Kornimate/medical-research-clean huggingface dataset:
impact of beta-blockers on physical function in hfpef

Conditions: Heart Failure; Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Cardiac Failure; Heart Disease

Summary: the purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. we will achieve this objective by conducting n-of-1 trials. n-of-1 trials are personalized experiments that test different treatment options in an individual patient.


Eligibility criteria:
inclusion criteria: * ambulatory adults ≥65 years of age with heart failure with preserved ejection fraction (hfpef) according to acc/aha guidelines: (signs and symptoms of heart failure \[hf\] and ejection fraction \[ef\] ≥50%) * taking beta blocker exclusion criteria: * alternate causes of hfpef syndrome: 1. severe valvular disease 2. constrictive pericarditis 3. high output heart failure 4. infiltrative cardiomyopathy * other compelling indication for beta blocker 1. prior ef \< 50% 2. hypertrophic cardiomyopathy 3. angina symptoms 4. acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year 5. history of ventricular tachycardia 6. atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year 7. sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmhg * clinical instability (n-of-1 trials are appropriate for stable conditions only) 1. decompensated hf 2. hospitalized in past 30 days 3. medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at pi discretion * estimated life expectancy \<6 months * moderate-severe dementia or psychiatric disorder precluding informed consent * any condition that, in principal investigator's opinion, makes the patient unsuitable for study participation
preventing behavior and health problems in foster teens

Conditions: Parent Management Training

Summary: the primary goal of this study is to test the efficacy of two levels of the keep intervention with adolescents and their foster and kin parents in the san diego child welfare system.

the cost of child welfare services in the u.s. has been estimated at $20 billion per year. during the past decade, the number of teenagers in foster care has nearly doubled. numerous studies have documented that these adolescents are at high-risk for developing serious problems, including substance use, participation in health-risking sexual behaviors, involvement in the juvenile justice system, serious educational problems and school drop-out, failed placements/foster care "drift" and homelessness. yet, there is little research on the characteristics of interventions that can be used to guide the improvement of services for this vulnerable population of youngsters. the proposed study extends our previous research with adolescents referred for serious behavioral and emotional problems and research with elementary-aged children in foster care to a test of the efficacy of a preventive intervention for adolescents placed with foster and kin care providers in the san diego county child welfare system. two hundred and forty adolescents and their foster/kin care providers will participate (i.e., 60 in a foster/kin parent training only condition, 60 in a parent training plus youth skill training condition, and 120 in a casework "as usual" control condition). in addition to testing the efficacy of the two levels of intervention, the investigators propose to examine the effects of the intervention on a set of youth behavioral and health-related outcomes. parenting mediators to be tested include positive parenting, parental supervision, and non-harsh discipline. youth mediators are social competence, commitment to school, and knowledge about norms related to health-risking behaviors including substance use and high-risk sexual behavior. in addition, theoretical hypotheses about the effects of early risk/adversity factors to youth outcomes will be examined, and an economic analysis will be conducted to examine the relative benefits and costs associated with the two levels of intervention.

Eligibility criteria:
inclusion criteria: * any child between ages 12 and 16 years in relative or non-relative foster care exclusion criteria: * only medically fragile children

Keywords: behavior problems foster care parent training youth skills training
treating insomnia in mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI); Insomnia

Summary: the goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. the treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.


Eligibility criteria:
inclusion criteria: * aged 65 years or older * speak and read english * clinical diagnosis of mci * reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months * have access to an internet-enabled computer or tablet at home, or ability to connect a bidmc-provided tablet to the internet, with private space to complete cognitive testing * capable of and willing to provide written informed consent exclusion criteria: * evidence of significant cognitive impairment or dementia * contraindications for tms or mri * current psychological treatment for insomnia * uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., restless leg syndrome, periodic limb movement disorder, parasomnia). * diagnosis of parkinson's disease, huntington's disease, lewy-body disease, or other neurological condition known to impact sleep * current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted) * current opiate/opioid use * alcohol or drug abuse within the past year * irregular sleep schedule (bedtime before 8pm/after 2am or wake time before 4am/after 10am), unless participant states they are willing and able to change if prompted.

Keywords: transcranial magnetic stimulation neuromodulation cognitive behavioral therapy cbt-i tms sleep
a study on the prophylactic use of antibiotics within 72 hours after acute burn injury in patients

Conditions: Burn Infection

Summary: the goal of this clinical trial is to compare in acute burn patients. the main question it aims to answer are: • what is the impact of early prophylactic use of antibiotics on prognosis participants will be randomly divided into an antibiotic group and a non antibiotic group. researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * promise to comply with research procedures and cooperate with the implementation of full process research * age 18 and above * emergency hospitalization of patients in the burn department, within 24 hours after injury * no immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission * if a woman is in the reproductive period, she should not be pregnant exclusion criteria: * unable to obtain informed consent from subjects, family members, or authorized agents * at the time of admission, antibiotics were being administered * during pregnancy * presence of infectious diseases before admission * existence of immunodeficiency diseases or use of immunosuppressive drugs * the subjects are currently undergoing other clinical studies

Keywords: burn infection antibiotic
treatment of dysphagia using the mendelsohn maneuver

Conditions: Stroke; Dysphagia

Summary: the primary goal of the investigation is to determine the effects of the mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.

the primary goal of the investigation is to determine the effects of the mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (ues) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. after the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final videofluoroscopic swallow study (vfss) evaluation after 2 weeks. this means that individuals in group 1 will be re-analyzed after 1 month of additional no-treatment, and group 2 will be re-analyzed after 2 additional weeks of no-treatment.

Eligibility criteria:
inclusion criteria: * stroke (1-18 months post) * pharyngeal dysphagia exclusion criteria: * other neurologic or structural abnormality to oropharynx * history of dysphagia prior to latest stroke

Keywords: deglutition disorders mendelsohn maneuver semg
establishing a database of people with sickle cell disease (comprehensive sickle cell centers collaborative data project [c-data])

Conditions: Anemia, Sickle Cell

Summary: sickle cell disease (scd), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. the purpose of this study is to gather medical information from children and adults with scd and establish a database so that researchers can contact people to participate in future scd research studies.

scd is an inherited blood disorder. symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." the comprehensive sickle cell centers (cscc) is a network of 10 centers that conduct research to improve health care and treatment options for people with scd. this study, the collaborative data project (c-data), will establish a comprehensive database of children and adults receiving medical care at participating cscc research centers who are potentially eligible for inclusion in scd clinical trials. the main purposes of this study are the following: 1) to gather medical information about a large number of people with scd over a long period of time; 2) to identify potential participants for future scd clinical trials; 3) to collect information about how scd affects quality of life; and 4) to evaluate the relationship between scd patients' characteristics and medical events. in this study, research staff will review participants' medical records twice a year for at least 5 years. information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. once a year, participants will take part in a short interview about their health and lifestyle. participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. during an interview, participants will be asked general questions about their experience with scd and more specific questions on headaches and any possible relation they may have to scd pain. participants may also be asked to provide a blood sample at some point during the study. cscc researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in scd clinical trials.

Eligibility criteria:
inclusion criteria: * diagnosis of scd * evaluated within the 24 months prior to study entry in the hospital or clinical setting * expected to return episodically or regularly for care at one of the csccs exclusion criteria: * deceased cscc patient * inactive cscc patient

Keywords: sickle cell disease sickle cell anemia
the effect of the massage on cramp frequency, cramp severity, and sleep quality

Conditions: Muscular Cramps; Hemodialysis

Summary: the aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.

the study was conducted with patients receiving treatment in a total of four hemodialysis units. the sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. in the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. no intervention other than routine care was applied to the control group patients. in the study, the data were collected using a patient information form, cramp assessment short survey, the "visual analog scale (vas)", "pittsburgh sleep quality index" (puki̇), and patient follow-up forms. in order to conduct the study, the necessary ethics committee approval and institutional permission were obtained. the individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed. after the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.

Eligibility criteria:
inclusion criteria: * 18 years, * one or more lower work cramp attacks during/after dialysis * have a constant dryness in the last 1 month (few changes weighing more than 2 kg) * receiving at least 6 hemodialysis treatments * receiving hemodialysis treatment 3 times a week * those who have not received sub-massage therapy before exclusion criteria: * having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease * presence of any soft tissue, nerve and vascular disease in the lower extremities * presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities * having had a lower extremity operation in the past six weeks * receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability) * having a fluctuating dry weight (excluded from the study as it may cause cramping) * having been diagnosed with neuropathy in the lower extremities

Keywords: hemodialysis massage muscle cramps sleep quality
evaluation of the lithovue elite ureteroscope with intra-renal pressure monitoring technology: examination of surgeon behavior and post-operative outcomes

Conditions: Kidney Stone; Nephrolithiasis

Summary: the goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope lithovue elite.

despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. the new lithovue elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. the study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

Eligibility criteria:
inclusion criteria: * males or females over 18 years of age * undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney * total stone burden over 2 cm exclusion criteria: 1. undergoing bilateral stone treatment during the same procedure 2. patients with known genitourinary anatomical abnormalities 3. uncorrected coagulopathy 4. patients with urinary diversions 5. chronic external urinary catheters 6. women who are pregnant 7. immunosuppressed patients

Keywords: intrarenal pressure lithovue elite
evaluation of a therapeutic strategy including nebulised liposomal amphotericin b (ambisome®) in maintenance treatment of allergic bronchopulmonary aspergillosis (cystic fibrosis excluded).

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: compare the incidence of severe clinical exacerbations in the treatment of abpa, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.


Eligibility criteria:
inclusion criteria: all patients with abpa justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria: 1. atopic subject or a history of asthma , history of total immunoglobin e (ige)\> 417 ku / l (or \> 210 ku / l with a clear worsening) of a known abpa), specific immunoglobin e against aspergillus fumigatus positive ( \>0.35 kua/l) or positive skin tests. 2. associated with two other of the following criteria: documentation of precipitating antibodies or immunoglobulin g positive to aspergillus fumigatus, of radiological infiltrates associated with abpa (transitional / persistent / bronchial dilation), of blood eosinophilia \> 500 elements/mm3. 3. after informing and obtaining consent signed. exclusion criteria: * women of childbearing age who do not have an effective contraception for at least 12 first months of the study( 10 months + 2 months of treatment washout) pregnant or lactating women, * patient with cystic fibrosis * patient with a contra-indication to itraconazole * intolerance to β2 -agonists * known hypersensitivity to liposomal amphotericin b or any other component * laboratory abnormalities: significant abnormalities of platelet blood count , liver function tests (sgpt, sgot(serum glutamate oxaloacetate transaminase) , total bilirubin \> 5 times the upper limit of the normal range ) * severe renal function impairment (creatinine clearance enf to 30 ml/min) * concomitant use of one or more of the following treatments: alfuzosine, alcaloïdes de l'ergot de seigle vasoconstricteur, aliskiren, astemizole, atorvastatine, avanafil, association ombitasvir and paritaprevir, bepridil, cisaprid, dabigatran, dapoxetin, domperidon, dronedaron, eplerenone, halofantrin, ivabradin, lomitapid, lurasidon, millepertuis, mizolastin, pimozid,quétiapin, quinidin, ranolazine, ritonavir, sertindole, sildénafil, simvastatin, sirolimus, sultoprid, terfenadine, ticagrelor, triazolam vardénafil (in men over than 75) * patient with anti ige- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti ige- monoclonal antibody - * ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure * simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis * respiratory infection aggravating asthma or abpa
endovenous versus liposomal iron in ckd

Conditions: Iron Deficiency Anemia; Chronic Kidney Disease

Summary: anemia is a common complication in patients with chronic kidney disease (ckd). in addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in ckd patients. most patients with ckd are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. the iron treatment is pivotal to manage anemic patients with ckd: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. there're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. a particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. the investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in ckd anemic patients not on dialysis in the presence of iron deficiency.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * signed written informed consent; * glomerular filtration rate (gfr) ≤ 60 ml/min (mdrd gfr calculated according to 4 variables); * hemoglobin ≤ 12g/dl; * ferritin ≤ 100ng/ml with transferrin saturation (tsat) ≤ 25%; * if erythropoiesis stimulating agents (esa) therapy, stable dose for at least three months; exclusion criteria: * infectious diseases; * bleeding in the preceding six months; * history of malignancy tumor in the last 3 years; * anemia case different from that resulting from ckd; * vitamin b12 and folate deficiency; * surgery of any kind in the last three months; * systemic haematological disease; * blood transfusions, therapy with intravenous or oral iron in the last three months; * severe liver disease / test positive for hepatitis c virus (hcv) and hepatitis b virus (hbv); * abuse of alcohol and drugs in the preceding six months; * immunosuppressive therapy ; * significant weight loss; * pregnancy or breast-feeding.
safety and effectiveness of poly-l-lactic acid (plla) for the improvement in appearance of cellulite

Conditions: Cellulite

Summary: this pilot study has been designed to evaluate the safety and effectiveness of plla as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.

cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. it is often identified by a dimpled or orange-peel appearance of the skin's surface. the presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae. based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the sponsor intends to investigate the safety and effectiveness of plla for the improvement in appearance of cellulite in the posterior thighs.

Eligibility criteria:
inclusion criteria: * subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs. exclusion criteria: * known/previous allergy or hypersensitivity to any of the sculptra constituents. * known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents. * previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions. * previous treatment/procedure in or near the treatment area: 1. previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time. 2. previous semi-permanent implants exemplified by calcium hydroxylapatite (caha), poly l-lactic acid (plla) in treatment area, regardless of time. 3. previous hyaluronic acid (ha) filler or collagen filler in the treatment area within 12 months. 4. previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months. 5. previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months. 6. previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.