Kornimate/medical-research-clean huggingface dataset:
differential effect of four mindfulness exercises

Conditions: Well-being; Depression; Anxiety

Summary: mindfulness can be considered as a family of complex attentional and emotional regulation strategies that promote the cultivation of well-being and emotional balance. the practice of mindfulness produces the development of a consciousness that unfolds moment to moment, open and unprejudiced in the present moment, here and now. despite its extensive benefits, the practice of mindfulness requires a significant commitment in time and effort, which limits the potential for its dissemination. the studies to narrow the differential effects of the various exercises based on mindfulness, will further enhance their effectiveness and they can guide the practice sequence according to user needs. in this paper we will research mindfulness electroencephalographic correlates of as four different exercise programs included in mindfulness-based cognitive therapy (mbct) and stress reduction program based on mindfulness (mbsr) as well as its effect on several psychological variables.

mindfulness is a way of using attention intentionally, repeatedly reactivating the attentional focus, so that it enhances the ability of sustained attention. it involves a complex process of self-regulation and inhibition of internal and external stimuli interferences. although the overall effects of meditation on brain bioelectrical signals are still being characterized, there is some consensus on the fact that meditation helps alter brain activity in both state and trait. the specific aim of this study is to assess the differential effect of four different practices of mindfulness in psychological well-being and their corresponding neurophysiological correlates. the hypothesis is that different exercises within the range of mindfulness practices exert different effects in terms of electroencephalographic activity, expecting different band increases in alpha (activity 7-to 2 hz), beta (activity more than 13 hz), theta (activity 4-6 hz) and delta (activity less than 3 hz) respectively, as well as changes in the lateralization of the activity (left or right hemisphere). we also expect an improvement in the variables such as mindfulness, self-compassion, positive affect, anxiety, depression and sleep quality.

Eligibility criteria:
inclusion criteria: * sign of informed consent * no previous meditation training experience exclusion criteria: * mental or neurologic disorder * respiratory disease * previous brain damage history * medication intake that could interfere in the electroencephalographic results

Keywords: mindfulness meditation alpha rhythm eeg brain mapping emotion attention
a phase i study of lbh589 (panobinostat) in combination with external beam radiotherapy for the treatment of prostate cancer, esophageal cancer and head and neck cancer

Conditions: Prostate Cancer; Head & Neck Cancer; Esophageal Cancer

Summary: the purpose of this study is to assess the feasibility of combined administration of different lbh589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.


Eligibility criteria:
inclusion criteria: * patients with age ≥18 years * confirmed diagnosis of prostate cancer, scc esophageal cancer or head \& neck cancer * no evidence of distant spread of the disease exclusion criteria: * patients who have severe and/or uncontrolled medical conditions * female patients who are pregnant or breast feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: prostate, head & neck, esophageal
reliability of spasticity measurement with lokomat

Conditions: Spasticity, Lokomat

Summary: the purpose of the study is to evaluate the reliability of spasticity measurement with lokomat


Eligibility criteria:
inclusion criteria: * patients affected by lower limbs spasticity exclusion criteria: * medical contraindications to mobilization with lokomat
comparing misoprostol and oxytocin in uniject for postpartum hemorrhage (pph) prevention in senegal

Conditions: Postpartum Hemorrhage

Summary: this is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 iu oxytocin delivered by unijecttm intramuscularly during the third stage of labor

this study will assess the programmatic implications (including feasibility, acceptability, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in unijecttm for the prevention of pph and will help to identify the appropriate niche for both drugs.

Eligibility criteria:
inclusion criteria: * women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent exclusion criteria: * women with known contraindications to prostaglandins

Keywords: postpartum hemorrhage prevention misoprostol uniject oxytocin
concurrent chemoradiation with concomitant boost in locally advanced rectal cancer

Conditions: Rectal Neoplasms

Summary: neoadjuvant chemoradiation (crt), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.however, patients with t4 rectal cancer show high risk of local recurrence after conventional treatment. therefore investigators designed a prospective phase ii study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost rt (55 gy/5 weeks) with concurrent raltitrexed and oxaliplatin (tom-ox) chemotherapy.

neoadjuvant chemoradiation (crt), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival. however, patients with t4 rectal cancer show high risk of local recurrence (lr) after conventional treatment. this was a prospective phase ii study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost rt (55 gy/5 weeks) with concurrent raltitrexed and oxaliplatin (tom-ox) chemotherapy. the primary aim was to assess the pathological complete response rate. key secondary aim was the resectability. secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (os). the follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.

Eligibility criteria:
inclusion criteria: * histologically proven locally advanced (t4n0-2) or locally recurrent rectal adenocarcinoma; * age ≥ 18 years; * eastern eastern cooperative oncology group (ecog) performance status of 0-2. exclusion criteria: * metastatic patients * unfit surgery patients, * pregnant or breast feeding females * patients with clinically detectable ascites

Keywords: rectal cancer radiotherapy chemotherapy raltitrexed oxaliplatin
a study of the characteristics of patients diagnosed with recurrent symptomatic genital herpetic disease

Conditions: Genital Herpes; Patient Engagement

Summary: determine the baseline characteristics of patients who have recurrent symptomatic genital herpetic disease determine the acceptance to patients of clinical trial procedures determine interest in participation in genital herpes vaccine trials


Eligibility criteria:
inclusion criteria: * able to understand and willing to sign the informed consent document. * patient confirmation of a diagnosis of hsv-2 infection at least 2 years prior to inclusion. laboratory confirmation is not required. * symptomatic recurrent genital herpetic disease for \>2 years supported by compatible clinical history exclusion criteria: * subjects who do not meet the inclusion criteria for the study * subjects who are unable to provide legally effective informed consent
brain computer interface and virtual reality (bci-vr) for pain treatment

Conditions: Neuropathic Pain

Summary: pilot interventional study with minimal risks and constraints, prospective, monocentric. safety and efficacity evaluation of a novel medical device.

upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly due to maladaptive cns (central nervous system facility) plasticity and thus could be decreased by retraining the sensorimotor cortex using mental motor imaging guided through a novel bci-rv feedback system : "ghost". the aim of this study is to evaluate safety and efficacy of this bci pain treatment developed by our team.

Eligibility criteria:
inclusion criteria: * neuropathic pain / phantom limb pain * mean pain score \>3 centimeter * permanent pain * if plexus brachial injury : \> 6 month * if amputation : at least at wrist level * motor and sensory deficit : complete or incomplete * informed consent * public health insurance exclusion criteria: * mri contraindication * subject included in another interventional study * pregnant women * majors under guardianship or curatorship or safeguard of justice * history of associated head injury or any other neurological pathology altering the sensorimotor cerebral system or cognitive abilities and higher functions. * presence of other lesions of the peripheral nervous system that may induce associated neuropathic pain. * head trauma associated altering somatosensory system or cognitive abilities and higher functions
safety and immunogenicity of a melan-a vlp vaccine in advanced stage melanoma patients

Conditions: Malignant Melanoma

Summary: the purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a melan-a vlp vaccine.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent. * able and willing to complete all protocol requirements. * age: 18 years and older. * histological confirmed stage iii or iv melanoma. * at least one confirmed detectable target lesion * hla-a\*0201 haplotype * expected survival of at least 6 months. * full recovery from surgery. * able to undergo either ct scan or mri scan for tumor assessment. * wash-out period of 4 weeks after chemotherapy * all aes form prior anticancer therapy have resolved to ≤ grade 1. * sexually active males should use adequate contraception throughout the study period and 3 months thereafter. * females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine. exclusion criteria: * pregnant or nursing. * use of an investigational drug within 30 days before enrolment. * known or suspected brain metastases. * current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug * presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders * serum tests positive for hiv, hbv, hcv. * active autoimmune diseases or severe allergies. * current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study. * abuse of alcohol or other recreational drugs. * previous vaccination with a melan-a analog peptide.
a mechanistic evaluation of the interactions between thermoceptive and pruriceptive sensory processing

Conditions: Itch; Thermal Stimulation; Histamine; Cowhage; Serotonine

Summary: the purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.


Eligibility criteria:
inclusion criteria: * healthy men and women * age 18-60 years * able to speak and understand english exclusion criteria: * suffering from chronic disease * pregnancy or lactation * prior experience of adverse effects from anaesthetic, specifically lidocaine * drug addiction defined as the use of cannabis, opioids or other drugs - 5 - * previous neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * current use of medications that may affect the trial * active skin diseases * active participation in other experiments currently ongoing or within the last 14 days * tattoos on volar forearms that will interfere with local skin measurements
brainsway dtms for treatment of mdd using itbs

Conditions: Major Depressive Disorder

Summary: the safety and effectiveness of the brainsway deep transcranial magnetic stimulation (dtms) device for the intended use of major depressive disorder (mdd) using the intermittent theta-burst (itbs) stimulation protocol will be evaluated in a non-inferiority study, comparing the itbs treatment with the fda cleared, (510(k) no. k122288) brainsway dtms device to the high frequency (hf) protocol using the same device.

the purpose of the study is to evaluate the safety and efficacy of brainsway deep tms for the treatment of major depressive disorder using the itbs stimulation protocol, by comparing it to clinical data collected in the brainsway randomized, controlled multicenter study (ctp-001-00), using the hf dtms stimulation protocol used in support of the brainsway dtms device 510(k) k122288. in the post-marketing study, patients will be treated with an intermittent theta burst (itbs) protocol, using the same brainsway dtms device with the same h1-coil. furthermore, the treatment paradigm is the same, consisting of tms sessions performed daily for 5 weeks (20 dtms sessions). the itbs stimulation protocol consists of bursts of 3 pulses at 50 hz, 5 hz bursts frequency, 2s on and 8s off, 600 pulses per session. the hf stimulation protocol was delivered at 18 hz, 120% stimulation intensity of the resting mt, 55 trains of 2s duration, inter-train interval (iti) of 20s, for 1980 pulses per session. the clinical study design includes multiple measurements of safety and effectiveness parameters. the primary outcome measure is the change from baseline in hdrs-21 scores at the 5 week visit (after 20 treatment sessions). the success criteria of the study is a non-inferiority margin of 3.0 points. the secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on hdrs-21 scores, at the 5 week visit, change in cgi-s score from baseline to 6 weeks and response and remission rates based on cgi-s scores at the 6 week visit. safety will be assessed at each treatment visit. patients will be asked to report any adverse event since their previous visit.

Eligibility criteria:
inclusion criteria: * outpatients * diagnosis of major depression disorder exclusion criteria: * other significant axis i psychiatric disorder with greater impairment than mdd

Keywords: intermittent theta burst stimulation itbs depression
relation between carotid atheroscerosis with dm &fatty liver

Conditions: Atherosclerosis With Diabetes Mellitus and Fatty Liver

Summary: to determine the risk of atherosclerosis in nafld patients who have t2dm by meauring carotid intima media thickness (cimt) using carotid doppler ultrasound.

fatty liver is one of the most common chronic liver diseases in the world. it's prevalence is reported to be 10-40% in the adult populations. at least 57% to 80% of them are associated with diabetes (1.2).atherosclerosis and cardiovascular diseases are also highly prevalent in this group of patients(10). non-alcoholic fatty liver disease ( nafld) is characterized pathophysiological by hepatic fat accumulation independent of excessive alcohol use(3.4). fatty liver index (fli) has been demonstrated good diagnostic accuracy in different populations(6.7)...fli will be based on bmi, waist circumference (wc), triacylglycerols (tg) and g-glutamyl transferase (ggt). the individuals with nafld have a higher risk of 10-year cardiovascular events than healthy individuals.(10) .nafld and t2dm are common conditions that regularly co-exist and can act synergistically to drive adverse outcomes(5). diabetic macrovascular complications are the major chronic complications and the leading cause of death among the patients with t2dm, of which the pathological basis is atherosclerosis.(8) atherosclerosis usually starts in the vascular intima, progressing to the medial arterial wall(9).carotid intima-media thickness (cimt) is an indicator of the risk of vascular disease. increased cimt and presence of atherosclerotic plaque are considered as a reliable ultrasound biomarker of subclinical atherosclerosis and can be used for cardiovascular risk assessment\[9\]. in this study the investigators have the aim of evaluating the possible association between non-invasive index of fatty liver (fli) and the presence of carotid atherosclerosis in t2dm.

Eligibility criteria:
inclusion criteria: * patients with fatty liver (diabetic\& not diabetic). exclusion criteria: * 1-other causes of liver disease ( (viral hepatitis, drug-induced liver disease, hepatolenticular degeneration, autoimmune liver disease, schistosomiasis liver disease, cirrhosis, etc.) 2- heavy smoker.
oxidative stress markers and cardiac resynchronization therapy (crt) outcomes

Conditions: Congestive Heart Failure

Summary: this is a research study that is evaluating blood markers which may predict which patients who receive crt will improve. congestive heart failure (chf) is associated with increased oxidative stress, a condition where abnormal oxygen forms are produced. these forms harm the cells of the heart and cause damage to the heart muscle. we would like to see if blood levels of these forms improve after crt, and if they can be measured early after surgery to predict who will and who will not benefit from surgery.

congestive heart failure (chf) is a common diagnosis with significant clinical impact. although medical therapy exists, many patients on optimal medical treatment are still highly symptomatic. about 1/3 of these patients have a condition known as "dyssynchrony", where the walls of the heart beat in an uncoordinated way, causing worsening of chf symptoms. a newer therapy known as cardiac resynchronization therapy (crt) has been successful in decreasing symptoms in these dyssynchronous patients. it involves surgical placement of a pacemaker containing 3 wires- one in the top part of the heart (atrium) to coordinate the top and bottom parts of the heart beat, and two on the bottom to coordinate the bottom parts of the heart beat (ventricles). this treatment, however, does not work for up to 1/3 of patients with dyssynchrony. recent studies have found that chf is associated with increased oxidative stress. this is a condition where abnormal oxygen forms are produced. these forms harm the cells of the heart, causing them to beat abnormally and causing damage to the heart muscle. we would like to see if levels of these forms improve after crt, and if they can be measured early after surgery to predict who will and who will not benefit from surgery. in this study, we will compare blood markers of oxidative stress between patients with chf and an already-collected set of control patients to confirm these levels are elevated at baseline. then, we will perform crt surgery and implant pacemakers in the chf patients. at 1 week and 3 months postoperatively, we will measure blood markers again, and see if they have improved in patients whose symptoms have improved. patients will undergo echocardiograms to document their abnormal hearts, do a 6 minute hall walk to measure their exercise tolerance, and take a standardized questionnaire to measure their symptoms of chf. these test results will be compared pre and post crt to assess response to therapy.

Eligibility criteria:
inclusion criteria: * screen for enrollment criteria, * consented, * echocardiogram and electrocardiogram performed, * demographics reviewed, * obtain blood sample, * pre-operative qol questionnaire. exclusion criteria: * 6 minute hall walk.

Keywords: cardiology cardiomyopathy cardiovascular disease cardiac resynchronization therapy (crt)
evidence-based nutrition practice guidelines of toolkit and preliminary outcomes

Conditions: Type 2 Diabetes Mellitus

Summary: the goal of this study is to field test ada's type 2 diabetes evidence-based nutrition practice guidelines (ebnpg) for adults in 2008 as a tool for registered dietitians (rds) for their patients with with type 2 diabetes who have no evidence of organ damage. a six month pilot study will be conducted to determine the feasibility of training rds in documenting the outcomes of implementing medical nutrition therapy (mnt) using ada's evidence-based gl for t2d.


Eligibility criteria:
inclusion criteria: * over 19 years * no documented claims for the treatment of td over the past 7 years * no mnt claims submitted within the past 12 months * not under rd care * able to make visits to the clinic per guidelines exclusion criteria: * not in end-stage renal disease or renal insufficiency; history of cardiovascular disease,chronic athrosclerotic disease, or myocardial infection; chronic obstructive pulmonary disease, untreated depression, severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment; congestive heart failure. * pregnant or lactating at time of study * presence of cognitive limitations that preclude making lifestyle or dietary changes as assessed by the rd during the initial interview
clinical trial to investigate the effectiveness of a dietary supplement in increasing libido and sexual function in postmenopausal women.

Conditions: Female Sexual Arousal Disorder

Summary: this clinical trial will assess the effects of a dietary supplement based on tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the fsfi scale and different variables during 3 months period. participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).


Eligibility criteria:
inclusion criteria: * women who report decreased libido and present female sexual arousal disorder according to diagnostic and statistical manual of mental disorders (dsm-v) criteria * post-menopause. * age between 45 and 65 years. * sexually active. * agreement to participate and to sign the informed consent documents. exclusion criteria: * pregnancy. * women who are on hormone replacement therapy or who need to start it. * cancer treatment or a recent history of cancer (\<2 years). * any of the following treatments: serotonin inhibitors, gabaergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible) * fibromyalgia. * treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.). * any comorbidity that may interfere with the pathology under study.