Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of sr46349b in patients with sleep disorders in fibromyalgia

Conditions: Fibromyalgia; Sleep; Chronic Pain

Summary: fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. by improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.

the purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). the study will last approximately 70 days and will include 7 office visits.

Eligibility criteria:
inclusion criteria: * each patient must fulfill the diagnosis criteria of fibromyalgia according to the american college of rheumatology * based on patient's information: * the patient must complain of unrefreshing sleep for at least 3 nights per week over the past month. * the patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks. * female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study * written, signed and dated informed consent must be obtained from each patient * willing to abstain from taking any medication or treatment prohibited as per the protocol exclusion criteria: * females who are lactating or pregnant * night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day). * consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day * past or current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
severe insulin resistance in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.

overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. the sedentary lifestyle and overly rich nutrition are predominant in western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. according to the who an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. it is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. it is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.

Eligibility criteria:
inclusion criteria: * age 25-75 years old * bmi between 25 and 42 exclusion criteria: * severe diseases

Keywords: type 2 diabetes severe insulin resistance
the immediate effects of soft tissue mobilization on posterior shoulder tightness in overhead athletes with subacromial pain syndrome

Conditions: Posterior Shoulder Tightness; Subacromial Impingement Syndrome

Summary: the aim of this study is to investigate the immediate effects of soft tissue mobilization on shoulder mobility, pain, scapular kinematics and muscle activation and muscle stiffness in symptomatic overhead athletes with posterior shoulder tightness.


Eligibility criteria:
inclusion criteria: * amateur overhead athletes aged 18-50 years. * participation in overhead sports training for more than 4 hours per week. * playing experience of more than 3 years. * shoulder range of motion deficits: internal rotation range of motion (rom) on the affected side is at least 10 degrees less than the unaffected side, and total rotational rom (internal rotation + external rotation) is at least 5 degrees less than the unaffected side, or horizontal adduction rom is at least 10 degrees less than the unaffected side. * patients with subacromial pain syndrome: diagnosis requires at least 3 out of 5 positive test results (hawkins-kennedy impingement test, neer impingement test, empty can test, painful arc test, and external rotation resistance test). exclusion criteria: * negative result on the kinetic medial rotation test. * history of shoulder fracture, dislocation, or upper limb injury requiring surgery within the past 6 months. * inability to complete the experiment due to personal factors. * shoulder pain intensity greater than 7 points on the visual analog scale (vas). * history of direct trauma to the neck or upper limb within the past month. shoulder pain and neurological symptoms originating from the cervical spine. contraindications to soft tissue mobilization, such as open wounds in the treatment area, skin cancer, localized infection, severe edema, vascular disorders, or acute muscle tears in the treatment area

Keywords: posterior shoulder tightness subacromial impingement
atopic dermatitis-like skin disease in pediatric heart transplant patients

Conditions: Dermatitis

Summary: the skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.

we want to determine whether pediatric heart transplant patients with an atopic dermatitis-like rash report a personal and/or family history of atopy (asthma, allergies and atopic dermatitis). in addition comparisons will be made between the presence of atopy between patients with and without the skin rash. comparisons will be made of systemic immunosuppressive therapies between patients with and without the atopic dermatitis-like rash. determination will be made as to whether histologic characterization of a skin biopsy specimen is consistent with ad. thorough evaluations will be made of patients in the clinic with this rash and the presence of bacterial superinfection will be ruled out.

Eligibility criteria:
inclusion criteria: * patients must have had a heart transplant. * patients must be less than 16 years of age. exclusion criteria: * patients who have not had a heart transplant. * patients who are greater than 16 years of age.

Keywords: post pediatric heart transplant
evaluation of the axonemal dynein heavy chain 5 and creatine kinase concentration in cervical fluid for early detection of the ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: patients who have doubt for ectopic pregnancy will be enrolled for our study. these patients will be determined with using irregular increased human chorionic gonadotropin (beta-hcg) results and no embryo reported ultrasonography results. plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. concentration of these proteins in samples will be evaluated. if any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.


Eligibility criteria:
inclusion criteria: * doubted ectopic pregnancy * without any finding about intrauterine pregnancy in ultrasonography results * without any vaginal bleeding * having irregular pregnancy test results * beta-hcg results should be at least upper than 100 milli-international unit (miu/ml) * having fist trimester pregnancy for intrauterine pregnancy group * without any emergency findings exclusion criteria: * doubted incomplete abortion * having vaginal bleeding * having ultrasound results which include intrauterine embryo report * having lower than 100 miu/ml beta-hcg results * without fetal heart rate in intrauterine pregnancy group * having older than fist trimester pregnancy for intrauterine pregnancy group * having emergency findings

Keywords: ectopic pregnancy axonemal dynein heavy chain 5 creatine kinase cervical fluid
lymphovenous bypass procedure before underarm lymph node surgery in preventing lymphedema in patients with inflammatory or locally advanced non-inflammatory breast cancer or melanoma

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Breast Inflammatory Carcinoma; Locally Advanced Breast Carcinoma; Melanoma

Summary: this pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. the lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. it is usually done after a diagnosis of lymphedema. in this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

primary objectives: i. to evaluate the protective benefit to performing standard of care lymphovenous bypass (lvb) surgery at the time of standard of care axillary lymph node dissection (alnd) for patients that are high risk for developing breast-cancer related lymphedema (le) of the upper extremity. secondary objectives: i. compare the medical outcomes for patients that received the lvb surgery with those receiving standard surgery in whom the intervention could not be performed. outline: patients are randomized to 1 of 2 groups. group i: patients receive indocyanine green intravenously (iv) and undergo lymphangiography, then undergo lvb at the time of alnd. group ii: patients do not receive indocyanine green, undergo lymphangiography, nor undergo lvb at the time of alnd. after completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.

Eligibility criteria:
inclusion criteria: * patients greater than or equal to 18 years of age. * patients willing to participate. * patients able to complete informed consent. * patients will be eligible for inclusion if they fall into one for two groups: * patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing alnd and are anticipated to receive radiation therapy * or: patients with a diagnosis of melanoma (including unknown primary) that will undergo alnd will also be eligible for inclusion in the study as a comparator group. exclusion criteria: * patients taking anticoagulants within 7 days prior to surgery. * patients that are known to be pregnant at the time of surgery. * patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period. * patients with body mass index (bmi) greater than 50.0.
controlled exposure of healthy nonsmokers to secondhand and thirdhand cigarette smoke

Conditions: Pollution; Exposure; Smoke Inhalation; Exposure to Pollution

Summary: this study compares the health effects of dermal and inhalational exposure to thirdhand cigarette smoke to those of inhalational exposure to secondhand cigarette smoke in healthy, adult nonsmokers. our hypothesis is that dermal exposure increases exposure to the tobacco specific carcinogen, nnk and may affect both endothelial function and epidermal integrity.

thirdhand cigarette smoke is the smoke chemicals that persist in the environment after smoking. indoors, they can be found both on surfaces and in the air. thirdhand smoke derives from secondhand smoke and contains the chemicals that stick to surfaces, are re-emitted into the air and that form by chemical reactions both on surfaces and in the air. thirdhand smoke can contain higher concentrations of the tobacco-specific nitrosamine and known carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (nnk) than secondhand smoke, because nicotine reacts to form nnk in the indoor environment. dermal exposure to thirdhand smoke includes nicotine, nnk and other tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and volatile organic compounds. inhalational exposure to thirdhand smoke includes nicotine, ultrafine particles and volatile organic compounds. previous studies have shown that inhalational exposure to secondhand cigarette smoke causes endothelial dysfunction, which is a risk factor for heart disease and heart attacks.

Eligibility criteria:
inclusion criteria: * healthy on the basis of medical history, blood pressure and test of c-reactive protein, lipids and blood sugar. * non-smoker not exposed to second-hand smoke (shs) as determined by saliva cotinine \< 10 ng/ml and tetrahydrocannabinol (thc) \< 50 ng/ml. * flow mediated dilation of 4% or greater at screening visit. exclusion criteria: * age 18 \ 50 physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma. unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications systolic blood pressure \> 150 diastolic blood pressure \> 100 blood glucose \> 110 ldl \>130 pregnancy or breastfeeding (by urine human chorionic gonadotropin (hcg) and/or history) alcohol or illicit drug dependence within the past 5 years bmi \> 35 and \< 18 current illicit drug use (by history or urine test) more than 1 pack year smoking history ever a daily marijuana smoker smoked anything within the last 3 months unable to hold allergy or other over-the-counter (otc) medicines occupational exposure to smoke, dusts and fumes concurrent participation in another clinical trial unable to communicate in english no social security number
culturally-adapted diet for puerto rican adults

Conditions: Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; High Triglycerides; High Blood Glucose; Abdominal Obesity

Summary: this pilot project will determine whether a diet culturally-adapted to puerto ricans can effectively decrease cardiometabolic risk for diabetes. this will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.

this pilot intervention will culturally-tailor a diet to the puerto rican adult population based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk factors of type 2 diabetes and obesity. based on preliminary results from studies in the island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in puerto rico with at least 2 of 5 cardiometabolic risk factors. the two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. a reinforcement phase of 2-months will follow to repeat the education and text messages. investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.

Eligibility criteria:
inclusion criteria: 1. age 25-65 y old at the time of enrollment 2. non-institutionalized 3. living in pr at the time of recruitment and for at least the previous year and not planning to move from the island within the next 6 months 4. able to answer questions without assistance 5. having a cellphone with the capacity to receive text messages 6. having at least two of the following: 1. elevated bmi 2. elevated waist circumference 3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure 4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes 5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia exclusion criteria: 1. under 25 or over 65 years of age 2. currently do not live in puerto rico or have not lived in pr for at least 1 year or plan to move within 6 months 3. institutionalized 4. not able to answer questions without assistance 5. not having at least 2 of the five listed metabolic criteria 6. self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory. 7. self-reported pregnancy 8. gastrointestinal or chronic conditions 9. food intolerance or allergies
genetic variants affecting the clinical severity of beta thalassemia

Conditions: Beta Thalassemia

Summary: β-thalassemia is one of the most common single gene disorder in southern china. the phenotypic severity of beta thalassemia widely varies from mild to severe forms. patients with the same beta thalassemia genotype show wide phenotypic variability that ranges from moderate to severe disease due to various genetic modifiers of disease severity. the aim of this study is to looking for the genetic factors which could affect the severity of beta thalassemia.

the understanding of the genotype-phenotype correlation is a very important issue to the precise diagnosis of beta thalassemia. however, the genotype-phenotype correlation of beta thalassemia is so complex that the pathogenesis of some patients remains uncertain and cannot be explained by known mechanisms. the study of the role of the genetic variants in modulating beta thalassemia phenotype could brought us considerable novel and interesting information in this area. we will collecting more than 1000 beta thalassemia patients , analyzing their clinical data and genome data, and association study will be conducted to screen the positive genetic variants which exert a significant effect on both the hbf levels and onset ages of beta thalassemia patients.

Eligibility criteria:
inclusion criteria: * diagnosed with β-thalassemia exclusion criteria: * iron deficiency anemia

Keywords: beta thalassemia hb f onset age genetic modifier
biomarkers in tissue samples from young patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

objectives: * to determine whether the pattern of global and tsg-specific promoter cpg island hypermethylation and gene silencing that we have shown characterizes mll-rearranged (mll-r) infant bilineage all is also characteristic of other subsets of mll-r leukemia. outline: previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via help arrays, gene expression arrays, and rt-qpcr. projected accrual: a total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

Eligibility criteria:
disease characteristics: * available cryopreserved cells from diagnosis * at least 2 x 10\^7 viably cryopreserved cells * one of the following biologically defined cytogenetics/molecular cohorts: * t(9;11) * t(11;19) * other 11q23 translocations * normal cytogenetics patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies
mindfulness-based stress reduction for bowel symptoms: collection of pilot survey data

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the united states. therapy for ibs is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. accumulating evidence indicates that persons with ibs have a heightened perception of stress, and chronic stress has been shown to have a significant impact on ibs symptomatology. mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. the clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. the purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (mbsr) improves symptoms and quality of life for persons with ibs. patients in the 8-week mbsr program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the mbsr course. this study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of mbsr.

aim 1: apply measures of ibs symptom severity, depression and quality of life before and after the mbsr course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. aim 2: apply a validated measure of mindfulness before and after treatment. aim 3: explore the relationship between ibs symptoms, mindfulness score, and frequency of mindfulness practice.

Eligibility criteria:
inclusion criteria: * all patient who enroll in a mbsr course exclusion criteria: * psychosis, borderline personality, active substance abuse

Keywords: irritable bowel mindfulness stress meditation