: valproate epilepsy compliance sustained released minitablet orfiril long
cognitively-based compassion training and mindfulness attention training program

Conditions: Behavioral Resilience; Biological Resilience

Summary: this project will explore the effect of cognitively-based compassion training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.

this project will explore the effect of cognitively-based compassion training (cbct) or mindfulness training (mt) on different aspects of behavior and stress-related biology in elementary school-age children. the program will consist of 12 weeks of cbct or mt, and various social behavioral assessments will be conducted. participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers c-reactive protein will be measured.

Eligibility criteria:
inclusion criteria: * age 7-12 * enrollment at the paideia school. exclusion criteria: * poor physical health * enrollment at a school other than the paideia school.

Keywords: meditation, inflammation, children, attention
biofeedback training on shoulder muscles strength post mastectomy

Conditions: Breast Cancer Female

Summary: purpose:the purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy. background: * the most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (ul), reduced range of motion (rom) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes * one of the most common complications after breast cancer surgery is a functional limitation of the upper body. up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced rom, after surgery * shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags. * biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many americans are turning to biofeedback and other less traditional therapies for their (dana et al., 2010). hypotheses: null hypothesis research question: does biofeedback give effect on shoulder muscles strength post mastectomy?

27 patient per group to g power 90% a inclusion criteria: the subject selection will be according to the following criteria: * female patients with age range between 40-60 will participate in the study. * all patients with their informed consent. * all patients with unilateral mastectomy * all patients have shoulder muscle weakness within 2 to 4 months post mastectomy * all patients with chemo or radio therapy 1.2.b exclusion criteria: the potential participants will be excluded if they meet one of the following criteria: * metastasis * psychological disorder * lymphedema * neurological or musculoskeletal disorders

Eligibility criteria:
inclusion criteria: * the subject selection will be according to the following criteria: * female patients with age range between 40-60 will participate in the study. * all patients with their informed consent. * all patients with unilateral mastectomy * all patients have shoulder muscle weakness within 2 to 4 months post mastectomy * all patients with chemo or radio therapy exclusion criteria: * the potential participants will be excluded if they meet one of the following criteria: * metastasis * psychological disorder * lymphedema * neurological or musculoskeletal disorders
effects on quality of life with zinc supplementation in patients with gastrointestinal cancer

Conditions: Gastric Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Unresectable Esophageal Carcinoma; Unresectable Pancreatic Carcinoma

Summary: this randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. zinc may help to improve patient's quality of life by preventing zinc deficiency.

primary objective: i. assess the effects on quality of life (qol) when supplementing zinc in upper gastrointestinal (gi) cancer patients while they are receiving chemotherapy. secondary objectives: i. correlate hypoalbuminemia with serum zinc deficiency. ii. correlate zinc deficiency with neutropenia. outline: patients are randomized into 1 of 2 groups. group i: patients receive zinc orally (po) thrice daily (tid) for months 1 and 2 only of the first 4 months on therapy. group ii: patients receive zinc orally (po) tid for months 3 and 4 only of the first 4 months on therapy.

Eligibility criteria:
inclusion criteria: * patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer * patients plan to receive chemotherapy at an emory cancer center * no prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer * patients must sign informed consent exclusion criteria: * zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test
a comparison of breast tomosynthesis mammography and conventional breast imaging in the characterization of breast masses

Conditions: Fibrocystic Disease of Breast; Breast Cancer

Summary: the purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. it is thought that non-calcified breast masses will be better visualized with the new 3d technology.


Eligibility criteria:
inclusion criteria: * female * any race or ethnicity * at least 35 years old * prior screening or full diagnostic mammogram at barnes jewish breast health center exclusion criteria: * unable or unwilling to undergo informed consent * subjects who have breast implants * subjects who are unable or unwilling to tolerate compression * subjects who are pregnant or who think they may be pregnant * subjects who are currently lactating * men * women less than 35 years old * women greater than 80 years old * subjects whose breasts are larger than the tomosynthesis detector

Keywords: breast cancer mammography benign masses breast lump breast biopsy breast mass
serum biomarkers associated with postpartum t2dm in women with gdm

Conditions: Gestational Diabetes

Summary: gestational diabetes mellitus (gdm) is commonly linked to the development of type 2 diabetes mellitus (t2dm). there is a need to characterize metabolic changes associated with gdm in order to find novel biomarkers for t2dm.

gdm, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. women with a history of gdm have an approximately 7-fold higher risk for developing t2dm in the future than women without gdm. however, data on the factors associated with the development of t2dm in women with gdm are not widely available.

Eligibility criteria:
inclusion criteria: * women who were dignosed gdm. * women with singleton pregnancy. * give birth in the first affiliated hospital in sun yat-sen university. exclusion criteria: * women who were diagnosed pgdm. * younger than 18 years old. * older than 45 years old. * multiple pregnancy. * diagnosed dm before. * complicationg other diseases, like hypertension, thyroid diseases, etc. * taking any drug affect glucose and lipid metabolism.

Keywords: gdm t2dm ngt lipids
an effectiveness and safety study for levofloxacin in chronic prostatitis

Conditions: Prostatitis

Summary: the purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

the optimal duration of treatment for chronic prostatitis remains unclear. historically, therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication. levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks. this multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance) study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis. safety analyses will involve the examination of the incidence, severity, and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests. patients will receive one of the following three dosing options: levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks, or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks, or levofloxacin 500 mg orally once-a-day for 4 weeks.

Eligibility criteria:
inclusion criteria: * males 40 years of age or older * a clinical diagnosis of chronic prostatitis as evidenced by the following two criteria: 1. clinical signs and symptoms of prostatitis including a soft, tender prostate without noticeable nodularity with one or more of the following signs or symptoms: painful or difficult urination, suprapubic discomfort, painful ejaculation, low back pain, perineal discomfort, urinary frequency, urinary urgency or hesitancy, decreased urinary stream, urinary retention, pain on digital rectal examination, perineal tenderness or pain, fever, chills. 2. a history of chronic prostatitis as defined as: symptomatic prostatitis - a clinical diagnosis of prostatitis having been made for at least one previous episode that lasted four weeks, or two or more episodes during the previous twelve months. exclusion criteria: * any condition which may interfere with the evaluation of study drug including transurethral prostatectomy within six months of enrollment, the presence of a permanent transurethral catheter or a history of cystostomy or nephrostomy * taking hormone therapy * known prostatic carcinoma * allergy to levofloxacin, ofloxacin, ciprofloxacin, or other members of the quinolone class of antibacterials.

Keywords: chronic prostatitis prostatitis levofloxacin levaquin
physical activity and screen-time regulations in childcare centers - aim 1

Conditions: Childhood Obesity

Summary: the goal of this project is to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations.

pause and play will take a prospective observational epidemiological approach before and after enactment of new regulations. 10 childcare centers licensed in east baton rouge parish will be randomly selected and standardized behavioral observation scales will be used to objectively quantify the physical activity and screen-time environment of the centers and the children's behaviors both in and outside the center. these assessments will be collected twice during the 2-year grant period to capture potential changes after the policies are implemented.

Eligibility criteria:
inclusion criteria: * licensed by doe as a class a or class b childcare center * located in east baton rouge parish * current childcare enrollment of at least 18 children between the ages of 3-4 years exclusion criteria: * childcare center and/or childcare center director unwilling to participate

Keywords: childcare center regulations physical activity sedentary behavior screen-time behavior
nutritional status in retroperitoneal sarcoma.

Conditions: Retroperitoneal Sarcoma; Malnutrition

Summary: prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma

aim of our study was to investigate the feasibility of a prehabilitation policy to optimize protein energetic reserves in a group of patients affected by primary localized rps, candidate to a multiple organ resection surgery, as well as the feasibility of a standardized nutritional postoperative caloric target and its adequacy.

Eligibility criteria:
inclusion criteria: - every patient with retroperitoneal sarcoma scheduled for surgery exclusion criteria: * chronic renal failure * diabetes mellitus * emergency surgery * physical status classification system asa\>3 * any contraindication to arterial catheter in femoral artery for picco hemodynamic monitoring
optimization of treatment in patients with severe peripheral ischemia (fontaine stage iib)

Conditions: Peripheral Arterial Disease

Summary: evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients with fontaine's stage iib severe chronic ischemia, both in patients eligible for surgery both in patients for which it is only possible medical therapy

the management of patients with peripheral arterial disease (pad) stage iib and pain-free walking distance (pfwd) less than 100 meters is a major clinical problem, in view of the significant cooling of the quality of life and evolution often severe that characterizes the clinical course of these patients. revascularization surgery is the treatment of choice, but about half of patients with severe pad iib is not eligible for surgery or endovascular treatment. the usefulness of use of vasodilators or hemorheological is controversial, and medical treatment of these patients is therefore heterogeneous understanding the various pharmacologic options (for the correction of risk factors, prevention of cardiovascular events, improvement of claudication), and rehabilitative programs. iloprost, a synthetic analogue of prostacyclin, is effective in the treatment of patients with chronic critical ischemia, and its pharmacological profile (effective vasodilator, anti-platelet, and leukocyte activation) is particularly suitable to modulate multiple components pathogenesis of peripheral arterial disease. specifically, in the treatment of patients with pad iib severe, the current state is available only a retrospective study that compared the use of iloprost with that of vasodilators. aim of the study fadoi-2bpilot is to evaluate prospectively and for an observation period of 13 months, if you can get a benefit on the pain-free walking distance and on clinical outcome from "anticipated" and additional use of iloprost, in patients with severe iib stage pad treated according to current "best medical practice".

Eligibility criteria:
inclusion criteria: age \> 18 years; pain-free walking distance (pfwd) \<100 meters on two occasions 10 days apart, with \<25% difference between each other; ankle blood pressure (bp) \<70 mmhg; big toe bp \< 30 mmhg (in case of diabetic patient). exclusion criteria: pain at rest, trophic ulcers or gangrene (critical limb ischemia), if they were unable to cooperate, or one of the following conditions (contraindications or precautions for use of iloprost) was present: myocardial infarction or stroke in the previous 6 months; congestive heart failure nyha class \>ii; unstable angina; uncontrolled severe arterial hypertension (systolic bp \>180 mmhg or diastolic bp \>110 mmhg) or hypotension (systolic bp \ 500,000/mm3; renal failure requiring dialysis; liver cirrhosis; pregnancy or breast feeding; history of allergy, hypersensitivity or intolerance to iloprost or other prostanoids.

Keywords: pad; iloprost; walking distance; cardiovascular events