Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of left atrial appendage occlusion

Conditions: Atrial Fibrillation

Summary: this study is to evaluate acute and long-term safety and effectiveness of left atrial appendage occlusion (laa)with the atricure laa occlusion system. this device will be applied in patients with atrial fibrillation (af), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant maze/ablation procedure.


Eligibility criteria:
inclusion criteria: 1. documented history (paroxysmal, persistent or permanent) of af \[one episode within the last 12 months of enrollment\] 2. elective maze procedure 3. suitable anatomy 4. able and willing to sign informed consent 5. age over 18 years exclusion criteria: 1. patient from intensive care unit with either: 1. intra-venous catecholamines 2. ventilator 3. cardiac index \<1.8 l/min. 2. reoperative cardiac surgery 3. systemic or inflammatory disease 4. dialysis 5. recent myocardial infarction (\< 21 days) 6. history of pericarditis 7. patient taking part in any other device or drug study 8. patient with known sensitivity or allergy to any of the device components 9. pregnancy
ceftolozane/tazobactam versus meropenem for febrile neutropenia on patients colonized with or at risk for infection with extended spectrum beta lactamase - producing pathogens

Conditions: Febrile Neutropenia

Summary: the study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (esbl) infection. the goal is: - analyze the efficacy and tolerability of ceftolozane/tazobactam (cef/taz) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of esbl infection. patients will be randomly assigned to receive cef/taz or meropenem, with assessment of clinical response, toxicity and microbiological evolution. stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on gvhd. analysis of the results will include the taxonomic classification of the organisms present. data will be analyzed to assess non-inferiority in clinical response, incidence of gvhd, antimicrobial resistance and other outcomes.


Eligibility criteria:
inclusion criteria: - individuals who present with the onset of febrile neutropenia and at the same time present colonization with an esbl-producing pathogen (identified through positive routine rectal swabs and/or positive culture of clinical specimen) or risk of infection with an esbl-producing pathogen (use of 3rd/4th gen cephalosporin or piperacillin/tazobactam for at least 48 hours in the last 30 days). exclusion criteria: * patients known to be colonized with carbapenem-resistant or cef/taz-resistant pathogens * patients with previous use of carbapenems for at least 48h in the past 30 days are also excluded due to risk of resistance to the study drugs. * growth of a pathogen resistant to either study drug in a relevant clinical specimen during the intervention phase will be followed by adjustment of therapy according to local protocol, unblinding, and exclusion from the study. * patients that have received less than 72h of either study drug will also be excluded from the final analyses.

Keywords: febrile neutropenia ceftolozane/tazobactam esbl meropenem
policy on optimal epilepsy management

Conditions: Epilepsy; Seizure Disorder

Summary: this study examines the use of an online social media platform (patientslikeme) to assist veterans with epilepsy. the hypothesis is that the online social media platform, patientslikeme, will improve selected patient-reported outcomes on perceived self-management skills for patients who engage in the website functions.


Eligibility criteria:
inclusion criteria: * us veteran * epilepsy (seizure disorder) * \>18 years exclusion criteria: -

Keywords: epilepsy seizure veteran
analysis of post-translational modifications of a critical protein implicated in amyotrophic lateral sclerosis

Conditions: ALS

Summary: the purpose of this research study is to discover and quantitate the differences in post-translational modifications found in the cu, zn superoxide dismutase (sod1) of patients with amyotrophic lateral sclerosis (als) as compared to healthy individuals. sod1 is a known genetic cause of als. with certain mutations, sod1 gains a toxic function which leads to motor neuron death.

amyotrophic lateral sclerosis (als) is a devastating neurodegenerative disease in which mutations in human cu, zn superoxide dismutase (sod1) have been identified as a cause of familial als (fals) cases.1-2 it has been shown that mutant sod1 develops a novel toxic function through experiments demonstrating that many disease mutants maintain enzymatic activity, sod1-null mice do not exhibit als symptoms, and co-expressed wild type protein does not rescue the disease-state.7-11 the majority of cases, however, are not caused directly by mutations of sod1, instead being caused by a poorly understood interplay of several genes as well as environmental factors, which is often referred to as sporadic als (sals).3 it has been found that fals and sals share similar pathology. 4-6 the hsod1 protein aggregates characteristic of fals have also been found in sals patients, furthering the evidence that hsod1 has an important role in the etiology of als in sporadic als patients.16-19 the exact mechanism of sod1-associated toxicity has not yet been elucidated though many disease mutants have been shown to destabilize the sod1 dimer. in this study we aim to compare the levels of sod1 post-tra slational modifications in als patients to levels in healthy donors and to determine if there are distinct patterns of protein glutathionylation or phosphorylation. our overall goal is to elucidate a direct mechanism of toxicity in sals as well as identify potentially critical triggers

Eligibility criteria:
inclusion criteria: * sals patients * sod1 associated fals patients * healthy control exclusion criteria: none
evaluation of safety and efficacy of tripollar device for treatment of wrinkles

Conditions: Facial Wrinkles

Summary: the tripollar is intended for non invasive treatment of facial wrinkles and rhytides. this study was designed in order to evaluate the safety and efficacy of the tripollar.

the tripollar technology is based on three or more electrodes designed to deliver rf current focused into the skin, thus generating heat in the dermal layer. selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Eligibility criteria:
inclusion criteria: * subject read, discussed and signed the consent form, * healthy female/male aged 35 65 years, * has facial wrinkles, * capable of reading, understanding and following instructions of the procedure to be applied, * able and willing to comply with the treatment and follow-up schedule. exclusion criteria: * listed in approved protocol, and icf
active video games on physical activity (main trial)

Conditions: Physical Inactivity in Children

Summary: the purpose of the study is to test the effects of different versions of active video games (avgs) on body composition, cardiometabolic risks, and cognitive functions among overweight/obese children over 6 months.

the study aims to explore the effects of narrative-enhanced avg on (1) body composition, (2) cardiometabolic risks, and (3) cognitive functioning among overweight/obese 8-12 years old children over 6 months. a total of 210 children will be recruited from tufts floating hospital, boston children's hospital, and martha eliot health center. the investigators divided the participants into three groups to evaluate the effect of using active game consoles and stories to motivate children to exercise: a third of them have standard clinical care only; a third of them have the same standard clinical care plus an xbox and active games; the remaining third of them have the same standard clinical care, an xbox and active games, plus the stories delivered to their xbox consoles. each child, accompanied by their guardian, will be asked to visit the northeastern university exercise science laboratory over the 6-month period. blood samples, body composition (using dual-energy x-ray absorptiometry, or dexa scan), and cognitive and affective evaluations of the active video games (avgs) will be collected. additionally, parents will be asked to fill out questionnaires related to their child's physical activity behaviors. children would also be required to wear two accelerometers (essentially, a "smart watch" or activity tracker) on their wrist and waist for 7 consecutive days after the three visits within the 6 months.

Eligibility criteria:
inclusion criteria: * 8-to-12-year-old * being overweight or obese (bmi% \>=85) * speak and understand english * are willing and able to complete all measures * equal numbers of both genders will be recruited * one child per household will be eligible to participate exclusion criteria: * not between 8 and 12 * not being overweight or obese * do not speak and understand english * have medical or physical problems that prevent them from playing avgs, such as epilepsy * use orthopedic devices

Keywords: active video game physical activity narrative child obesity
prevalence of premenstrual syndrome in women of reproductive age

Conditions: Premenstrual Syndrome

Summary: the menstrual cycle is a recurring process in the lives of women from puberty until menopause. this cycle can cause various discomforts, including premenstrual syndrome. described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. this definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women. the impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. therefore, few women report the existence of these disorders to healthcare professionals. as the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed. this pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.

the main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.

Eligibility criteria:
inclusion criteria: * women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal * over 18 years of age * agreeing to participate in the study exclusion criteria: * menopause * having had a hysterectomy * with primary amenorrhea * protected by law * refusing to participate in the study

Keywords: premenstrual syndrome women reproductive age prevalence
probiotics and examination-related stress in healthy medical students

Conditions: Healthy; Stress-related Problem; Anxiety

Summary: probiotics are live microorganisms exhibiting multiple properties beneficial to health. an increasing body of evidence indicates that probiotics may support healthy brain function and may relieve stress. recent research in this area has examined lactic acid bacteria in detail, but little is known about the stress-relieving effects of saccharomyces, a yeast with probiotic properties. psychological stress is a factor that allows people to successfully cope with various daily life situations. on the other hand, excessive stress may lead to bodily harm and decrease performance, e.g. academic achievements. probiotics may help manage stress, but little is known whether probiotics improve performance under stress. the aim of this trial is to examine whether the healthy medical students may demonstrate better performance in academic examinations when supplementing their diet with a yeast probiotic strain saccharomyces boulardii (cncm i-1079) or bacterial probiotic strain lactobacillus rhamnosus gg (atcc 53103). the secondary aim of the trial is to evaluate the potential effects of this supplementation on state anxiety as well as on biochemical and physiological stress markers.


Eligibility criteria:
inclusion criteria: * being a third year medical student of the faculty of medicine or faculty of military medicine, medical university of lodz exclusion criteria: * formal inability to sit the first attempt of the final examination of basic medical pharmacology * chronic diseases: neurological, psychiatric, cardiological, gastroenterological, immunological, endocrine or infectious * state of immunosuppression * history of hospitalization (\< 3 months before entrance to the study) * presence of central venous catheter * parenteral nutrition * current pregnancy or intention to become pregnant within 3 months from the entrance to the study * current lactation * allergic reaction (\< 3 months before entrance to the study) * hypersensitivity to yeast, maltodextrins, potato starch, magnesium stearate, hypromellose, gelatin, glycerol or titanium dioxide * body mass index over 30 * chronic medication use (current or \< 3 months before entrance to the study) * systemic antibacterial or antifungal medication use (current or \< 3 months before entrance to the study) * overuse of alcohol or psychoactive substances (current or \< 3 months before entrance to the study) * tobacco smoking - more than 5 cigarettes (or equivalents) a day (currently or \< 3 months before entrance to the study) * pro- or prebiotic preparations intake (\< 3 months before entrance to the study) * vegan or other atypical diet * doing professional or extreme sports

Keywords: psychobiotics probiotics examination stress
treatment of acne vulgaris using nafl in combination with isotretinoin and pricking blood therapy

Conditions: Acne Vulgaris

Summary: background isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (av) but its side effect is a major concern for asian patients. objective investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (nafl) in combination with isotretinoin and pricking blood therapy (pbt) for treatment of av. methods a retrospective analysis of 60 patients with moderate-to-severe av was performed. four groups (n=15) were evaluated: 1,565nm nafl alone, oral isotretinoin alone, double therapy (nafl + isotretinoin) and triple therapy (nafl + isotretinoin + pbt).

background isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (av) but its side effect is a major concern for asian patients. objective investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (nafl) in combination with isotretinoin and pricking blood therapy (pbt) for treatment of av. methods a retrospective analysis of 60 patients with moderate-to-severe av was performed. four groups (n=15) were evaluated: 1,565nm nafl alone, oral isotretinoin alone, double therapy (1,565 nm non-ablative fractional laser + isotretinoin) and triple therapy (1,565 nm non-ablative fractional laser+ isotretinoin + pbt).

Eligibility criteria:
inclusion criteria: * patients ranged in age from twenty to forty years old * clinically diagnosed as a facial acne patient * the patients meet the needs of the research program of this topic exclusion criteria: * pregnancy * liver or kidney functional abnormality * skin ulceration with active bacteria * fungal or viral infection or skin cancer * coagulation disorders * patients on drugs of agents * systemic diseases such as cardiovascular disease * epilepsy * diabetes * immunodeficiency disease * active psoriasis

Keywords: acne vulgaris acne scars 1,565 nm non-ablative fractional laser isotretinoin pricking blood therapy
pilot study of the glucowatch g2 biographer for the management of type 1 diabetes in children

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: devices such as the glucowatch g2 biographer (gw2b), which constantly measure blood sugar levels, may improve the treatment of type 1 diabetes mellitus in children. this study evaluated the gw2b when used by children in their homes.

the proper role of the gw2b in the management of type 1 diabetes in children has not been determined. as a prelude to a large-scale randomized clinical trial (rct) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a gw2b versus standard care, the direcnet study group conducted a pilot study to assess the feasibility of the protocol planned for the rct and to collect data on changes in hba1c, frequency of hypoglycemia, frequency of skin reactions, and quality of life after using the gw2b for three months. fifteen children and adolescents with type 1 diabetes participated in this study. each patient was provided with a personal computer for weekly downloading of the gw2b and for completion of questionnaires regarding hypoglycemia and gw2b use. participants received study telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes management. participants had a follow-up visit at week 29. the continuous glucose monitoring system was inserted at this visit to assess hypoglycemia over three days. a follow-up visit was performed at week 30 to measure hba1c and administer psychosocial questionnaires.

Eligibility criteria:
inclusion criteria * diagnosis of type 1 diabetes * duration of diabetes \> 1 year * daily insulin therapy (pump or at least 2 injections/day) * stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump) exclusion criteria * the presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol. * prior use of a gwb prescribed for home use (prior use of a gwb as part of a research study is allowable) * the presence of any of the following diseases: * asthma if treated with systemic or inhaled corticosteroids in the last 6 months * cystic fibrosis * other major illness that in the judgment of the investigator might interfere with the completion of the protocol * adequately treated thyroid disease and celiac disease do not exclude * inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian). * current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.

Keywords: diabetes mellitus, insulin-dependent type 1 diabetes continuous glucose monitoring devices electronic data collection
clinical and therapeutic evaluation of the infection by hiv/aids

Conditions: Acquired Immunodeficiency Syndrome

Summary: the aim of the post marketing study (pms) is to evaluate the efficacy and safety profile of nevirapine in the management of the hiv/aids in an open environment.


Eligibility criteria:
inclusion criteria: * diagnosis of hiv/aids, no age limits * patients could be naïve to treatment or pretreated with other antiretroviral agents exclusion criteria: * patients with known hypersensitivity to nevirapine or any other component of the product
investigation of mp pollution in the human respiratory system and its relationship to lung cancer

Conditions: Lung Cancer

Summary: this project will study and characterize microplastic (mp) burden in the lungs of patients undergoing bronchoalveolar levage (bal) in thoracic clinics at moffitt.


Eligibility criteria:
inclusion criteria: * english or spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (bal) in thoracic clinics at moffitt. exclusion criteria: * patients with a known prior history of lung cancer or that have undergone a bronchoalveolar lavage (bal) procedure at any time in the past in the involved lung targeted for bal. * patients that have had any prior lung or thoracic or surgeries or procedures (examples: removal of lung or portions of the involved lung (lobectomy, pneumonectomy, wedge resection/segmentectomy). * patients with specimens that are considered to be non-adequate as true bronchoalveolar lavage fluid (balf) (i.e., absence of alveolar macrophages) after pathologist's evaluation will be excluded from the study.

Keywords: microplastic pollution human respiratory system
prevention interventions for opioid misuse

Conditions: Opioid Use

Summary: the purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (aya; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. this study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among ayas.


Eligibility criteria:
inclusion criteria: * aged 16-30 years * seeking care in michigan medicine emergency department (ed) * ability to read/comprehend and communicate in english * medically \& cognitively able to provide consent or assent * prescription opioid use plus \>=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse \[prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)\] exclusion criteria: * presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment * current pregnancy at baseline * history of injection drug use within last 12 months * high risk for opioid use disorder * enrolled in aim 1

Keywords: opioid misuse
intravitreal bevacizumab for proliferative diabetic retinopathy

Conditions: Vitreous Hemorrhage; Proliferative Diabetic Retinopathy

Summary: to evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (pdr) with new dense vitreous hemorrhage (vh) after previous full panretinal photocoagulation (prp).

the investigators will carry out a prospective study in patients with pdr and prior complete laser treatment who presented with new dense vh. all eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. re-injection will be done in non-clearing and recurrent vh.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus * proliferative diabetic retinopathy * prior complete panretinal photocoagulation * presented with new dense vitreous hemorrhage exclusion criteria: * one-eyed patient * previous intraocular surgery * severe lens opacity precluding fundus examination * advance glaucoma * history of thromboembolic events such as myocardial infarction and cerebrovascular accident * uncontrolled systemic hypertension, systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg * known coagulation abnormalities or current use of anticoagulant medications other than aspirin * known allergies to any relevant drugs in this study * evidence of external ocular infection such as conjunctivitis and significant blepharitis.

Keywords: bevacizumab, proliferative diabetic retinopathy, vitreous hemorrhage,