Kornimate/medical-research-clean huggingface dataset:
metabolomic alterations in the vascular compartment in patients with sepsis

Conditions: Endothelial Dysfunction

Summary: this study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock

this study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients

Eligibility criteria:
inclusion criteria: * 18 year or older * sepsis or septic shock exclusion criteria: * pregnant or breastfeeding * hemoglobin ≤ 5.0 mmol/l * platelets ≤ 5.0 mia/l * consent not obtainable * do not resuscitate order

Keywords: metabolomics systems biology sepsis
aveir vr real-world evidence post-approval study

Conditions: Cardiac Pacemaker; Arrythmia; Bradycardia

Summary: the purpose of this post-approval study is to evaluate the long-term safety of the single-chamber aveir vr leadless pacemaker using real-world evidence methods.

this is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from abbott and the center for medicare services to assess aveir vr leadless pacemaker safety in a large patient population. the results from this study will data to fulfill the condition of approval requirements for the aveir vr device from fda.

Eligibility criteria:
eligibility criteria: * implanted with an aveir vr leadless pacemaker * continuous enrollment in medicare part a and part b for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period * ability to link with medicare fee-for-service data

Keywords: bradycardia sick sinus rhythm pacemaker av block vasovagal syncope
opioid analgesic reduction study (oars) - pilot

Conditions: Post Operative Pain

Summary: the purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

a double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars subjects will be randomly assigned to either the opioid or non-opioid group.

Eligibility criteria:
inclusion criteria: * adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate. * subjects who are english speaking and are able to provide consent will be considered. * subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone. exclusion criteria: subjects who self-report the following history will be excluded from participating: * individual under the age of 18 * history of gastrointestinal bleeding and/or peptic ulcer * history of renal disease (excluding kidney stones) * history of hepatic disease * history of bleeding disorder * history of respiratory depression * any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively * active or untreated asthma * history of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia * currently taking any of the following medications: * cyp3a4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression * cns depressants. * consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism * history of drug or alcohol abuse (excludes marijuana use) * family history of drug or alcohol abuse in a first degree relative * has had one or more opioid prescription filled within the past 6 months * currently pregnant or lactating patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes: * prior participation in this study * inability or refusal to provide informed consent

Keywords: opioids pain management analgesics
effect of topical application of hyaluronic acid on stability of immediate loading dental implant in posterior maxilla

Conditions: Missing Teeth

Summary: effect of topical application of hyaluronic acid on stability of immediate loading dental implant in posterior maxilla

patients were randomly divided into two groups: group i (control group): ten implants were placed in posterior maxilla and immediately loaded. group ii (study group): ten implants were coated with ha before placement in posterior maxilla and immediately loaded.

Eligibility criteria:
inclusion criteria: * highly motivated patients with good oral hygiene. * age 18 years or older. * adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height. * free from any parafunctional habits exclusion criteria: * patients suffering from any systemic or local disease that contraindicate implant placement or surgery. * pregnancy. * smokers.

Keywords: hyaluronic acid, dental implant
randomized comparative efficacy and safety study of intermittent simvastatin and fenofibrate in hemodialysis

Conditions: Fenofibrate/Simvastatin Comparison

Summary: sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. the safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-ldl), glutathione peroxidase (gsh-px) and c-reactive protein (crp) were compared before and after 16-week treatment.

this is a prospective randomized open label parallel study. the selected patients will be randomly allocated to one of two groups * group i (30 patients): patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week). * group ii (30 patients): patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week). a careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s). monitoring parameters: for efficacy, the following parameters are measured: 1. lipid profile (total cholesterol, hdl, tg and ldl from friedwald formula \[10\] {ldl-c= tc-\[hdl + tg\\5\]). (measured at baseline and every month for 4 months) 2. c-reactive protein (crp). (measured at baseline and after 4 months) 3. oxidative stress markers: oxidized ldl and human glutathione peroxidase (measured at baseline and after 4 months). for safety: (measured at baseline and every month for 4 months) 1. observe for signs \& symptoms of muscle toxicity and measure phosphocreatine kinase (cpk). 2. liver function tests: alt, ast, alp \& albumin. 3. urea \& serum creatinine. (to monitor renal function) 4. hemoglobin 5. other measurements: body mass index (bmi), blood pressure, electrolytes (sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting. statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (crp) and oxidative stress markers (oxidized ldl and glutathione peroxidase). in addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. chronic hemodialysis patients with 3 dialysis sessions per week. 3. lipid profile: 1. total cholesterol ≥ 200 mg/dl or ldl ≥ 130 mg/dl. 2. triglycerides ≥ 150 mg/dl. exclusion criteria: 1. previous intolerance to fibrates or statins. 2. use of any fibrates or statins within 6 months prior to study. 3. hypothyroidism. 4. active liver disease \[unexplained persistent increase in liver enzymes (alt \& ast \> 2x uln)\]. 5. uncontrolled hypertension. 6. history of mi or coronary bypass surgery in last 3 months. 7. muscle toxicity (phosphocreatine kinase (cpk) \> 2x uln). 8. gall bladder disease. 9. use of any immunosuppressant or steroid.

Keywords: fibrates statins hemodialysis dyslipidemia improved oxidative stress egypt
vitamin d, steroids, and asthma in african american youth

Conditions: Asthma; Allergy

Summary: asthma has become considerably more prevalent and severe in the u.s. during the last 40 years, particularly affecting youth in urban areas, yet the reasons for this are not clear. there is increasing evidence that vitamin d insufficiency contributes to more severe asthma through increased risk of respiratory infections and decreased sensitivity to glucocorticoids. indeed, low vitamin d levels are linked with the need for exogenous glucocorticoids and increased asthma severity. particularly relevant to health disparities, we showed a strong association between vitamin d insufficiency and asthma in urban african american (aa) youth. importantly, aa youth in ours and other studies had lower vitamin d levels than non-aa participants. because aa youth residing in urban washington, dc have markedly worse asthma than other racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency department utilization rates up to 5 times the national rates and nearly 10 times the healthy people 2010 target rate), we will utilize our access to this population at the extreme of asthma disparities to examine the contribution of vitamin d to disparities in the chronic control and acute severity of asthma. the overall goal of this study is to provide critical epidemiological/molecular information that will inform the interpretation of ongoing and impending randomized clinical trials of vitamin d supplementation in asthma, especially with regard to urban aa youth with asthma. we hypothesize that low serum 25-hydroxyvitamin d \[25(oh)d\] levels are associated with poor chronic asthma control, worse acute asthma severity, and glucocorticoid insensitivity. the knowledge generated by the experiments in this application will be crucial to translation of this inexpensive, easily-accessible, and thereby potentially disparity-reducing prospective therapy for asthma.


Eligibility criteria:
inclusion criteria: * between 6 and 20 years of age * physician-diagnosed asthma for 1 year or more * caretaker/independent participant willing to sign the written informed consent, assent form when appropriate exclusion criteria: * significant, chronic medical illnesses other than asthma * no access to a phone

Keywords: obesity asthma vitamin d allergy genetic childhood pediatric cohort observational prospective molecular
a phase iiib study of bms-188667 in subjects with active rheumatoid arthritis and inadequate response to methotrexate

Conditions: Active Rheumatoid Arthritis

Summary: the only trial in participants who are methotrexate-inadequate responders and have active rheumatoid arthritis, in which gadolinium-enhanced magnetic resonance imaging; bone mineral density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of abatacept on inflammation/structural damage. study will provide valuable mechanism-of-action information on how abatacept exerts its effects (including on bone) through new techniques.


Eligibility criteria:
inclusion criteria: * disease activity as defined by a disease activity score 28-c-reactive protein (crp) \>3.2 or \>6 swollen and ≥6 tender joints and crp greater than the upper limit of normal * at least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor * clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline * participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. dose of methotrexate must be stable for at least 28 days prior to the first study dose (day 1)
validation of a new questionnaire regarding pain management

Conditions: Pain

Summary: the study includes operative as well as conservative patients using a questionnaire containing items of pain quality. after having completed the questionnaire, the patient is interviewed by an assistant. by this way the new questionnaire should be validated. in addition the patient´s personal experiences are included and conservative patients can be compared to operative patients.

it is validated whether the questions are formulated comprehensively and the patient consequently is able to understand all the different interrogated aspects of the questionnaire. exemplarily the patient is asked to express his pain in an analogue scale in various situations and which type of pain they experience (for example headache). moreover, it is tested whether there is a relation between the pain and the treatment he receives, and whether the patient expressed the need for additional medication. besides, it is asked whether he already took medication before his hospitalisation. with help of the interview, which is conducted subsequent to the questionnaire, it is verified if the patient understands the aspects. some of the questions are interrogated in depth by additional questions, for example which type of pain he experiences in which situation. one important aspect is to find out whether the patient is conscious about his medication. in order to do so, schedules are used, which are based on the documented patient's history.

Eligibility criteria:
inclusion criteria: * signing the consent form * patients with acute postoperative pain * patients with acute pain with conservative treatment * patients with ≥ 18 years of age exclusion criteria: * lack of signature of the informed consent * all physical and mental impairments which don´t allow the completion of the questionnaire or answering the interview * difficulties with the german language * \<18 years of age * isolation of patient

Keywords: questionnaire quality assurance qualitative verification conservative patients interview
comparison of liagure safety in thyroidectomy with conventional thyroidectomy

Conditions: Ligature; Hemorrhage; Recurrent Laryngeal Nerve Injuries; Hypocalcemia

Summary: to compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

due to the high vascularity of the thyroid gland and the relatively tiny operative field, rigorous hemostasis is an essential requirement for successful thyroid surgery. blood vessel ligation and/or ligation are the primary means of attaining hemostasis in thyroidectomy. new technologies have been developed, including a vessel sealing device (ligasure) that seals vessels by fusing the inner layers of the vessel wall with minimal amounts of thermal dispersion burning and tissue friction, thereby minimizing the occurrence of unintentional burns. yet. it is unclear whether the heat conveyed by a ligature can harm the recurrent laryngeal nerve due to its proximity to the berry ligament. thromosis of the inferior parathyroidal gland's supplying artery during dissection may result from alternative prospective delineation of the inferior thyroidal artery using ligasure for dissection. the purpose of this study is to assess the safety and efficacy of ligasure with standard vascular ligation in open thyroid surgery.

Eligibility criteria:
inclusion criteria: patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study any age - exclusion criteria: * patient undergoing re-do surgery " completion thyroidectomy " patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
dancing against fall fractures in osteoporosis patients and healthy elderly

Conditions: Osteoporosis; Fall Injury

Summary: this study evaluates physiological measurements and their role in among falls in healthy elderly (65yr or older) or elderly suffering from osteoporosis. the study further seeks to evaluate if dancing can be used as training for preventing falls.

this study seeks to examine the relationship between strength, postural control and bone mineral density on the risk of falling among elderly (65 yr or older). the study will carried out on osteoporosis patients and healthy, matched controls. the study further seeks to examine whether a dancing intervention may improve any of these parameters, resulting in a decreased risk of falling.

Eligibility criteria:
patient groups inclusion criteria: * verified osteoporosis (t-score -2.5 to -3.5) from previous dual-energy x-ray absorptiometry scanning (dxa) * receiving medical treatment for osteoporosis exclusion criteria: * drug addiction defined as the use of cannabis, opioids or other drugs. * use of medical cannabis. * previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses * lack of ability to cooperate. * osteoporosis grade higher than moderate or severe (t-score \< -3.5) healthy elderly groups inclusion criteria: • t-score higher than -2.5 from previous dual-energy x-ray absorptiometry scanning (dxa) exclusion criteria: * drug addiction defined as the use of cannabis, opioids or other drugs. * use of medical cannabis. * previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses * lack of ability to cooperate. * osteoporosis grade higher than mild, moderate or severe (t-score \< -2.5) * receiving medical treatment for osteoporosis
a phase 2 study evaluating jcpyv-specific t cell therapy for pml

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: this is a randomized, double-blinded, phase 2 trial in patients with pml due to jcpyv. patients will receive treatment with a matched virus-specific t-cell product (ce vst01-jc) or placebo, and will then be monitored for response to therapy.

progressive multifocal leukoencephalopathy (pml) is a demyelinating disease of the central nervous system caused by jc polyomavirus (jcpyv) occurring in immunocompromised patients who face a disease that is usually progressive and often fatal (padgett 1971; tan 2010). annually, it is estimated that 4,000 people develop pml in the united states and europe combined (nord 2015). this is a randomized, double- blinded, phase 2 trial in patients with pml due to jcpyv. patients will receive treatment with a matched virus-specific t-cell product (ce vst01-jc) or placebo, and will then be monitored for response to therapy. the study is designed to evaluate whether ce-vst01-jc infusions will slow and ultimately halt neurological progression in patients with pml compared with placebo as evaluated by modified rankin score (mrs).

Eligibility criteria:
* male or female subjects aged 18 years or older, with actively progressing pml confirmed by mri and jcpyv present in csf or in brain biopsy tissue (diagnosis confirmed according to algorithm diagnostic criteria for pml developed by the american academy of neurology).

Keywords: vst virus specific t-cell cell therapy pml jc virus
a phase 3 study to evaluate the efficacy and safety of tnx-102 sl taken daily in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this is a phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of tnx-102 sl 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.


Eligibility criteria:
inclusion criteria: * the patient is male or female 18 to 65 years of age, inclusive. * the patient has a diagnosis of primary fm as defined by the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria (american college of rheumatology preliminary diagnostic criteria) exclusion criteria: * the patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.

Keywords: pain, sleep, fibromyalgia, fm
trial of propranolol in children and youth with autism spectrum disorder and predictors of response

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to find out how the brain of people with autism is affected by propranolol. propranolol is not fda approved for the treatment of autism. propranolol is fda approved for the treatment of heart conditions such as blood pressure this research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.

the specific aim of this study is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. the investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance, heart rate variability (hrv), and the pupillary light reflex (plr), and whether anxiety can predict treatment response. the hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, and that those with the greatest degree of autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest benefit from the drug.

Eligibility criteria:
inclusion criteria: * autism spectrum disorder diagnosis * intelligence quotient (iq) \>= 85 (if aged 15-24), \>= 75 (if aged 7-14) * native english speaker * parent or caregiver must older than 18 years and be a native english speaker exclusion criteria: * taking alpha 2 agonists * non-autism learning disorder * other major psychiatric disorders * other neurological disorders * major head trauma * reaction to adhesives * diabetes * reactive airway disease * thyroid disease * bradyarrhythmias * unexplained syncope * pregnancy * possible interacting drugs * underweight (\<20kg if aged 7-14 years) * factors affecting ability to have an mri (if aged 15-24 years)

Keywords: autism asd