Kornimate/medical-research-clean huggingface dataset:
risk factors for type 2 diabetes mellitus with cognitive impairment: a cohort study

Conditions: Diabetes Mellitus, Type 2; Cognitive Dysfunction; Gut Microbiota

Summary: the aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (t2dm) with mild cognitive impairment (mci) and its pathogenesis associated with gut microbiota. a prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of linyi city people's hospital, shandong province. a follow-up survey was conducted identifying whether the participant had t2dm as an exposure factor group. socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of t2dm with mci.

the aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (t2dm) with mild cognitive impairment (mci) and its pathogenesis associated with gut microbiota. a prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of linyi city people's hospital, shandong province. a follow-up survey was conducted identifying whether the participant had t2dm as an exposure factor group. socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of t2dm with mci. therefore, it is important to explore the factors affecting t2dm with mci and screen for intervening factors, further elucidate its pathogenesis, and search for specific biological markers of early cognitive impairment in t2dm. this is socially and economically important for screening individuals susceptible to t2dm with mci so that measures can be taken for early intervention and early treatment to improve the quality of life of patients while reducing medical costs.

Eligibility criteria:
inclusion criteria: * ≥ 45 years old; * no impairments in vision, hearing, language, etc., and can cooperate to complete the questionnaire; * agree to follow-up. exclusion criteria: * have major systemic diseases, such as malignant tumors; * have serious mental illnesses.
memory and insulin in early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: to determine which parts of the brain are involved in insulin-related memory improvement in early alzheimer's disease and cognitively normal older adults.

functional mri study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early alzheimer's disease and cognitively normal older adults. the role of the apoe-e4 allele in modulating brain insulin responses is also addressed.

Eligibility criteria:
inclusion criteria: * patients with early alzheimer's disease exclusion criteria: * patients with late alzheimer's disease
melatonin versus hydroxizin for pre operative anxiety in elderly patients with hip fracture

Conditions: Preoperative Anxiety

Summary: prospective randomized trial including adukt patients scheduled for hip fracture surgery, randomization into 2 groups: group a: hydroxizin peroperatively group b: melatonin pre operatively

prospective randomized trial including adukt patients scheduled for hip fracture surgery, randomization into 2 groups: group a: hydroxizin peroperatively group b: melatonin pre operatively non inclusion criteria: patients with severe cognitive impairement primary outcome pre operative anxiety assessed with amsterdam preoperative anxiety and information scale

Eligibility criteria:
inclusion criteria: * all adult patients scheduled for hip fracture surgery exclusion criteria: * patients with contraindications for hydroxizine or melatonin patients with severe cognitive impairement

Keywords: melatonin hydroxizin hip fracture
research study to investigate how a study medicine (nnc9204- 1177) affects blood levels of other medicines in healthy people

Conditions: Healthy Volunteers; Overweight; Obesity

Summary: the study looks at how the study medicine (nnc9204-1177) affects other medicines in the body. participants will get the study medicine and 5 other medicines which have all been approved by the authorities. participants will get 1 injection of the study medicine each week for 11 weeks. the study medicine is injected under the skin in the stomach area. all injections will be given by study staff. participants will get 5 medicines as tablets, capsules or syrup to be taken with water at the beginning of the study and after 10 weeks of treatment with the study medicine. the study will last for about 4 months. participants will have 14 visits to the clinic with the study staff and study doctor. participants will have blood draws and 2 different kinds of electrocardiograms taken during the study. they will be asked about your mental health. people who use any medication, including herbal products, cannot take part in the study. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period or if they use birth control pills or other hormonal birth control products.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-60 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 23.0 and 29.9 kg/m\^2 (both inclusive) at screening. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (intra-uterine device (iud), vasectomised partner or sexual abstinence) * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. * use of prescription medicinal products or non-prescription drugs, except for iuds, within 14 days prior to the day of screening. * use of any herbal medicine known to interfere with the metabolic cyp pathways, such as hypericum (st. john's wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days prior to the day of screening.
identifying genomic mutations of multiple primary lung cancers by circulating tumor dna

Conditions: Carcinoma; Non-small-cell Lung Cancer; Thoracic Neoplasms

Summary: targeted next generation sequencing (ngs) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. this study is to evaluate the feasibility and application value by using ngs into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor dna (ctdna) from surgical patients

tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. dna and rna were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (ffpe) tissue. a series of cancer-related genomic alterations including single nucleotide variations (snvs), short insertions and deletions (indels), copy number variations (cnvs) and gene rearrangements were identified by a comprehensive ngs panal . high frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddpcr).

Eligibility criteria:
inclusion criteria: * patients must have given written informed consent * histopathologically confirmed nsclc * considered multiple or multifocal primary lung cancer by clinical criteria exclusion criteria: * malignant tumor history within the past 5 years * patients who received any treatment prior to resection * insufficient tumor tissue or blood sample

Keywords: circulating tumor dna heterogeneous multiple primary lung cancer
chronobiology, sleep related risk factors and light therapy in perinatal depression: the life-on project

Conditions: Depression; Depression, Postpartum; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Pregnancy Complications; Puerperal Disorders

Summary: in a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. the primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (pnd) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (life-on study). secondary aims are to explore the relationship between specific genetic polymorphisms and pnd (substudy life-on1), to investigate the effectiveness of blt in treating pnd (substudy life-on2) and to test whether a short term trial of blt during pregnancy can prevent pnd (substudy life-on3). the characterization of specific predictive and risk factors for pnd may substantially contribute to improve preventive medical and social strategies for the affected women. the study results are expected to promote a better understanding of the relationship between sleep disorders and the development of pnd and to confirm, in a large sample of women, the safety and efficacy of blt both in prevention and treatment of pnd.


Eligibility criteria:
inclusion criteria: * medically healthy * normal ocular function * gestational age between 10 to 15 weeks at time of screening * written informed consent exclusion criteria: * diagnosis of bipolar i or ii disorder (dsm-5) * recent history (less than 6 months) or current major depression or an edinburgh postnatal depression scale (epds) score \> 12 at time of inclusion * any psychotic episode, substance abuse, recent history of suicide attempt (less than 12 months) * use of antidepressants or other pharmacologic treatments for depression in the last 6 months * fetal malformations and intrauterine fetal death
duration of doxycycline treatment in em patients

Conditions: Erythema Chronicum Migrans

Summary: the purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.


Eligibility criteria:
inclusion criteria: * solitary erythema migrans exclusion criteria: * pregnancy or lactation * immunocompromised * serious adverse event to doxycycline * taking antibiotic with antiborrelial activity within 10 days * multiple erythema migrans or extracutaneous manifestations of lyme borreliosis
generation of heart muscle cells from blood or skin cells of breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. the structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. doxorubicin) and anti-her2 therapy (e.g. herceptin) develop decreased heart function.


Eligibility criteria:
inclusion criteria: * female * age greater than 18 years * willing to participate in protocol procedures with signed informed consent * assessment of lvee via echocardiogram, cardiac mri, or muga subjects in the cardiotoxicity group (tox) must meet the following criteria: * history of her2 positive breast cancer (stage i-iv) * prior/current treatment with anthracycline based chemotherapy followed by anti-her2 directed therapy or anti-her2 directed therapy alone * assessment of lvef at baseline prior to initiation of anthracycline or anti-her2 therapy and during anti-her2 therapy via echocardiogram, cardiac mri, or muga * prior confirmed diagnosis of cardiotoxicity associated with anti-her2 based therapy, defined as a decrease in lvef \> 10% from baseline to \< 53% with symptoms of heart failure (nyha class ii-iv). subjects in the no cardiotoxicity group (no-tox) must meet the following criteria: * history of her2 positive breast cancer (stage i-iv) * completion of planned anthracycline and anti-her2 therapy, or anti-her2 therapy alone * no symptoms of heart failure (nyha class ii-iv) during and at the end of anthracycline and anti-her2 therapy * assessment of lvef at baseline prior to innitiation of anthracycline or anti-her2 therapy and during anti-her2 therapy via echocardiogram, cardiac mri, or muga * normal lvef \>53% at each assessment during and at the end of trastuzumab therapy. * maximum absolute decrease in lvef \<5% from baseline during and at the end of trastuzumab therapy. * lvef assessment performed at baseline and at least two time points during trastuzumab therapy. exclusion criteria: * unwilling or unable to give skin biopsies * contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator. * known pre-existing cv disease prior to initiation of breast cancer therapy as determined by the investigator, including * obstructive coronary artery disease (stenosis \>70%) * arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\>30 seconds), ventricular fibrillation, or cardiac arrest * cardiomyopathy (ef \<53%) * heart failure (nyha class ii-iv) * valvular heart disease with equal to or greater than moderate stenosis or regurgitation

Keywords: cardiotoxicity 16-025
clofazamine for the treatment of mycobacterium avium intracellulare(mai)

Conditions: Infection, Mycobacterium Avium-Intracellulare

Summary: this protocol is an single patient ind to provide clofazamine to treat one patient who has mai and is resistant to or can not tolerate standard of care. the drug is not otherwise available.


Eligibility criteria:
inclusion criteria: * treatment of one patient with mai exclusion criteria: * no other patients will be treated

Keywords: mycobacterium avium-intracellulare
field studies on the feasibility of interrupting the transmission of soil-transmitted helminths (sth)

Conditions: Helminthiasis; Filariasis

Summary: over 1.5 billion people are infected with soil-transmitted helminths (sth). global sth guidelines recommend mda (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. however mathematical models suggests that current mda strategies are not sufficient for interrupting disease transmission in most areas. meanwhile many lymphatic filariasis (lf) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-mda surveillance. this project will conduct a series of community-based cluster randomized trials in india, malawi, and benin to determine if maintaining three years of mda with albendazole to entire communities following the cessation of lf programs can interrupt sth transmission in focal geographic areas. additionally, this study aims to compare the efficacy of community-wide mda versus targeted mda of children in interrupting the transmission of sth. nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide mda for sth. these data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.


Eligibility criteria:
treatment inclusion criteria: * ages 12 months and older treatment exclusion criteria: * children under 12 months of age * pregnant women in their first trimester * history of adverse reaction to benzimidazoles outcome sampling inclusion criteria: * resident of study clusters * ages 12 months and older * willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent * provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines) outcome sampling exclusion criteria: * less than 12 months of age * individuals who do not typically reside in the study cluster * nonconsenting or assenting individuals, as applicable

Keywords: transmission interruption intestinal nematodes soil-transmitted helminths mass drug administration benin india malawi
ngs strategy effectiveness in molecular diagnosis

Conditions: Multiple Osteochondroma; Osteogenesis Imperfecta

Summary: the coming out of next generation sequencing (ngs) technologies, with documented advantages and reduced costs respect to sanger sequencing, has provided new appealing approaches to diagnostic testing. despite this, its use for routine diagnostic purposes requires certification in terms of reliability, as well as a cost-effectiveness evaluation. to test the feasibility of using the ion torrent personal genome machine (pgm) in clinical diagnosis, we assessed its performance to detect point mutations and big rearrangements previously identified with standard techniques. the diagnostic accuracy and the cost-effectiveness will be evaluated by health technology assessment (hta) analyses.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple osteochondroma * clinical diagnosis of osteogenesis imperfecta
effect of triticale, mung bean and adzuki bean intervention on patients with type 2 diabetes

Conditions: Type2 Diabetes Mellitus

Summary: this study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

the study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. patients will be assigned to control or intervention group (a diet including triticale and mung bean; b diet including adzuki bean). blood and urine samples will be collected at baseline and after 30 days of intervention.

Eligibility criteria:
inclusion criteria: 1. male and female patients between the ages of 30 and 65 years 2. patients has been diagnosed as type 2 diabetes mellitus 3. patients who like to be followed up for 2 months. exclusion criteria: 1. women in pregnancy or lactation. 2. individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.
study to investigate prucalopride vs. polyethylene glycol 3350 on colon activity

Conditions: Chronic Constipation

Summary: to evaluate the different effects of prucalopride and peg 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.


Eligibility criteria:
inclusion criteria: * chronic constipation * male or female ages 18-75 years * non-pregnant, non-lactating female exclusion criteria: * drug-induced constipation * subjects suffering from secondary causes of chronic constipation, such as: * endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy. * metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy * neurological disorders, e.g. parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, chaga's disease, or major depression * surgery. * subjects with insulin-dependent diabetes mellitus * rectal evacuation disorder/outlet obstruction * subjects with intestinal perforation or obstruction * severe renal impairment * subjects with a history of alcohol or drug abuse * subjects with lactose intolerance * subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
investigating and characterizing the immune response to prostate cancer

Conditions: Prostate Cancer

Summary: this study is a clinical study to investigate and characterize the immune response profile to four different prostate cancer treatments (total cryotherapy, focal cryotherapy, cyberknife sbrt, and radical prostatectomy) in patients with localized prostate cancer.

the immune system plays an important role in cancer, and there is evidence that different types of cancer treatment can elicit different responses from the body's immune system. this study is designed to look at immune markers in the blood and urine of patients undergoing four different types of prostate cancer treatment and compare the differences. patients who have elected total cryotherapy (freezing of the entire prostate), focal cryotherapy (freezing only the side of the prostate affected by cancer), cyberknife stereotactic body radiation therapy (sbrt) and radical prostatectomy (removal of the entire prostate) for the treatment of their prostate cancer will be eligible to participate in this study. the study is expected to enroll 40 patients, 10 patients per treatment group. the study includes a screening visit during which the subject will provide informed consent, and provide a blood sample and a urine sample. at 2-3 weeks following their scheduled treatment, they will again provide another blood and urine sample. at their regularly scheduled follow up at 3 months, they will again provide another blood and urine sample. these samples are collected for research purposes only, and the costs will be covered by the study grant account, without any additional cost to the patient. the investigators have determined that this study presents no more than minimal risk to patients due to the minimal risks involved with a blood draw and urine specimen collection.

Eligibility criteria:
inclusion criteria: * patient is willing and able to freely sign informed consent to enroll in the study. * histologically proven prostate carcinoma. * undergoing total cryotherapy, focal cryotherapy, cyberknife sbrt or radical prostatectomy for prostate cancer treatment. exclusion criteria: * has previously had a radical prostatectomy for prostate cancer. * has previously received cryotherapy for prostate cancer. * previous treatment with chemotherapy within the past 6 months. * previous treatment with radiation within the past 18 months. * has evidence of metastatic disease. * has a current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study. * has a major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal or hematological disorders, recent stroke or myocardial infarction), in the opinion of the urologist, is an illness or complication which is not consistent with the protocol requirements. * is not willing to undergo the necessary follow-up for the trial period. * has known immunologic disease, human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related illness.

Keywords: cryotherapy radiation prostatectomy immune response