Kornimate/medical-research-clean huggingface dataset:
a double-blind study of buprenorphine treatment of acute suicidality

Conditions: Depression; Suicidal Ideation; Suicidal Action

Summary: the acutely suicidal patient presents a complex and dangerous clinical dilemma. many suicidal patients receive antidepressant medications, but the onset of action of these medications is at least three weeks, and despite their established antidepressant effect, they have not shown a clear anti-suicidal benefit. psychoanalysts hypothesized that depression (often leading to suicidality) shares important characteristics with the psychological sequellae of object loss and separation distress. endogenous opioids (endorphines) have been implicated in mediating social bonding and separation distress in mammals. anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective antidepressant with a rapid onset of action. it is therefore hypothesized that buprenorphine may be a novel and quick-acting treatment for acute suicidality, especially in the context of depression. the proposed double-blind study will examine the effect of buprenorphine on acutely suicidal inpatients. depression, suicidality, and overall functioning will be assessed before, during and after a two-week buprenorphine/placebo trial. a small subgroup of patients will also be treated with short-term psychoanalytic psychotherapy throughout the study period. it is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of suicidality and depression.


Eligibility criteria:
inclusion criteria: * depression exclusion criteria: * substance or alcohol abuse * psychosis

Keywords: depression suicidality buprenorphine
study of the hummingbird tts™ tympanostomy tube system

Conditions: Otitis Media

Summary: the objective of this study was continued commercial evaluation of the intraoperative safety and performance of the h-tts for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

the study was a multi-site, prospective and retrospective, treatment-only post-market study of the h-tts. the study was performed in a commercial environment. patients were already have a scheduled tympanostomy procedure with the h-tts under moderate sedation and local anesthetic.

Eligibility criteria:
inclusion criteria: * age 6 months through 5 years of age * candidates for ventilation tube placement * h-tts used under moderate sedation and local anesthetic

Keywords: tympanostomy myringotomy otitis media ear tubes ear infection
dynamx bioadaptor hong kong registry

Conditions: Coronary Artery Disease

Summary: prospective, non-randomized, multicenter registry

enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and\<=34 mm in length receiving the dynamx novolimus eluting coronary bioadaptor system (css), with primary, interim clinical follow-up via telephone at 1 month. follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Eligibility criteria:
inclusion criteria: 1. subject age ≥ 18 and ≤ 80 years 2. subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment 3. indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-st-elevated myocardial infarction) 4. vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion 5. all lesions requiring pci should be amendable for implantation with the study stent 6. successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being \< 35% exclusion criteria: 1. target lesion / vessel specific 1. lesions in the left main 2. venous or arterial bypass grafts 3. in-stent restenosis 4. chronic total occlusion 5. ostial lesions (\< 3 mm from the ostium of the rca, lad or cx) 6. stent implanted \< 10 mm from the target lesion in the previous 30 days. 7. lesion requiring rotablation or atherectomy because of, but not limited to severe calcification 8. bifurcation lesions requiring a planned 2 or more stent technique 2. patient specific: 1. stemi 2. acute myocardial infarction with killip class iii and iv 3. known lvef \< 30% 4. life expectancy \< 1 year 5. patients on renal dialysis or known gfr \< 30 ml/min 3. planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months 4. known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy) 5. subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin) 6. subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint 7. known pregnancy or breastfeeding 8. subject is in the opinion of the investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason

Keywords: drug eluting stent percutaneous coronary intervention
study evaluating single ascending doses of aab-001 vaccine sad japanese patients with alzheimers disease

Conditions: Alzheimer Disease

Summary: evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational aab-001 vaccine in japanese patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of ad * age 50-85 * mmse 14-26 * other inclusion criteria apply exclusion criteria: * significant neurological disease * major psychiatric disorder * clinically significant systemic illness * other exclusion criteria apply
comparison of left ventricular volume and wall stress with dobutamine and exercise echocardiography

Conditions: Ischemia; Angina

Summary: this study will compare the physiologic responses between exercise stress echocardiography and pharmacologic stress echocardiography on left ventricular volume and wall stress.

this prospective observational study will compare the physiologic responses between exercise stress echocardiography and dobutamine stress echocardiography on left ventricular volume and wall stress. exercise and dobutamine stress testing are two widely employed diagnostic modalities that are often used, interchangeably, to detect inducible ischemia. we hypothesize that dobutamine leads to significantly lower ventricular volumes and wall stress than exercise. some previous studies have shown that dobutamine and exercise echocardiography have comparable sensitivities and specificities, differences exist between the hemodynamic effects produced by each modality on the cardiovascular system. these variable effects may lead to differences in left ventricular size, volume and wall stress. if divergent left ventricular effects exist(between exercise and dobutamine induced stress), then the degree of myocardial oxygen consumption, ischemic burden, and ischemic threshold observed during exercise and dobutamine stress testing may be different between these commonly used modalities of stress testing. the potentially variable effects on the left ventricle in response to the modality used to induce stress would highlight a physiological difference between exercise and dobutamine stress testing. differences in volumes and stress could also help explain the greater of ischemia and higher frequency of angina and st-segment deviation which has been previously observed in some studies during exercise as compared to dobutamine echocardiography. the presence or lack of these expected hemodynamic responses may also have additional diagnostic and prognostic implications. the study involves the collection of data among patients undergoing stress echocardiograms that are clinically indicated. this data will be retrieved from the echocardiogram and report and medical chart, including baseline clinical characteristics, exercise parameters achieved during the test.

Eligibility criteria:
inclusion criteria: * age 30-80 years * normal sinus rhythm on electrocardiogram * normal left ventricular systolic function on baseline echocardiogram exclusion criteria: * patients with stress-induced wall motion abnormalities * left ventricular hypertrophy * evidence of prior myocardial infarction * more than mild valvular heart disease * prior cardiac surgery * poor technical quality of echocardiogram

Keywords: echocardiography- exercise echocardiography- dobutamine wall stress ventricular volume-left ischemia angina heart diseases stress echocardiography ventricular volume vascular diseases
localization of nonpalpable breast lesions

Conditions: Breast Cancer; Carcinoma in Situ

Summary: each year the danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. the majority of these patients are suitable for breast conserving surgery (bcs). the object of bcs is to remove the suspicious lesion completely without removing excess healthy breast tissue. to obtain this accurate lesion localization is essential. until today the standard procedure in denmark has been wire guided localization (wgl). although the method has been utilized for a number of years it has several disadvantages. often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. it can postpone the additional systemic treatment, offered after the operation. other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. the wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure. the purpose of this study is to test a new method named radioactive seed localization (rsl). the method uses a small titanium seed containing radioactive iodine. it will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. the seed can be placed a few days in advance, which means a more flexible course of treatment. the method seems promising with regards to reoperation rates, but it needs further testing. hypothesis: rsl is a more accurate method, for localization of nonpalpable breast lesions, than wgl. using rsl obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations. the study will be performed as a randomised clinical trial, where the two methods will be compared to each other. the trial will be performed at the department of breast surgery at rigshospitalet and include patients with nonpalpable breast lesions. besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.


Eligibility criteria:
inclusion criteria: * patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary. * all age groups, minimum 18 years exclusion criteria: * patients with benign nonpalpable breast lesions. * patients who are unable to comprehend the information. * patients who are pregnant, breastfeeding or have children \< 3 years. * patients who have lesions, which requires more than two wires or seeds for localization.

Keywords: nonpalpable breast lesions breast cancer and carcinoma in situ radioactive seed localization wire-guided localization randomized study
statins in cerebral blood flow and neuronal activity--a pilot study

Conditions: Alzheimer's Disease

Summary: specific aim: demonstrate that statins have an effect on cerebral blood flow and neuronal activity

a number of recent of recent studies suggests that statins, typically used to lower blood cholesterol have an effect on the brain. patients treated with statins may have increased blood flow in the brain resulting in increased activity of the brain's neurons. the neuronal system is linked to memory. brain magnetic resonance imaging (mri) with magnetic resonance spectroscopy (mrs) and magnetic resonance perfusion (mrp) will be used to assess changes in neuronal activity in patients receiving statins vs. patients not receiving statins. this is a single-site non-randomized pilot study. the study will include twenty (20), healthy consenting patients between the ages of 45 and 65 who are candidates for statin therapy as determined by their cardiologist(s). two imaging visits will be required, one magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion at baseline and one magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion three months later as described. patients will have selected their course of clinical treatment prior to recruitment. ten patients will have elected to start statin therapy with lipitor and ten patients will have elected to initially lower their cholesterol levels with diet, independent of their participation in the study. participants on the "statin arm" will receive a dose of 20 mg per day of lipitor and will receive a baseline brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion prior to receiving lipitor and follow-up brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion three months after beginning lipitor. participants on the "diet arm" will receive a baseline brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion at the beginning of the study and follow-up brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion three months later.

Eligibility criteria:
inclusion criteria: 1. otherwise healthy adults, male or female 2. age 45-65, 3. prior to treatment with any statin at a moderate or high dose - exclusion criteria: 1. previous cerebral vascular accident, 2. traumatic brain injury, 3. subarachnoid hemorrhage, 4. vascular dementia, 5. alzheimer's disease a 6. any other known vascular pathologies of the brain. 7. patients taking and/or receiving other known cerebrovascular enhancing medication/herbs and/or treatment (examples: tpa, gingko, triple h therapy, stenting procedures, etc.) 8. previous neurosurgery or intracranial procedures. 9. contraindication to mri (pacemaker, neurostimulator, other surgical implants or metals which would contraindicate mri).

Keywords: alzheimer's, magnetic resonance imaging
rhythmic reading training: comparing the rhythmic and visual contributions to reading improvement

Conditions: Developmental Dyslexia

Summary: the main objective of the study is to evaluate the specific effect of the sub-components of the reading training program rhythmic reading training (rrt) on reading speed and accuracy in a sample of italian students with developmental dyslexia (dd). more precisely, in order to better understand the neuropsychological mechanisms involved in reading improvements following rrt, the specific contribution of the visual component of the training (presence of a visual cue) will be investigated in a study with between-groups design.


Eligibility criteria:
inclusion criteria: * having been diagnosed with dd (icd-10 code: f81.0) on the basis of standard inclusion and exclusion criteria (icd-10: world health organization, 1992) and of the diagnosis procedure followed in the italian practice exclusion criteria: * presence of comorbidity with other neuropsychiatric or psychopathological conditions * having been involved in previous reading intervention programs in the previous 3 months
avascular bone necrosis in sickle cell disease: a pediatric study.

Conditions: Sickle Cell Disease

Summary: avascular necrosis (avn) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (voc). the prevalence of avn is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. in addition, bone infarcts may be the trigger for additional voc. in this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children. this is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in italy


Eligibility criteria:
inclusion criteria: * female or male patients diagnosed with sickle cell anemia (hbss, hbs/β0, hbs/β+, hbsc) with or without known avascular lesions * age ≥ 7 and \< 18 years at the moment of signed consent * written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian exclusion criteria: * - any contraindication to perform nuclear magnetic resonance magnetic resonance imaging (mri) * inability to obtain informed consent/assent

Keywords: avascular necrosis
ameliorating effects and mechanisms of tavns on constipation in pd patients.

Conditions: Parkinson Disease, Idiopathic; Constipation

Summary: the investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (hram), to investigate the improvement effect of tavns on constipation symptoms in pd patients.

the investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (hram), to investigate the improvement effect of tavns on constipation symptoms in pd patients. meanwhile, the investigators aimed to verify mechanistic effects by investigating changes in proteins and cytokines related to inflammation and intestinal barrier function in serum and feces to verify mechanistic effects.

Eligibility criteria:
inclusion criteria: 1. aged 40-70 years; 2. had a pd diagnosis designated by movement disorder neurologists (ke-zhong zhang and yong-sheng yuan) according to movement disorder society clinical diagnostic criteria; 3. fulfilled rome iv criteria for functional constipation, including having \< 3 spontaneous bowel movements (sbm; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months; 4. stable initiation of pd medications, leastways 3 month before this investigation; (5) provided written informed consent. exclusion criteria: 1. a history of previous abdominal surgery (other than appendectomy); 2. the presence of carcinoma; 3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury; 4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors; 5. a serious concomitant disease of the heart, liver, kidney, or diabetes; 6. pregnancy or lactation; 7. participating in another trial or enrolled in a trial during the past month; 8. an allergic reaction to surface electrodes.

Keywords: constipation parkinson&#39;s disease
dose-dependent effects of anthocyanins on endothelial function in healthy men

Conditions: Healthy Men

Summary: anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. the present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.

anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. a double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. on 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. flow-mediated dilation (fmd) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. blood samples will also be taken and quantification of plasma anthocyanin metabolites using uplc-q-tof-ms will be performed. the aim is to investigate whether purified anthocyanins are able to increase fmd at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.

Eligibility criteria:
inclusion criteria: * healthy men aged 18-45 years old * subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study * able to give signed written informed consent * signed written infomred consent form * healthy male subjects (no clinical signs or symptoms of cvd. exclusion criteria: * cardiovascular disease, acute inflammation, cardiac arrhythmia, renal failure, heart failure (nyha ii-iv), diabetes mellitus, c-reactive protein \> 0.5 mg/dl, malignant disease, hypotension (≤100 / 60 mm hg)
virtual reality training for inhibitory control in neurocognitive disorders

Conditions: Cognitive Disorder

Summary: executive function disorders, such as inhibitory control (ic) difficulties, are very common in older adults with neurocognitive disorders (ncd). management of these disorders is possible using traditional tools and tools based on new technologies, such as serious games and virtual reality (vr). however, today, few immersive tools exist that are specifically focused on ic training. the present study aims to evaluate the acceptability of an immersive application focused on ic in 48 patients with neurocognitive disorders. participants that will test either an immersive (vr-headset) or a non-immersive (tablet) version of the application for 4 weeks, twice a week, and fill-in acceptability related questionnaires before, during and after the end of the intervention.


Eligibility criteria:
inclusion criteria: 1. consulting the nice hospital memory center 2. diagnosis of mild neurocognitve disorder or slight major neurocognitive disorder (dsm v) 3. 60 years old or more 4. presence of deficits in inhibitory control as assessed by the frontal assessment battery 5. fluent in french 6. able to understand the informed consent form and voluntarily consents to participate exclusion criteria: 1. presence of significant vision or motor problems which would impact ability to perform the task 2. significant self-reported motion sickness 3. vulnerable persons as defined in articles l1121-5 to 8 of the french public health code

Keywords: inhibitory control serious game virtual reality cognitive disorder