Kornimate/medical-research-clean huggingface dataset:
trial of mesalamine for the treatment of active microscopic colitis

Conditions: Microscopic Colitis; Diarrhea

Summary: subjects must be 18 years old and older, have diarrhea and microscopic colitis. pregnant or nursing females are excluded. they can't have other untreated diarrheal conditions. subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. the subjects will be monitored weekly. a pathologist will review pre and post treatment biopsies. subjects that show improvement will be followed for 4 weeks post medication.

we propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose. we will recruit 70 subjects. the subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. the subjects will be monitored weekly. a pathologist will review pre and post treatment biopsies. responders will be followed for 4 weeks post medication. subjects must be 18 years old and older, have diarrhea and microscopic colitis. subjects will be excluded if they have unsuccessful treatment or side effects to 5-asa drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. subjects may not be on anticholinergics, cholestyramine, digoxin. pregnant or nursing females are excluded. they can't have other untreated diarrheal conditions. a two-sample z-score test for proportions will be used to test whether relief rates are different between groups.

Eligibility criteria:
inclusion criteria: * subjects must be 18 years old and older. * have diarrhea and microscopic colitis. * they need to have a colon biopsy done at the mayo clinic in rochester, mn within a year of enrollment. exclusion criteria: * none.
mothers with a history of depression and their 10-14 year old daughters

Conditions: Depression; Depressive Disorder, Major

Summary: the purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. the investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.

the purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. we are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters. we use a range of methodologies to evaluate these processes, including self-report measures, information-processing performance, hpa-axis functioning and reactivity, and neural responses to emotional stimuli following exposure to stressful experiences.

Eligibility criteria:
inclusion criteria: * eligible mothers must read and speak english fluently and have a child between the ages of 9 and 15 years old. * mothers must either have no history of psychopathology or have a history of depression during their child's lifetime. exclusion criteria: * eligible mothers cannot: * currently be in treatment for drug or alcohol abuse * have significant symptomatology related to psychopathology outside of depression * have a medical history of neurological injury or impairment. * mothers who meet the requirements for inclusion in the control group must not have a history of any axis i disorder.
safety study of adenovirus hepatocyte growth factor to treat ischemic heart disease

Conditions: Ischemic Heart Disease

Summary: to explore the safety and efficiency of adenovirus-hepatocyte growth factor(ad-hgf) treatment in ischemic heart disease.

1. ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply. 2. gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. in this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.

Eligibility criteria:
inclusion criteria: * person with ischemic heart disease; * male or female of 20 to 70 years old; * no blood perfusion detected in some area of heart using single-photon emission computed tomography(spect) or magnetic resonance imaging(mri) * two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg)；or patients refuse to perform pci or cabg * lvef is ≤45%; * patients must sign approved informed consent. exclusion criteria: * acute myocardial infarction occured within one week * cabg performed within 6 months or pci performed within 3 months * patients with systemic active infection * blood alanine aminotransferase (alt)\>135mmol/l or blood crea(cr)\>200umol/l or patients with chronic obstructive pulmonary disease (copd) * patients with obvious bleeding tendency and blood disease * patients with malignant tumor or end-stage disease * patient anticipated life expectancy is less than 12 months * patient recently attended test drugs or other device research

Keywords: ischemic heart disease adenovirus hepatocyte growth factor
effect of novel antidiabetic drug combined with angiotensin receptor/neprilysin inhibitor on urinary protein

Conditions: Type 2 Diabetes; Antidiabetic Drugs

Summary: the purpose of this study is to determine whether the combination of sglt2i and arni in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

this project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * clinical diagnosis of type 2 diabetes mellitus * immediate urine albumin creatinine ratio greater than 30mg/g * signed informed consent and available for follow-up exclusion criteria: * severe renal insufficiency, i.e. egfr ≤ 30ml/min/1.75m2 * clinical diagnosis of various acute and chronic urinary tract infections * combined with various serious infectious diseases * combined with acute complications of diabetes mellitus * end-stage malignancy * pregnancy and lactation
functional outcomes comparison in patients using knee brace post acl reconstruction with autograft bone quadricep tendon

Conditions: Anterior Cruciate Ligament Injuries; Arthroscopy; Braces

Summary: this study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after acl reconstruction with bone quadriceps tendon per arthroscopy.

this study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after acl reconstruction with bone quadriceps tendon per arthroscopy. the research will be conducted at the national central general hospital dr. cipto mangunkusumo, jakarta police hospital and gatot soebroto army hospital in jakarta, indonesia.

Eligibility criteria:
inclusion criteria: * adult patients with age more than equal to 18 years * patients with acl rupture without other ligament ruptures undergoing acl reconstruction * patients undergoing acl reconstruction using quadricep tendon autograft exclusion criteria: * patients with hyperlaxity * patients with previous history of acl reconstruction * patients with recurrent rupture during the observation period

Keywords: anterior cruciate ligament injuries arthroscopy knee braces functional outcome
liver fibrosis assessment with shearwave elastography

Conditions: Liver Fibrosis

Summary: chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. shearwave™ elastography, available on the aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver. this study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

the measurements of liver stiffness made by the aixplorer® will be compared to (where available) : * blood markers * biopsy results * other stiffness measurement exams (fibroscan, arfi, elastpq...) the influence of other (confounding) factors on the reliability of swe measurements will be analyzed.

Eligibility criteria:
inclusion criteria: * patients meeting a single condition below: * chronic hepatitis b, defined by serology hbsag positive and the presence of dna / rna in the serum, or * chronic hepatitis c, defined by serology anti-hcv positive and the presence of dna / rna in the serum, or * non-alcoholic fatty-liver disease * and meeting all of the conditions below: * liver biopsy for histological evaluation of liver fibrosis * length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis) * age of majority in their country * obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites. exclusion criteria: * cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease * history of antiviral therapy for 6 months or less of current antiviral therapy * any systemic, viral hepatitis and hiv co-infection * pregnant woman * failure to obtain consent * length of all liver biopsy specimens below 15mm

Keywords: liver fibrosis shearwave elastography ultrasound
sleep and central auditory processing disorder in autism spectrum disorder

Conditions: Central Auditory Processing Disorder; Autism Spectrum Disorder; Sleep Disturbance

Summary: the proposed study aims to understand poor sleep as a possible cause to capd in children and adolescents with asd (asd+) compared to asd youth without capd (asd-), using both caregiver-report and objective clinician administered measures. additionally, the study will aim to understand the complex relationship between capd, sleep, and other associated phenotypic features of asd such as executive and psychiatric functioning.

participation will involve one assessment session approximating 4 hours including administration of neurocognitive and socioemotional measures by trained research staff. the research team then will determine which participants meet capd diagnostic criteria for both the scan-3 and rgdt tests and assign them to the asd+ group. participants not meeting these criteria will be assigned to the asd- group. following the assessment visit, all participants will then be asked to wear actigraphy monitors (comparable to overnight polysomnography) regularly for 14 days during nighttime sleep to objectively measure sleep quality.

Eligibility criteria:
inclusion criteria: * have diagnosis of autism spectrum disorder confirmed by the autism diagnostic observation schedule and the social communication questionnaire, lifetime version which will be filled by the parent * iq of 50 or higher on the abbreviated battery iq score exclusion criteria: * no confirmed diagnosis of autism spectrum disorder * history of sleep apnea * history of restless leg syndrome * history of any neurological disorders (e.g., seizures, tumors, etc.) * significant substance use in the past six months * inpatient hospitalization in the past three months-period
endostar combined with concurrent radiochemotherapy for treatment of unresectable stage iii nsclc

Conditions: Unresectable Stage III NSCLC

Summary: the chemoradiotherapy (ccrt) is still a standard treatment for the unresectabl stage iii nsclc.however, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. the result of published helper study had showed that endostar, a kind of angiogenesis agent, in combination with ccrt could improve the efficacy and safety. in order to verify the rusults, the investigators design the current study.

the current study is a observation study in the real world setting. the 500 patients in compliance with enrollment criteria will be as the objects of observation. the procedure of study include the period of screening, treating and follow-up. the duration of study is about two and half year. the data entrying will be done by crc, using the edc system. cra will audit the quality of data regularly.

Eligibility criteria:
inclusion criteria: * untreated pathologically confirmed inoperable stage iii nsclc according to the 8th edition of the american joint committee on cancer staging system; * at least one measurable disease by response evaluation criteria in solid tumors (recist)1.1; * 18-75 years of age; * eastern cooperative oncology group performance status score (ecog ps) of 0 to 1; * 10) fev1\>1.0 l; * suitable function of bone marrow, liver, kidney and coagulation exclusion criteria: history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses. -
non steroidal anti inflammatory treatment for post operative pericardial effusion

Conditions: Pericardial Effusion

Summary: the aim of the sudy is to evaluate, through clinical, biological and transthoracic echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (nsaid) drug (diclofenac)for this indication.

following cardiac surgery, the incidence of pericardial effusion (pe) is high (50-85%) . the risk of tamponade is well acknowledged : about 2%. we published in 2004 in chest a study which allows us to know the natural history of post-operative pe and to validate, for the first time the use of an echocardiographic classification for predicting the occurrence of a tamponade. nsaid are widely used in this setting, but no study has ever been conducted trying to assess their efficiency. the aim of the study is therefore obvious : must we use nsaid in order to prevent post operative cardiac tamponades ?. in order to answer this question, we are going to conduct a double-blind randomized study comparing diclofenac to a placebo. every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first tte (trans thoracic cardiac echography) a pe of severity \> 2 (that is to say about 10 % of the totality of the patients having undergone a cardiac operation) will be included.: after randomisation, patients will receive a placebo or diclofenac (50 mg ) bid, in a double blind way, during 14 days. trans thoracic cardiac echography, creatininemia, haemoglobinemia, international normalized ratio (for patients receiving a vitamin k antagonist) will be performed once a week during 2 weeks. clinical assessment will be done every day (there will be no outpatient primary end point : evolution of the mean echocardiographic score in each group -secondary end-points : number of tamponades number of patients in whom the individual echographic grade is decreasing of at least one point number of pericardiotomy creatininemia haemoglobinemia pe evolution in patients having an inflammatory syndrome (c reactive protein \>30) pe evolution in patients receiving a vitamin k antagonist 86 patients per group are necessary; therefore we will include a total of 200 patients

Eligibility criteria:
inclusion criteria: * -every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first tte (trans thoracic cardiac echography) a pe of severity \> or equal to 2 (that is to say loculated effusion \>10 millimeters or circumferential effusion \> 1 mm ) will be included exclusion criteria: * cardiac transplantation * age \ 80 * pregnancy * diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure...)

Keywords: post operative pericardial effusion nsaid
disturbed blood flow induces endothelial dysfunction in severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe copd patients.


Eligibility criteria:
inclusion criteria: * copd * chronic hypoxemia exclusion criteria: * an acute exacerbation, active respiratory infection or infection of other localisation 6 weeks prior to the visit * relevant coexisting lung disease such as interstitial lung disease, cancer, renal failure, thromboembolic disease or major cardiovascular event during the previous year * informed consent not provided or inability to comply with the study protocol
reducing the effects of active surveillance stress, uncertainty and rumination thru engagement in mindfulness education

Conditions: Prostate Cancer

Summary: we propose to examine the efficacy of couples-based mindfulness-based stress reduction (mbsr) on positive and negative psychological responses to active surveillance (as) and as adherence, with a sample of men on as and their spouses.

the current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (mbsr) on positive and negative psychological responses to active surveillance (as) and as adherence, with a larger, more geographically representative sample of men on as and their spouses. we will compare the mbsr intervention condition (group a) with a health promotion and wellness condition (group b) in a sample of prostate cancer patients and their spouses. we will evaluate its efficacy on self-reported measures of positive and negative psychological responses to as. primary aim examine longitudinal change in positive and negative psychological responses to as between groups over time. secondary aim observe the relation between positive and negative psychological responses to as and as adherence between groups over time. third aim explore dyadic factors on positive and negative psychological responses to as and as adherence between groups over time.

Eligibility criteria:
inclusion criteria: * must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance) * must be at least 18 years of age * must be able to read, write, speak and understand english * must be able to perform basic activities of daily living (as determined by referring physician) * must be cognitively intact and free of serious psychiatric illness (as determined by referring physician) * must have access to the internet and ability to locate the assessment url and/or ability to use a touchscreen keypad on a tablet device * must be willing to commit to the 8-week mbsr or health promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments * must be willing to complete study assessments exclusion criteria: * unable to provide consent * bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship

Keywords: prostate cancer active surveillance mbsr couples health promotion quality of life mindfulness
a comparison of the drug telbivudine (ldt) and lamivudine in adults with decompensated chronic hepatitis b and evidence of cirrhosis.

Conditions: Hepatitis B; Cirrhosis

Summary: this trial is being done to see if the investigational drug, ldt (telbivudine), is safe and effective in the treatment of hepatitis b infection. in addition to this, we will be looking at the comparison of the effects (good and bad) of ldt and lamivudine.

this study is a randomized, double-blinded trial looking at the drug telbivudine (ldt) and comparing it to the drug lamivudine in patients with chronic hepatitis b and evidence of cirrhosis. interested participants will first be seen for a screening visit, to determine eligibility for the study. participants will have a medical history taken along with a physical exam and a blood draw. prior to receiving the study drug, participants may be required to have a liver biopsy. if one was done in the past 5 years, it may be possible to use the results of the previous biopsy. if participants are unable to have a liver biopsy due to medical reasons, an ultrasound, ct, or mri scan may be done instead. if an imaging study has been done in the past two years, it may be possible to use the results from this test. all eligible participants will be put into one of two groups by chance (as in the flip of a coin). one group will receive 600 mg of ldt (3 tablets) plus a lamivudine placebo capsule (1 sugar pill) daily. while the other group will be receiving 100 mg of lamivudine (1 capsule) plus 3 ldt tablets (3 sugar pills) daily. participants will take the study drug daily for a total of 104 weeks (2 years). participants will return for clinic visits at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 52, 60, 68, 76, 84, 92, 100, and 104. participant's vital signs (temperature, pulse, weight) and blood samples will be collected at each visit. if after one year of being on the drug, there is no hepatitis b found in your blood, you may be stopped from the study drug. participants will continue to be required to return to the clinic for study visits so information can be continued to be collected and for your condition to be monitored. if future blood tests show that the hepatitis b virus returned, participants will be told to restart their study drug. at the end of the 104 weeks or if the treatment was stopped early for any reason except a liver transplant, or if additional treatment was not chosen for hepatitis b, participants will be asked to return to the clinic once every four weeks for 4 months. for each return visit to the clinic, vital signs and blood samples will be collected and recorded. a physical exam will be at the last follow-up visit. if the study was stopped due to a liver transplant, participants will be asked to return for clinic visits at 4 and 16 weeks after surgery. at these visits, no procedures will be done, but a review of the participant's medical record. participants will be involved for 2 years and 4 months.

Eligibility criteria:
patients with chronic hepatitis b with evidence of cirrhosis, who are at least 18 to 70 years old, may be eligible to participate in this study.