Kornimate/medical-research-clean huggingface dataset:
pilot study of the modified atkins diet for tourette syndrome

Conditions: Tourette Syndrome

Summary: pharmacotherapy has long been considered the primary approach for tic suppression in tourette syndrome (ts). unfortunately, medications are often ineffective and frequently have significant side-effects. this is a pilot therapeutic study using a dietary approach, the modified atkins diet (mad). the goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with ts ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. the modified atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. dietary approaches using the mad/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, parkinson's disease, and depression.


Eligibility criteria:
inclusion criteria: * ages 12-65 years * tourette syndrome (vocal and motor tics for over a year) * \> 20 score on the yale global tic severity scale * ability to follow instructions and comply with the dietary changes exclusion criteria: * secondary tics * underweight (bmi \< 5%) * prior use of the atkins diet for over 2 days * high cholesterol or triglycerides * major depression or anxiety disorder * pregnancy * substance abuse

Keywords: tourette atkins ketosis tic
single ascending dose study of cm326 in healthy volunteers

Conditions: Asthma

Summary: single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of cm326 in healthy volunteers.


Eligibility criteria:
key inclusion criteria: * healthy adult male participant,18 to 65 years of age, inclusive. * body mass index (bmi) 18 to 26 kg/m2, inclusive. * history, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant. * males must abstain from sex or use highly effective methods of birth control. * having given written informed consent prior to undertaking any study-related procedure. key exclusion criteria: * positive for hiv, or hepatitis b, or c. * positive result on urine drug screen. * clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease). * with any condition that inappropriate for entry into this study.
topical metronidazole vs control in reducing periodontal pockets in a split mouth clinical trial

Conditions: Periodontal Disease; Periodontal Inflammation

Summary: the effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids.


Eligibility criteria:
inclusion criteria: * periodontal patients with all first premolars suffering from moderate periodontal pockets (\>4mm of probing depth) exclusion criteria: * no patients received antibiotics nor periodontal treatment in the previous 6 months

Keywords: periodontal pocket periodontal disease periodontal inflammation
the cx-dz-ⅱ intelligent electroacupuncture instrument for neck pain

Conditions: Acupuncture; Neck Pain

Summary: the present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial evaluating the efficacy and safety of a new intelligent electroacupuncture instrument in treating neck pain caused by cervical spondylosis.

a total of 160 eligible patients will be included in this trial and randomly assigned to experimental group and control group in a 1:1 ratio. in experimental group, selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for control group, electroacupuncture treatment will be accomplished by a pre-existing electro-acupuncture instrument. the duration of treatment will be 2 weeks. the primary outcome is the change of visual analog scale score after one course of treatment. the secondary outcomes are visual analog scale score after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse events, defect rate of instrument, and excellent rate of instrument.

Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years old. * subject is diagnosed with cs of neck type or nerve-root type by clinical and medical imaging examination. * a history of recurrent episodes of neck pain (one or more neck pain per month lasting for more than 3 months). * pain intensity is more than 3 points on a vas upon recruitment. * subject or his guardian comprehend the aims of this trial, promise not to accept other relative treatments during the trial, and sign the informed consent. exclusion criteria: * subject has acute neck trauma. * previous medical history of neck trauma treated by surgery, or neurological deficit, or congenital and developmental spinal disorders, or systemic bone diseases, or systemic joint diseases (e.g. joint slippage). * subject is diagnosed with carotid artery dissection. * subject is unable to express clearly self-feelings (e.g. subject with severe cerebrovascular accident sequelae). * subject has infection in acupuncture region. * a history of acupuncture treatment for neck pain in the previous 1 week. * use of non-steroidal antipyretic analgesics in the previous 3 days. * subject has to use central analgesics or narcotic analgesics (e.g. tramadol, morphine, dolantin) during the period of clinic trial. * use of various ointments or medicinal liquors with functions of promoting blood circulation and/or easing pain. * use of oral and intravenous medicines with functions of opening blood vessels and providing nutrition to nerve. * combinations of severe systematic diseases (e.g. a history of myocardial infarction, or severe hepatic and renal dysfunction, or acute infectious diseases, or malignant tumors, or severe mental disturbance diseases in previous 12 months). * intolerance of acupuncture and electro-acupuncture. * allergy to acupuncture. * female in pregnancy or lactation. * subject participate other clinic trials in previous 3 months. * subject is considered to be unsuited to this trial by investigators.

Keywords: electroacupuncture instrument
cmv-specific donor-derived t lymphocytes for the treatment of recalcitrant cmv infection in a patient with primary immunodeficiency

Conditions: Cytomegalovirus Viremia; Cytomegalovirus Pneumonia; T-Lymphocyte Immunodeficiency

Summary: treatment of cmv in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using cmv-specific donor-derived t lymphocytes (cmv-vst).

treatment of cmv in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using cmv-specific donor-derived t lymphocytes (cmv-vst), a cell therapy product containing a mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus. after having receipt of therapy, the patient will have clinical assessments twice a week until discharge from the inpatient unit. after discharge, assessments will be performed on a weekly basis for three months. from 3-12 months, the patient will be seen monthly and then every three months till 2 years post planned hematopoietic stem cell transplantation. after 2 years, survival status will be assessed every 6 months through year 15.

Eligibility criteria:
inclusion criteria: * profound combined immunodeficiency * cytomegalovirus (cmv) infection * viremia * pneumonia exclusion criteria: * receiving a steroid dose of ≥ 0.5 mg/kg of prednisolone equivalent * receiving antithymocyte globulin or similar anti-t-cell antibody therapy, methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating t cells, and extracorporeal * receiving checkpoint inhibitor agents (eg, nivolumab, pembrolizumab, ipilimumab) are within 3 drug half-lives of the most recent dose to cycle 1 day 1. * administration of another investigational product

Keywords: donor-derived t lymphocytes
liberal versus restrictive use of dobutamine in cardiac surgery

Conditions: Cardiac Output, Low; Coronary Disease

Summary: inotropic agents are usually administered in the postoperative period after cardiac surgery. in most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion. recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the perioperative period. however, the use of inotropic agents may be associated with adverse events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect. this study is a non-inferiority clinical randomized study aiming to compare the use of dobutamine in a liberal strategy (in all patients at the time of withdrawal of cpb) with a restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output syndrome associated with altered tissue perfusion). our primary hypothesis is that the restrictive use of dobutamine is as safe and effective as the liberal one.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery of coronary artery bypass graft (cabg) with cardiopulmonary bypass; * age equal or greater than 18 years; * written informed consent. exclusion criteria: * previous ventricular dysfunction (ejection fraction lower than 50%) * sustained supraventricular or ventricular arrhythmias; * cardiogenic shock or need for inotropes before surgery; * immediate need of ventricular assist device or intraaortic balloon after cpb; * combined procedure; * pregnancy; * participation in another study.

Keywords: cardiac surgery dobutamine
comparing bluedop vascular expert to ankle-brachial index in the identification of peripheral vascular disease

Conditions: Peripheral Arterial Disease; Diabetes Mellitus

Summary: to compare the screening capabilities of the bluedop vascular expert (bve) and ankle brachial index (abi) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.

this retrospective and prospective single-center study to compare the accuracy and screening capabilities of bve and abi with that of conventional full leg arterial duplex (flad) was performed at a private clinic in sioux falls, south dakota, usa, with data collected from march 2023 to march 2024. currently, bve carries the european ce mark but does not yet have fda approval for use in the united states. this study was undertaken with local irb approval. patients 18 years or older who presented to the center were consented to have bve, abi, and flad performed. bve examination of lower extremity arteries were performed following the instruction for use (ifu). all examinations were performed by the same two registered vascular technologists. flad ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.

Eligibility criteria:
inclusion criteria: * patients 18 years or older who presented to the center were consented to have bve, abi, and flad performed. exclusion criteria: * patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to doppler ultrasound.

Keywords: peripheral arterial disease ankle brachial index arterial duplex doppler waveform
glucontrol study: comparing the effects of two glucose control regimens by insulin in intensive care unit patients

Conditions: Critical Illness

Summary: glucontrol is a prospective, randomized, controlled, multi-centric study. the present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively). this project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients). secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the intensive care unit (icu) and in the hospital, length of icu stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.

hyperglycemia frequently occurs during critical illness and is commonly implicated in the development of potentially lethal infectious, vascular and metabolic complications. we hypothesize that a control of glycemia by insulin will improve the vital outcome and the rate of complications in a heterogeneous population of critically ill patients. this hypothesis is supported by the findings of a recent trial performed in one surgical intensive care unit, which demonstrated a significant improvement in vital outcome and in several indices of morbidity in patients randomized to a tight control of glycemia. however, these findings can hardly be extrapolated to other conditions, including different types of pathologies and management. the present prospective, randomized, controlled and multicentric study, will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively) and will be powered to detect a 4% decrease in absolute intensive care unit (icu) mortality. secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in icu and in the hospital, length of icu stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, number of red-cell transfusions.

Eligibility criteria:
inclusion criteria: * all adult (older than 18 years old at admission) patients admitted in intensive care unit whatever the reason exclusion criteria: * absence of the informed consent (as approved by the local ethical committee). * life expectancy lower than 24 hours, as estimated upon admission. * therapeutic limitation upon admission in icu * pregnancy

Keywords: glucose glucose control insulin insulin therapy critically ill intensive care
evaluating 18f-fdg pet/ct with liver suvmax-based criteria for prognosis of patients with diffuse large b-cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: the purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver suvmax as reference can better interpret 18f-fdg pet/ct and predict disease progression during chemotherapy or survival in dlbcl.

in this study investigators develope a semi-quantitative interpretation using the liver suvmax as reference to interpret 18f-fdg pet/ct. positive lesions in pet were indicated as suvmax of residues higher than the threshold (1.6 fold of liver suvmax) or new 18f-fdg avid lesions. investigators compare the prognostic accuracy of the liver suvmax-based criteria with the 5-ps criteria and δsuvmax interpretation with respect to predicting disease progression during chemotherapy or survival in dlbcl. furthermore,investigators improve the prognostic ability of interim pet/ct by comparing the results to the clinical prognostic factors.

Eligibility criteria:
inclusion criteria: * newly diagnosed dlbcl * treated using an anthracycline-containing regimen with or without rituximab * minimal follow-up at 6 months after the completion of first-line treatment * complete medical history and clinicopathological data exclusion criteria: * secondary malignant disease * serious infection or inflammation (e.g., hiv) * primary central nervous system lymphoma * hepatic or renal dysfunction.

Keywords: positron-emission tomography prognosis
a study to evaluate the efficacy and safety of pf-06700841 in subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a 52 week phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.


Eligibility criteria:
inclusion criteria: * active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints. * active plaque psoriasis at screening and baseline. exclusion criteria: * non-plaque forms of psoriasis (with exception of nail psoriasis). * history of autoimmune rheumatic disease other than psa; also prior history of or current, rheumatic inflammatory disease other than psa.

Keywords: spondyloarthritis
transcutaneous auricular vagus nerve stimulation for treating post-stroke dysphagia

Conditions: Dysphagia Following Cerebrovascular Accident

Summary: the aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-vns) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition. 30 patients will be randomized into one of the two arms of the study: * real: real t-vns + speech therapy * sham: t-vns placebo + speech therapy. the experimental treatment consists in the association between t-vns (real or placebo) and speech therapy exercises to improve swallowing functionality. each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-vns on left ear. swallowing function and clinical conditions will be evaluated before the intervention (baseline, t0), immediately after the intervention (t1) and 3 months after the intervention (t2).


Eligibility criteria:
inclusion criteria: * acute ischemic or hemorrhagic stroke (within 7 days of onset) * dysphagia diagnosed by fees with a fiberoptic endoscopic dysphagia severity scale (fedss) score between 3 and 5 exclusion criteria: * pre-existing stroke dysphagia * dementia or other medical conditions that may interfere with the study

Keywords: vagus nerve stimulation dysphagia stroke
study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: to evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (iv) and vortioxetine 10 mg/day oral dose regimen versus placebo iv and vortioxetine 10 mg/day oral dose regimen on depressive symptoms


Eligibility criteria:
inclusion criteria: * the patient has recurrent major depressive disorder (mdd), diagnosed according to diagnostic and statistical manual for mental disorders, 5th edition (dsm-5™), classification code (296.3x). the recurrent major depressive episode (mde) should be confirmed using the mini-international neuropsychiatric interview (mini). * the patient has a montgomery åsberg depression rating scale (madrs) total score ≥30 at both screening and baseline visits. * the patient has had the current mde for ≥3 months exclusion criteria: * the patient has any current psychiatric disorder or axis i disorder (dsm-5™ criteria), other than mdd, as assessed using the mini international neuropsychiatric interview (mini). * the patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (dsm-5™ criteria). * the patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (dsm-5™ criteria). * the patient has a history of lack of response to previous treatment with vortioxetine (including current episode). other protocol defined inclusion and exclusion criteria may apply
myocardial contrast echocardiography for the assessment of the infarct related artery & risk area in patients w/ nstemi.

Conditions: STEMI

Summary: the goal of this study will be to assess the incremental benefit of myocardial contrast echocardiography for the assessment of regional wall motion abnormalities and infarct-related artery in patients presenting with their first nstemi.

patients presenting with nstemi who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary pci will be selected for participation in the study. the patients will undergo a clinically indicated resting non-contrast echocardiogram to assess lv function and regional wall motion. they will then undergo contrast echocardiography with bolus injection of optison™ contrast to reassess lv ejection fraction, improve lv opacification and assess regional wall motion abnormalities. finally, they will be given a continuous infusion of optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool. two expert echocardiographers will be asked to review in a blinded fashion the non-contrast echocardiogram, interpret the ejection fraction, and assess regional wall motion abnormalities in each of the 17 myocardial segments. they will then be asked to predict the infarct-related artery (either lad, lcx, or rca). a proposed sample size of 100 patients presenting to cedars-sinai medical center with their first nstemi will be studied. based on hospital volume, approximately 4-5 nstemi patients present to cedars-sinai on a weekly basis, of which at least 2 will be eligible per week. based on this trend, we feel we can achieve the necessary sample size within 12 months. inclusion criteria will be patients aged 31-90 presenting with world health organization diagnosis of non-st segment elevation myocardial infarction, which encompass 2 out of the following 3 criteria: a clinical history of chest pain unrelieved by nitroglycerin, ecg evidence of cardiac ischemia (st segment depression or t wave inversion), and enzymatic evidence of myocardial infarction (elevation of tni or ckmb). patients should be clinically eligible for coronary angiography.

Eligibility criteria:
inclusion criteria: patients presenting with nstemi who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary pci exclusion criteria: inability to undergo a contrast echocardiogram unwillingness to consent to a contrast echocardiogram

Keywords: echocardiogram regional wall motion abnormalities myocardial contrast