Kornimate/medical-research-clean huggingface dataset:
use of the paradigm 722 system to improve glycemic control in adult and adolescent subjects with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine whether type 1 diabetic subjects using the paradigm 722 system, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the paradigm 715 insulin pump only.

glycemic control remains a significant challenge for both adult and adolescent type 1 diabetics. continuous glucose monitoring (cgms) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. this data is then used to make therapy change recommendations for the future. the paradigm 722 system transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. this system will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target hba1c under monitored conditions. subjects wearing the paradigm 722 system will be compared to subjects wearing the paradigm 715 insulin pump over a 6 month period to evaluate changes in glycemic control (hba1c).

Eligibility criteria:
inclusion criteria: * age 12 - 80 years * type 1 diabetes mellitus diagnosed at least 1 year ago * using insulin infusion pump for past 6 months minimum * performing minimum 4 blood glucose tests per day * agree to treat to a1c targets * read and understand english exclusion criteria: * pregnant or planning pregnancy * history of unresolved tape allergy or skin conditions

Keywords: diabetes continuous glucose monitoring glycemic control
kinetic anesthesia device study

Conditions: Local Anaesthetic Complication; Pain

Summary: patients experience discomfort from lidocaine injections. vibrating kinetic anesthesia devices (kad) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. we will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

the study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the university of pennsylvania, and from the university city area of philadelphia. participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. participants will then be randomized to receive injection with the kad first or second. the injection will be 0.5 cc of room temperature buffered lidocaine injected at constant slow speed (approximately 5 seconds) through a 30-gage needle held perpendicular to the skin by the same surgeon, with verbal cues standardized. injections will be given in accordance with the standard of practice. when the kad is used it will be used as directed: firmly pressed on the skin adjacent to the injection, with the needle aimed into the lighted area. volunteers will evaluate each injection immediately after it is complete using the visual analog scale. when both injections are completed, participants will indicate their preference of injection, complete qualitative questions, and note necessary demographic information. injection location and order of intervention (i.e. first or second) will be noted.

Eligibility criteria:
inclusion criteria: 1. adult volunteers greater than or equal to 18 years of age 2. able and willing to provide informed consent 3. able to comprehend and comply with study instructions, and able to complete necessary evaluations. exclusion criteria: 1. patients unable or unwilling to provide informed consent. 2. patients with lidocaine allergy 3. patients with known pain-related or neurological condition. 4. patients with a known cardiac condition 5. vulnerable populations

Keywords: lidocaine vibration anesthesia injection pain discomfort dermatology dermatologic surgery local device
zoledronic acid for prevention of bone loss after bariatric surgery (zabas)

Conditions: Bone Loss; Muscle Atrophy; Bariatric Surgery

Summary: in a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

in individuals with severe obesity, bariatric surgery effectively reduces body weight, improves obesity related diseases and lowers mortality. a loss of bone and muscle mass and an increase in bone fracture risk are however seen after surgery. in this study it is examined if treatment with zoledronic acid (a drug used to treat osteoporosis) can prevent the bone and muscle loss after bariatric surgery. a single infusion of zoledronic acid or placebo is given before surgery. the study is blinded and randomized for methodological reasons. bone and muscle scans, tests of muscle strength and physical performance and blood samples (for analysis of markers related to bone and muscle metabolism) are performed at inclusion and 12 and 24 months after surgery. a total of 60 adult individuals will participate. results will be important for the evidence-based care of patients undergoing bariatric surgery and zoledronic acid. study design this is a single center randomized double-blind placebo-controlled study of zoledronic acid for prevention of bone and muscle loss after bariatric surgery. routine bariatric surgery (rygb or gastric sleeve) will be performed. the end of study is 24 months after surgery. study population patients referred for bariatric surgery at the hospital south west jutland, esbjerg will be invited to participate. randomization after inclusion and baseline assessment, patients will be randomly assigned to either zoledronic acid or placebo with a 1:1 allocation. a randomization code stratifying an equal number of participants having rygb or sg into each study arm will be applied.

Eligibility criteria:
inclusion criteria: * 35 years old or older * eligible for bariatric surgery (bmi\>35 kg/m2 with obesity-related comorbidity) exclusion criteria: * pregnancy or breastfeeding. * chronic kidney disease with estimated gfr\<45 ml/min. * hypocalcemia . * hypersensitivity to bisphosphonates, mannitol, sodium citrate or water. * metabolic bone disease (osteoporosis is allowed). * prior treatment with anti-osteoporotic agents. * treatment with oral glucocorticoids * other diseases with known effects on bone metabolism
the effect of backward walking treadmill training on balance in patient with chronic stroke

Conditions: Stroke

Summary: the purpose of this research was to discuss the effect of backward walking treadmill training on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic stroke.

walking training is a good method and strategy to improve postural stability, balance, gait symmetry, and increase walking ability. generally, there are many walking training theories and methods for patients with chronic stroke and treadmill walking training is applied in recent years. previous studies showed that patients with stroke improve the walking abilities and speed after the walking treadmill training. however, most studies have demonstrated that forward walking treadmill training improved balance and walking ability in patients with stroke, but fewer studies have investigated the effects on backward walking treadmill training. however, no studies to date have investigated the effects of backward walking treadmill training for patients with chronic stroke.

Eligibility criteria:
inclusion criteria: * this experiment recruited subjects with chronic stroke more than six months, whose level of brunnstrom stage was beyond iv and who were able to walk more than eleven meters with or without assistive devices exclusion criteria:

Keywords: chronic stroke cardiopulmonary berg balance scale (bbs)
couples hiv counseling and testing for male couples in the united states

Conditions: HIV

Summary: this is a study to determine whether testing for hiv together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. testing of couples together has been provided for decades in africa, but has never been tested in the united states. in this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. at the time of testing, investigators will ask questions about how they felt about the service they received. three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. the main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). although the study is not designed to determine if the service reduces risk behaviors for hiv transmission, investigators will examine data on risks just to explore that topic. the main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.


Eligibility criteria:
inclusion criteria: * male at birth * currently self-identify as male * at least 18 years of age * have been in a couple with a man for at least 3 months * willing to complete a follow-up study visit in 3 months * able to complete study assessments in english. exclusion criteria: * known to be hiv-positive * over 39 years of age * either partner being unwilling to accept randomization to the couples testing arm * either partner planning to move from the atlanta area within 3 months of the initial study visit * either partner reporting a history of intimate partner violence * either partner reporting feeling coerced to tested with his partner

Keywords: homosexuality, male
pilot study of terazosin in treatment of antidepressant induced excessive sweating

Conditions: Antidepressant Induced Excessive Sweating

Summary: this study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be effective in reducing excessive sweating caused by antidepressant treatment, and will have minimal adverse effects.

sweating is a common and bothersome side effect of treatment with antidepressants. most or all antidepressants have been clearly shown to cause excessive sweating. it is unclear to what extent excessive sweating caused by antidepressants becomes less or goes away with time. in many instances, it continues to be a problem even after 6 or more months on the antidepressant. there is no generally accepted treatment for excessive sweating. this study has been designed to study whether terazosin is effective in reducing antidepressant-induced sweating, and whether it is well-tolerated and acceptable to patients. in addition, secondary objectives of this study are to determine the time taken for patients to respond to terazosin, the usual doses needed for improvement, and the extent of reduction in sweating. this information will not only help doctors in using terazosin for this purpose in their patients, but will help in designing further studies of this treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a depressive disorder (diagnostic and statistical manual of mental disorders - iv-tr) * presence of excessive sweating by self-report * the excessive sweating started after initiation of an antidepressant and, if treatment with the antidepressant was interrupted, did not persist for more than 4 weeks during that interruption * treatment with the antidepressant is deemed to be clinically necessary due to substantial benefit from this antidepressant, and failure to respond to or tolerate an alternative * excessive sweating has persisted for at least 4 weeks prior to baseline assessment * the excessive sweating is rated by the patient as at least moderately bothersome. * episodes of excessive sweating occur at least twice a week for last 4 weeks exclusion criteria: * presence of another known disease that could potentially cause excessive sweating * failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past * blood pressure less than 110 mm hg systolic at the screening or baseline visits * orthostatic hypotension by history or on assessment at the screening or baseline visits (defined as a decrease of 10 mm hg or greater after standing for 2 minutes). * current antihypertensive treatment * history of significant cardiac disease, including coronary artery disease * current use of phosphodiesterase type 5 inhibitors: sildenafil (viagra™), tadalafil (cialistm), or vardenafil (levitratm) * history of priapism (persistent and painful erection)

Keywords: antidepressant induced excessive sweating
a study of mg-k10 in subjects with asthma

Conditions: Asthma

Summary: this study is a phase ib/ii clinical trial conducted in chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of mg-k10 humanized monoclonal antibody injection in the treatment of asthma.

the study was conducted in two phases: the phase ib study focused on the safety and tolerability of mg-k10 in adult asthma subjects. phase ii study focused on the preliminary efficacy in adults with moderate to severe asthma.

Eligibility criteria:
inclusion criteria: * asthma diagnosed according to the 2021 version of the gina guidelines for at least 1 year; * 1 second forced expiratory volume (fev1) before randomization before bronchodilator use the measured value is ≤80% of the normal predicted value; * must have experienced at least one severe acute asthma attack within 12 months outbreak event. * positive bronchodilator test * subjects and partners agree to take effective contraceptive measures from signing the informed consent form (icf) to 6 months after the end of treatment exclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease (copd) or other lung diseases that may impair lung function * subjects with malignant tumor within 5 years * received biologics with the same therapeutic purpose within 6 months prior to screening, * women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;

Keywords: asthma
intrapartum ultrasound in labor: sonography only, few internal examinations

Conditions: Labor Complication

Summary: this is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. other secondary outcomes include maternal satisfaction and overall birth outcomes.

it is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. with this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (angle of progression, head perineum distance, midline angle, cervix dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations. primary outcome is the incidence of clinical chorioamnionitis. secondary outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.

Eligibility criteria:
inclusion criteria: * pregnant women of at least 18 years of age with a singleton in the cephalic position * spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted. exclusion criteria: * emergency situations such as maternal or fetal bleeding * indication for urgent delivery by caesarean section * pathological cardiotocogram * non-cephalic positions * under 18 years of age * women giving birth who are unable to give consent

Keywords: chorioamnionitis sonography
project incharge: increasing the rate of comprehensive eye care utilization by older african americans through community-based eye health education program

Conditions: Eye Disease; Eye Care; Vision

Summary: the study design is a randomized intervention evaluation. ten senior centers in predominately african american communities in the birmingham, alabama will be selected as sites for the educational intervention. five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older african american population. the other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. the primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. the secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.


Eligibility criteria:
inclusion criteria: * african americans ages \>=60 years residing in the communities targeted for intervention or control activities exclusion criteria: * persons who do not speak english, persons who are not community-dwelling.
placenta accreta spectrum protocol

Conditions: Placenta Accreta

Summary: aim of this project is to study diagnosis and management approaches of pas and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. we aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. to achieve these objectives, creation of an international database collected by pas-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of pas

placenta accreta spectrum (pas) is a complex placentation disorder associated with high maternal morbidity; complications of pas include hemorrhage, blood transfusion, multiple organ failure, and death * the incidence of pas has been increasing steadily in response to the increase in cesarean delivery rate * available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of pas however, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. therefore, several conservative management options were proposed as an alternative to hysterectomy * although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited * there is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. as a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of pas and appropriate patient selection for conservative management

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed with pas, aged between 18 to 48 years. * women should be delivered by the corresponding center. exclusion criteria: * inadequate follow-up * authorization to use anonymous patient data for research purposes.
a study to evaluate the safety of rituximab retreatment in subjects with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: this is a phase ii/iii open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. this study is open to participants previously enrolled in genentech study u2971g only.


Eligibility criteria:
inclusion criteria: * subjects with systemic lupus erythematosus (sle) who participated and satisfactorily completed their week 52 evaluation in study u2971g. * for partial clinical response (pcr) or nonclinical response (ncr), active disease at screening as defined by one or more domains with a british isles lupus assessment group (bilag) a score or 2 or more domains with a bilag b score. exclusion criteria: * subjects who were withdrawn from study u2971g because of protocol non-compliance or for safety issues. * any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety. * subjects who were withdrawn from study u2971g and received rituximab rescue therapy outside of the protocol. * subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by week 52 in study u2971g and in whom the proposed therapy would represent risk without benefit. * unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions. * pregnant women or nursing (breastfeeding) mothers. * history of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies. * known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening. * history of cancer, including solid tumors, hematological malignancies, and carcinoma in situ. * major surgery within 4 weeks prior to screening. * intolerance or contraindication to oral or iv corticosteroids. * positive hepatitis b surface antigen (bsag) or hepatitis c serology. * receipt of a live vaccine within 28 days prior to treatment.

Keywords: rituxan sle lupus