Kornimate/medical-research-clean huggingface dataset:
exercise and vascular function in haemodialysis patients

Conditions: Chronic Kidney Disease Stage 5

Summary: the aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.

life expectancies in haemodialysis patients are significantly shorter than the general population due to higher cardiovascular disease risk. this is mediated by higher prevalence of cardiovascular risk factors associated with chronic kidney disease and the haemodialysis procedure. consequently ageing of the arterial system is accelerated in this condition leading to higher prevalence of arterial plaques and increased arterial stiffness. higher physical activity and fitness are associated with lower cardiovascular disease and all-cause mortality in haemodialysis patients and the general population. moreover, physical inactivity is associated with increased arterial stiffness and plaques which narrow heart arteries. worryingly the haemodialysis population is on average highly inactive with low fitness. current research demonstrates that exercise which improves fitness improves arterial health. increased bloodflow during exercise stimulates the release of nitric oxide causing arteries to dilate. regular exercise is believed to lead to beneficial remodelling of arteries and lower arterial stiffness. exercise is reported to improve arterial function across a range of conditions. however published research regarding the possible benefits of long term aerobic exercise on arterial health in this population is conflicting. limitations in study design, moderately high participant dropout rates and low statistical power hamper a definitive conclusion. importantly a gold standard measure of arterial function has not been used in previously published studies. there is ample evidence that exercise programmes in people on dialysis improve fitness, physical function, and quality of life. it is also clear that a state of higher physical activity and fitness is associated with better arterial function in the general population. it would be advantageous for reasons of health counselling to determine whether the process of improving physical fitness and activity levels may also improve arterial health in haemodialysis patients.

Eligibility criteria:
inclusion criteria: * stage 5 ckd patients (gfr \<15 ml/min) receiving maintenance haemodialysis therapy * male or female * aged \>18 years * written informed consent exclusion criteria: * pregnancy * unstable cardiovascular conditions * recent cerebrovascular event * excess inter-dialytic weight gain * use of corticosteroids, anabolic therapies, * co-morbid catabolic conditions * serum potassium regularly \>6mmol/l * recent pulmonary thromboembolism * psychiatric illness including anxiety, mood and untreated eating disorders * infection or course of antibiotics within one month of study period. * dementia or severe cognitive impairment.

Keywords: exercise kidney disease vascular function haemodialysis
comparative mechanisms of psychosocial chronic pain treatments

Conditions: Chronic Low Back Pain

Summary: psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. however, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about how our treatments work. it may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.


Eligibility criteria:
inclusion criteria: * significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months * musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory) * age between 18 and 75 years. exclusion criteria: * meet criteria for alcohol or substance abuse problems * meet criteria for past or present psychotic or bipolar disorders * inability to understand english well enough to complete questionnaires or to participate in therapy * active suicidal ideation with intent * pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.

Keywords: chronic low back pain psychosocial interventions mechanisms
pueraria lobata and pueraria thomsonii for mild dyslipidemia

Conditions: Dyslipidemias

Summary: dyslipidemia is an important risk factor for atherosclerotic cardiovascular disease. maintaining normal levels of lipid indicators can significantly reduce the risk of atherosclerotic cardiovascular disease and mortality. empirical evidence suggests that adherence to pueraria lobata and pueraria thomsonii is useful for improving dyslipidemia, but evidence from randomized controlled trials is lacking. this randomized, double-blind controlled trial is therefore designed to evaluate the efficacy and safety of pueraria lobata and pueraria thomsonii for dyslipidemia.

pueraria is an important chinese herbal medicine. the pharmacopoeia of the people's republic of china classifies the pueraria as pueraria lobata and pueraria thomsonii according to the different sources of the plant, both of them is sweet, pungent and cool in nature, and has the effects of relieving fever, quenching thirst, penetrating rashes, raising the yang to stop diarrhea, activating the meridians and detoxifying alcohol. as early as in the han dynasty, zhongjing zhang's "treatise on febrile diseases" described the famous formula "pueraria tang", which is still an important formula for relieving exterior syndromes. in clinical practice, the preparations of pueraria lobata and pueraria thomsonii are widely used to treat headache, dizziness, hypertension, coronary heart disease, angina pectoris, myocardial infarction and other diseases. for example, the puerarin injection has the effects of dilating blood vessels, slowing down heart rate, reducing myocardial oxygen consumption and improving blood circulation in the heart and brain. although the puerarin has been shown to be effective in a variety of cardiovascular diseases, as of now, it is unclear whether pueraria lobata and pueraria thomsonii can be used as part of the daily diet to regulate blood lipids and improve dyslipidemia. therefore, the aim of this study is to conduct a randomized, double-blind controlled trial that includes patients with mildly elevated lipids to evaluate the efficacy and safety of pueraria lobata and pueraria thomsonii for dyslipidemia.

Eligibility criteria:
inclusion criteria: * marginally elevated low-density lipoprotein (ldl-c), 3.4 to 4.1 mmol/l * informed consent to the study and signed the informed consent form exclusion criteria: * patients who have a history of allergy to pueraria lobata or pueraria thomsonii. * patients who have taken lipid-lowering drugs within a week * patients with secondary dyslipidemia caused by other diseases or medications taken. * pregnant or lactating women. * patients who combine cognitive dysfunction, disorders of consciousness, psychiatric disorders, dyslexia or verbal communication dysfunction * patients with a combination of other serious diseases, such as malignant tumors, hepatic or renal insufficiency, cardiovascular or cerebrovascular disease, etc.

Keywords: dyslipidemias, pueraria lobata, pueraria thomsonii
advancing postmenopausal preventive therapy

Conditions: Atherosclerosis; Cognitive Decline

Summary: advancing postmenopausal preventive therapy (appt) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (tsec) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.

to conduct a double-blinded, placebo-controlled trial to determine the effects of tsec therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. a total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to bazedoxifene/conjugated equine estrogen (bza 20 mg/ce 0.45 mg) or placebo. recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. rate of change in carotid artery intima-media thickness (cimt) determined from the distal common carotid artery (cca) far wall intima-media thickness (imt) in computer image processed b mode ultrasonograms will be the primary trial endpoint. arterial stiffness measured from the cca (same location as cimt) in computer image processed b mode ultrasonograms will be the secondary trial endpoint. three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.

Eligibility criteria:
inclusion criteria: * women with a serum estradiol level \ 6 months who are \<6 years postmenopausal and 45-59 years old. exclusion criteria: * women with a hysterectomy * clinical signs, symptoms or personal history of cardiovascular disease * diabetes mellitus or fasting serum glucose \>126 mg/dl * life threatening illness with prognosis \<5 years * cirrhosis or liver disease * history of deep vein thrombosis or pulmonary embolism * history of breast cancer * current use of postmenopausal hormone replacement therapy (hrt) within 1 month of randomization * uncontrolled hypertension (\>180/\>110 mmhg)\* * plasma triglyceride levels \>500 mg/dl * serum creatinine \>2.0 mg/dl
nasal high flow therapy in surgical patients with unrecognized obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing

Summary: in this study the investigators will determine whether using high flow oxygen in moderate-to-severe obstructive sleep apnea patients following a major non cardiac surgery is more efficacious than usual care in preventing decrease in oxygen level in blood.

the posa-ii trial is a culmination of the investigator's program of research to prevent postoperative adverse outcomes in surgical patients with untreated obstructive sleep apnea (osa). it is a multi center open label, randomized clinical trial of nasal high-flow vs. usual care in patients with untreated moderate-to-severe osa undergoing major non cardiac surgery. it is a proof of concept trial to show that nasal high-flow reduces severe desaturation, the causal mechanism for osa-related adverse events, and to collect key feasibility data for a large international multi center trial with enough power to detect effects on the clinical outcomes. eligible patients undergoing major non cardiac surgery with high-risk osa will have a home sleep study. one hundred and ninety patients with moderate-to-severe sleep apnea will be randomized into either nasal high-flow or usual care group. sleep studies, oximetry, electrocardiogram (ecg), and troponin will be done preoperatively. postoperatively, ecg and troponin will be determined daily for the 1st three days, and nocturnal oximetry for the 1st 3 nights. patients will be followed during their hospitalization and for 30 days postoperatively to ascertain any adverse outcomes. a blinded clinical events committee will adjudicate all components of the composite outcome.

Eligibility criteria:
inclusion criteria: * adult, age ≥45 years, undergoing major elective non cardiac surgery under general and/or regional anesthesia with anticipated overnight stay or longer in hospital * patients with untreated moderate-to-severe obstructive sleep apnea. * stop-bang score 5 or higher exclusion criteria: * predetermined need for postoperative cpap therapy or ventilation, * cheyne-stokes respiration or central apnea, * oxygen dependent due to moderate to severe chronic obstructive lung disease available forced expiratory volume at 1 second of \< 50% predicted) or advanced interstitial lung disease, * pre-existing chronic hypercapnia or obesity hypoventilation syndrome, intracranial and otolaryngological procedures, and * unable to use nasal high-flow (nasal/oral malformations, pre-existing tracheostomy, planned postoperative nasal packing).

Keywords: sleep apnea
a prospective, open label, dose-escalation, sad/mad, multicenter, 24weeks, phase i/iia clinical trial to evaluate the safety, tolerability and pharmacodynamics of investigational product (vm-001) in patients with graft-versus-host disease(gvhd)

Conditions: Graft Versus Host Disease

Summary: the present study is multi center, phase i/iia clinical trial to evaluate the safety and pharmacodynamics of investigational product (vm-001) in patients with graft-versus-host disease(gvhd). a total of 12 subjects (part 1 sad\[3 cohort(2 subjects/cohort)\], part 2 mad\[2 cohort(3subjects/cohort)\]) are recruited.


Eligibility criteria:
inclusion criteria: * men and women ≥19 years of age * acute gvhd or chronic gvhd after hematopoietic stem cell transplant * subjects who no longer have available standard treatment. * anc≥1,000cells./mm\^3 * ast, alt, total bilirubin less than 3 times the upper limit of normal * serum creatinine less than 1.5 times the upper limit of normal exclusion criteria: * received an anti-thymocyte globulin(atg) within 14 days before enrollment * fcv or fev less than 70% * any uncontrolled infection or active infection requiring ongoing systemic treatment * received an investigational agent within 6 months before enrollment. * evidence of bleeding diathesis or coagulopathy. * active hepatitis c virus (hcv) or hepatitis b virus (hbv) * breastfeeding or pregnant.
focused ultrasound in septic shock patients

Conditions: Septic Shock

Summary: the investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. septic shock patients from multicenter will be enrolled in the study. they will be randomly divided into two groups. the routine treatment group will receive routine treatment according to the ssc guideline. the study group will receive additional ultrasound examination, which will decide the improvement of therapy. therapy change based on ultrasound results and the prognosis will be recorded.


Eligibility criteria:
inclusion criteria: * age\>18yr * survive more than 24hrs * fulfilled septic shock exclusion criteria: * age \< 18yr * pregnant * dnr

Keywords: critical ultrasound
the interaction between oxytocin and serotonin

Conditions: Healthy

Summary: the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fmri design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (atd, versus placebo)

convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. evidence is emerging that both systems interact in this domain. to determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (oxytocin nasal-spray and acute tryptophan depletion, atd) and their combination within a pharmaco-fmri experiment. to determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24iu) versus placebo and atd (75.2g) versus placebo before fmri measures of emotion perception and resting state will be acquired. to control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

Eligibility criteria:
inclusion criteria: * health subjects without past or current psychiatric or neurological disorders * right-handedness exclusion criteria: * history of head injury; * medical or psychiatric illness. * high blood pressure, general cardio-vascular alterations * history of drug or alcohol abuse or addiction. * allergy against medications or general strong allergies * sleep disorders. * visual or motor impairments

Keywords: oxytocin acute tryptophan depletion emotion
high-intensity intermittent training for obese individuals

Conditions: Obesity

Summary: the most appropriate and effective exercise interventions for weight loss remain a matter of continued discussion and there is a need to identify sustainable exercise programs which successfully promote weight loss and benefit health. the primary objective of this study is to determine if high-intensity intermittent sprinting (hiis) produces better results in terms of reducing metabolic and cardiovascular risk factors, with special emphasis to fat mass loss and insulin sensitivity in "healthy" obese volunteers compared with an iso-caloric program of moderate-intensity continuous cycling (micc) (control condition following the international recommendations). we will also assess the impact of short duration sprints (sds) in the above factors and to understand the potential mechanisms behind different outcomes among training programs. the overall hypothesis is that hiis will lead to a greater reduction in metabolic and cardiovascular risk factors compared with micc in healthy obese volunteers and that sds will produce similar improvements in cardiovascular risk factors as the longer duration hiis

participants will be randomized to one of three groups: hiis (8s sprint:12s rest) or micc (control group) iso-caloric protocols (for the duration needed to induce a 250 kcal energy deficit) or sds (8s sprint:12s rest) for 10 minutes for 12 weeks. the intervention groups will be matched for age, bmi and male/females ratio and participants will be asked not to change their normal diet throughout the study. before and after the exercise intervention (12 weeks), participants will perform the following assessments: 1. three-day food diaries 2. anthropometric measurements (weight, height, waist and hips) using standard procedures; 3. body composition using dual energy x-ray absorptiometry (dexa) 4. rmr and resting respiratory exchange ratio (rer) using indirect calorimetry; 5. endothelial function assessed by flow-mediated dilation (fmd) of the brachial artery using vascular ultrasound according to current guidelines; 6. maximal oxygen uptake (vo2max) and fat oxidation, cardiac output and left ventricular function during exercise using a cycle ergometer; 7. muscle and fat biopsies 8. fasting and postprandial release of appetite related hormones (and subjective feelings of hunger/fullness using visual analogue scales - vas).

Eligibility criteria:
inclusion criteria: * weight stable on the last three months, * not currently dieting to lose weight * inactive lifestyle. exclusion criteria: * history of endocrine/cardiovascular/pulmonary/kidney disease, * anaemia, * gout, * depression or other psychological disorders, * eating disorders, * drug or alcohol abuse within the last two years * current medication known to affect appetite or induce weight loss. * planned surgery during the study period * participation in another research study * restraint score derived from the tfeq\>12 * post-menopausal women

Keywords: obesity exercise body composition insulin sensitivity appetite food intake
hsv-2 suppression to reduce hiv-1 levels in hiv-1, hsv-2 co-infected men.

Conditions: HIV Infection; Herpes Simplex; Sexually Transmitted Diseases

Summary: over 80% of hiv-1 infected persons are also seropositive for hsv-2. increasingly, clinical and epidemiologic evidence show the role of hsv in increasing hiv infectiousness. the evidence suggests that that hsv is an important cofactor in hiv transmission. the trial's purpose is to assess the reduction in hiv shedding associated with valacyclovir for suppression of hsv-2 reactivation. this proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 hiv/hsv-2 co-infected men, assessed the effects of daily valacyclovir on hiv-1 levels in the plasma and rectal mucosa secretions.

herpes simplex virus type 2 (hsv-2) is common among hiv infected persons. hsv-2 reactivation is associated with increased plasma and genital hiv-1 levels, and in vitro, hsv-2 upregulates hiv transcription. the trial assessed whether hsv-2 suppression reduces rectal and plasma hiv-1 levels in hiv-1, hsv-2 co-infected men who have sex with men (msm). conducted in lima peru, 20 antiretroviral naive hiv-1 and hsv-2 seropositive msm with cd4 \>200 were randomly assigned to receive valacyclovir 500 mg bid or placebo for 8 weeks, than a 2 week washout period, followed by the alternative regimen for 8 weeks. men collected daily home anogenital swabs for hsv dna pcr, had three weekly anoscopy procedures for collection of rectal mucosal secretions for hiv-1 rna, hsv dna, and weekly plasma hiv-1 rna by pcr. outcomes were plasma and rectal hiv-1 levels by study arm.

Eligibility criteria:
inclusion criteria: * greater than 18 years old, * documented hiv-1 seropositive, * cd4 count greater than 200, * not on hiv antiretroviral therapy, * hsv-2 seropositive as determined by focus eia (in \>3.5) * not intending to move out of the area for the duration of study participation. * willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule. * bacterial stds (symptomatic std syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment. exclusion criteria: msm who meet any of the following criteria are not eligible for this study: * known history of adverse reaction to valacyclovir, acyclovir or famciclovir; * planned open label use of acyclovir, valacyclovir, or famciclovir * known medical history of seizures * known renal failure, serum creatinine \>2.0mg/dl * hematocrit \< 30 %

Keywords: hiv infection hiv shedding hsv suppression co-infected msm reactivation valacyclovir