Kornimate/medical-research-clean huggingface dataset:
comparison of two anti-hiv regimens that include one of two forms of didanosine (ddi)

Conditions: HIV Infections

Summary: didanosine is an effective anti-hiv drug, but it can cause stomach upset. this study tests a new form of didanosine, ddi ec, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. the purpose of this study is to compare the effectiveness of ddi ec versus the standard form of ddi. both forms of ddi will be given with stavudine (d4t) plus nelfinavir (nlf).

patients are randomized to 1 of 2 open-label treatment groups. group 1 receives ddi ec plus d4t plus nlf for 48 weeks. group 2 receives ddi plus d4t plus nlf for 48 weeks. both forms of ddi are administered orally once daily. antiviral activity is determined by the magnitude and the duration of reduction of plasma hiv rna from baseline through week 24.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * are at least 18 years old. * have a viral load of at least 5,000 copies/ml and a cd4 count of at least 100 cells/mm3. exclusion criteria you will not be eligible for this study if you: * have received more than 4 weeks of treatment with nucleoside anti-hiv medications (nrtis), or more than 1 week with protease inhibitors. (all anti-hiv treatments other than study medications must be stopped at least 14 days prior to study entry.) * have severe diarrhea. * are pregnant or breast-feeding. * have a history of pancreatic disease or any other serious condition. * have hepatitis within 30 days prior to study entry. * cannot take medications by mouth. * have received certain medications.

Keywords: didanosine drug therapy, combination drug administration schedule stavudine hiv protease inhibitors nelfinavir reverse transcriptase inhibitors anti-hiv agents viral load
safety and clinical performance of a dialyzer with a modified polysulfone membrane

Conditions: Renal Failure; End Stage Renal Disease

Summary: the clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain ce-certification according to the european medical device directive for the fx coral 600 (td 16-1) dialyzer.

the fx coral (td 16-1) dialyzer is a new development with a modified polysulfone membrane and is not ce marked yet. the purpose of the clinical evaluation is to generate clinical data for the ce approval.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years * informed consent signed and dated by study patient and investigator / authorized physician * ability to understand the nature and requirements of the study exclusion criteria: * any condition which could interfere with the patient's ability to comply with the study. this decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.). * ongoing participation in an interventional clinical study during the preceding 30 days * previous participation in this study * pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period

Keywords: hemodialysis hemodiafiltration renal replacement therapy
buy 1 get 1: role of grocery coupons in promoting obesogenic home food environments and eating behaviors

Conditions: Obesity

Summary: the prevalence of overweight and obesity among older adults has reached an all-time high, which puts this age group at high risk for associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain forms of cancer. confronted with declining incomes and economic uncertainty, many middle-aged and older americans tried to save on their food purchases during the 2007-2009 recession. grocery coupons, available through newspapers, mail, and increasingly online, are one of several promotional tools that supermarkets and warehouse clubs use to promote sales. it is estimated that nationally 27% of households are frequent grocery coupon users who shop at a variety of retailers. despite the increasing popularity of grocery coupons, little is known about the extent to which they may promote obesogenic home food environments and eating behaviors. many coupons advertise the purchase of large quantities of prepackaged and processed foods and often reward shoppers by adding 'free' products if they purchase certain quantities. availability and easy accessibility of large portions of energy dense foods in the home has been shown to promote increased intake. the proposed study seeks to examine the effects of frequent grocery coupon usage on dietary intake, weight status, and home food availability among middle-aged and older adults. a second aim of this study is to test, in a randomized-controlled trial, the effects of incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in dietary intake, body mass index/waist circumference, home food availability, and grocery coupon use among frequent coupon users and non-coupon users.


Eligibility criteria:
inclusion criteria: * 40 - 70 years of age * frequent grocery coupon users * non-coupon users exclusion criteria: * dieting * medication use or medical conditions known to affect food intake and weight

Keywords: grocery purchases financial incentives obesogenic home food environment
metabolic and cardiovascular effects of renal denervation

Conditions: Insulin Resistance; Hypertension

Summary: renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. the mechanisms are however unclear. the investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.

renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. in addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. however, the mechanisms are unclear. there is a clear relationship between sympathetic overactivity and insulin resistance. activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. one possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). therefore,15 individuals undergoing renal denervation are recruited. the clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.

Eligibility criteria:
inclusion criteria: * essential hypertension * systolic blood pressure \>160 mm hg despite ≥3 antihypertensive drugs * clinical patients accepted for renal denervation exclusion criteria: * type 1 diabetes * pregnancy * glomerular filtration rate ≤45 ml/min/1,73 m2 * pacemaker/icd * myocardial infarction/stroke the last 12 months

Keywords: renal denervation hypertension insulin resistance adipose tissue function
the efficacy and safety of trapezius msat on acute whiplash injury

Conditions: Whiplash Injury of Cervical Spine; Neck Pain, Posterior

Summary: this study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment

motion style acupuncture treatment(msat) is a therapeutic technique using acupuncture needle created in jaseng hospital. this treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. this treatment is known to relieve the pain and increase the range of motion(rom). however, there has been no specific value for the effect of this treatment. so, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis msat. from july 2019 to september 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(nrs) over 4 after whiplash injury by acute traffic accident(ta). for experimental group(n=50), we conducted msat three times(on 2nd, 3rd and 4th day of hospitalization) and other korean medical treatment. for control group(n=50), just korean medical treatment except msat was conducted. for these two groups, we compared nrs, visual analogue scale(vas), range of motion(rom), nthe amount of pain via nrs(numeric rating scale), vas(visual analogue scale), rom(range of motion), neck disability index (ndi), and euroqol 5-dimension (eq-5d).

Eligibility criteria:
inclusion criteria: * patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident * patients with nrs ≥ 5 for posterior neck pain * patients aged 19-70 years on the date they sign the consent form * patients who provide consent to participate in the trial and return the informed consent form exclusion criteria: * patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc. * patients with progressive neurological deficits or with severe neurological symptoms * patients who have had surgery or procedures within the last three weeks * the cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc. * patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc. * patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study * if acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease * patients who are pregnant or planning to become pregnant * patients with a serious mental illness * patients who are participated in clinical trials other than observational studies without therapeutic intervention. * patients who are difficult to complete the research participation agreement * other patients whose participation in the trial is judged by a researcher to be problematic
stem cell therapy in mental retardation

Conditions: Mental Retardation

Summary: the purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.


Eligibility criteria:
inclusion criteria: * diagnosed cases of mental retardation * age above 6 months exclusion criteria: * presence of acute infections such as human immunodeficiency virus/hepatitis b virus/hepatitis c virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia

Keywords: mental retardation autologous mononuclear cell therapy stem cell
perioperative depression and postoperative arrhythmia in elective coronary bypass graft surgery

Conditions: Coronary Artery Disease

Summary: postoperative arrhythmias (heart irregularities) are one of the most common complications after cardiac surgery and are associated with increased morbidity and mortality. preoperative depression may be an important co-factor in the generation of postoperative arrhythmias due to sympathetic hyperactivity evident in patients with depression. objectives: to determine the effect of preoperative depression on postoperative arrhythmia in patients undergoing elective coronary artery bypass graft (cabg) surgery. prospective observational study, 120 patients undergoing elective cabg surgery ecg will be preformed preoperatively on all patients. all patients will be assessed for signs of depression using the prime md patient health questionnaire (prime md phq) one week before surgery and 6 weeks postoperatively.based on the prime md phq results, patients will be divided into two groups: those with or without signs of depression. heart rate and rhythm monitoring with holter will be performed for 3 days postoperatively in order to compare the incidence of postoperative arrhythmias between groups. the primary outcome is the number of patients with and without depression suffering from ventricular and/or supraventricular arrhythmias. secondary outcomes include all cause mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure. cabg surgery is the most common operative procedure in north america and arrhythmias are one of the most common postoperative complication. it is estimated that about a third of these cardiac patients suffer from preoperative depression and therefore may be exposed to a higher risk of perioperative morbidity and mortality. if an association between preoperative depression and postoperative arrhythmia is found, treatment modalities may be indicated to reduce the prevalence of perioperative arrhythmia in patients with preoperative depression undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * patients between 18-75 years of age undergoing elective cabg surgery. * patients must provide informed consent exclusion criteria: * patients with a history of arrhythmias (af, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, permanent pacemaker and/or defibrillator). * patients who are unable to read. * patients with significant psychiatric disorders other than depression. * patients with a history of pulmonary hypertension. * patients with a left ventricular ejection fraction \< 40%. * patients with cognitive impairment as measured by the mmse. * patients on antidepressants at the time of assessment

Keywords: arrhythmia depression coronary artery disease
efficacy and safety of octreotide (mycapssa™ [formerly octreolin™]) for acromegaly

Conditions: Acromegaly

Summary: mycapssa™ (formerly octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. this study will evaluate the efficacy and safety of mycapssa™ treatment in patients with acromegaly.

the study consisted of 2 periods, a core treatment period of up to 7 months and an optional extension treatment period of up to 6 months, for a total study duration of up to 13 months. the core treatment period consisted of 2 phases, a dose escalation phase of at least 2 months to identify the therapeutic dose for each study participant and a fixed dose phase of 2 to 5 months during which the therapeutic dose was maintained. participants were eligible to enter the fixed dose phase of the core treatment period if they were clinically and biochemically controlled. the same criteria were used to allow entry into the voluntary 6-month extension treatment period. the core treatment period of the study was completed if the participant had at least 2 months of treatment in the fixed dose phase and a total treatment duration of at least 7 months. participants who elected to continue into the extension treatment period maintained their therapeutic dose during this period. at the end of the study (after the last dose of mycapssa in either the core treatment period or the extension treatment period), there was a 2-week follow-up period for safety assessments.

Eligibility criteria:
inclusion criteria: * adult subjects, aged 18 to 75 years old, inclusive. * subjects with acromegaly defined as documented evidence of growth hormone-secreting pituitary tumor that is abnormally responsive to glucose, or documented elevated insulin-like growth factor-1 (igf-1), who are currently receiving a stable dose of a somatostatin analog for at least the previous 3 months. * a serum igf-1 level \< 1.3 x the upper limit of normal (uln) and a serum growth hormone (gh) level \< 2.5 ng/ml. * subjects able and willing to comply with the requirements of the protocol. * subjects able to swallow capsules. * subjects able to understand and sign written informed consent to participate in the study. exclusion criteria: * receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks. * symptomatic cholelithiasis. * received pituitary radiotherapy within ten years prior to screening. * undergone pituitary surgery within the prior 6 months. * any condition that may jeopardize study participation. * clinically significant gastrointestinal (gi), renal, or hepatic disease as determined by the investigator. * conditions (eg, bariatric surgery) significantly affecting gastric acidity or emptying. * current use (within 1 month) of proton pump inhibitors (ppis) and current chronic use of h2-antagonists. * female patients who are pregnant or lactating. * current or recent (\< 3 months) therapy with pegvisomant. * current or recent (\< 2 months) therapy with cabergoline.

Keywords: acromegaly igf-1 growth hormone octreolin octreotide somatostatin analog
a study of intraperitoneal and intravenous paclitaxel plus apatinib and s-1 conversion therapy for gastric cancer with positive exfoliative cancer cells

Conditions: Gastric Cancer With Positive Exfoliative Cancer Cells

Summary: the purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and s-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells


Eligibility criteria:
inclusion criteria: 1. untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); 2. age:18 to 70 years old; 3. man or female (except pregnant and lactating women); 4. confirmed to gastric adenocarcinoma; 5. proven gastric cancer of t stage was t3 and t4, and no distant metastasis was observed. the exfoliative cancer cells detection in peritoneal washes was positive; 6. blood cell count has to meet the following criteria: wbc≥3.5×109/l; anc≥1.5×109/l; plt≥100×109/l; hb≥90g/l; 7. liver/kidney function has to meet the following criteria: alt and ast≤2.5\*uln tbil\<1.5\*uln； serum creatinine ≤1.5\*uln; 8. eastern cooperative oncology group (ecog) performance status of 0-1; 9. participants were willing to join in this study, good adherence and written informed consent. exclusion criteria: 1. patients with other malignant tumors within 5 years; 2. metastasis was found to be visible to the naked eye; 3. it has serious or uncontrolled heart diseases and infections (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); 4. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. patients with severe or uncontrollable mental illness; 6. patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).has melena and hematemesis in two months; 7. pregnant or lactating women; 8. it have serious harm to the patient's safety or affect the patients who have completed the research. 9. the researchers think inappropriate.
pilot study of the osteo-fluidic-sensitive (ofs) in tension-type headache.

Conditions: Tension-Type Headache Episodic

Summary: the hypothesis of the study is the osteo-fluidic-senstive is effective for lowering headache pains (reduction of the number of days of headaches per month) for patients having frequent episodic tension-type headache. the ofs method will improve quality of life and will reduce the consumption of crisis treatments. compare the efficacy of the osteo-fluidic-sensitive method versus a placebo method on patients with tension type headache for the reduction of the number of days of headaches per month after 3 months of treatment at centre hospitalier universitaire de poitiers.


Eligibility criteria:
inclusion criteria: * 18 and 75 years' old * person having highly frequent episodic tension type headache (between 2 and 14 days of headaches per month) associated or not to headache with characteristic of a migraine per international classification of headache disorders 3rd edition criteria * person who completed his headache agenda the month before the study. * patient who understands and accepts the effects of the study * signed consent * person with health insurance coverage exclusion criteria: * person having secondary or primary headaches (chronic tension type headache, migraines only, cluster headaches, neuralgias ...) * person on treatment of venlafaxine, gabapentine, duloxetine, clomipramine et toxine botulique. * concomitant participation to another clinical research * pregnant or lactating women, women of child-bearing age who do not have effective contraception. * people with reinforced protection (juvenile), people deprived of liberty per justice or administrative decision, people living in a sanitary and social establishment, adults under legal protection and people in critical medical conditions