Kornimate/medical-research-clean huggingface dataset:
observational study to evaluate the effectiveness and safety of the dexcom g4 continuous glucose monitoring system in pediatrics

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effectiveness and safety of the dexcom g4 system when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.

performance of the system will be primarily evaluated by comparing the blood glucose measurements from the reference device, a blood glucose meter, to the cgm system values collected during the study. specifically, performance will be primarily evaluated in terms of the proportion of g4 system values that are within ±20% of glucose meter reference value for glucose levels \>80 mg/dl and ±20 mg/dl of glucose meter reference values \<80 mg/dl. these g4-meter matched pairs will be analyzed across the 7 days of wear. safety data of the cgm system will also be collected and safety will be characterized by the incidence of anticipated device-related adverse events (ades) of subjects who participate in the study.

Eligibility criteria:
inclusion criteria: * ages 2 to 17 years; * diagnosis of diabetes mellitus; * treatment of diabetes with insulin and/or oral diabetes medication note: insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site; * willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion; * able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and * subject or guardian is able to speak, read, and write english. exclusion criteria: * extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; * known allergy to medical-grade adhesives; * for subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion; * hematocrit value outside the range of the blood glucose monitoring system used in the study; * current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study); * planned mri scan, ct scan, or diathermy during the week of the study; or * any condition that, in the opinion of the investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c, or hiv).

Keywords: diabetes mellitus pediatric continuous glucose monitoring system cgm
intervention, dietary, diabetes, pregnancy

Conditions: Dietary Habits; Obesity; Gestational Diabetes; Gestational Weight Gain

Summary: the aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index bmi≥25) and obese (bmi≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.

pregnant women are recruited for the study from 18 maternity care clinics in northern savo and northern karelia area. the participants will be randomized into intervention and control groups. all the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, three factor eating questionnaire (tfeq r-18) and binge eating scale (bes)). in addition, intervention group will get two virtual dietary counseling sessions by a dietician. the information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.

Eligibility criteria:
inclusion criteria: * bmi 25 or higher * healthy, no chronic medical conditions that can prevent participating to the study * singleton pregnancy * first trimester of pregnancy at the time of recruitment exclusion criteria: * bmi less than 25 * chronic medical conditions * multiple pregnancy * pregnancy at second or third trimester at the time of recruitment
explore the effects of cortical priming on visuomotor stepping learning in persons with chronic stroke

Conditions: Stroke

Summary: this research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.


Eligibility criteria:
inclusion criteria: 1. age between 21 and 90 years 2. medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment 3. mri or ct evidence from the imaging report shown that the stroke involves the corticospinal tract 4. hemiparesis involving the lower extremity (fulg-meyer le motor test) 5. no passive range of motion limitation in bilateral hips and knees 6. limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less 7. visual acuity can be corrected by glasses or contact lens to 20/20 8. able to walk independently with/without assistant devices for 10 meters 9. able to maintain standing position without any assistance \> 30 sec (short physical performance battery) 10. evaluation of cognitive status: mini-mental status examination (mmse) score ≥ 24 exclusion criteria: 1. pregnant women 2. mri or ct evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors 3. have any metal implants, cardiac pacemakers, or history of seizures 4. ongoing orthopedic or other neuromuscular disorders that will restrict exercise training 5. any vestibular dysfunction or unstable angina 6. significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia\*

Keywords: adult chronic stroke
longitudinal evaluation and real-world evidence of nt201

Conditions: Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face

Summary: this study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxina in botulinum neurotoxin type a (bont-a) treatment naïve participants.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * planning treatment with incobotulinumtoxina. exclusion criteria: * any contraindication to treatment with incobotulinumtoxina or any other neurotoxins. * currently pregnant, breastfeeding, or intending to become pregnant during study participation. * known hypersensitivity to incobotulinumtoxina or any of its formulation ingredients. * any infection and/or inflammation at the planned injection points. * previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
impact of modifications to the rendering of the antibiogram on the prescriptions of meropenem in pseudomonas bacteremia

Conditions: Pseudomonas

Summary: modification of the rendering of the antibiogram at the strasbourg university hospital in november 2019 with the appearance of the concept of "standard dose" or "high dose" sensitivity. this modification seems to have favored an inappropriate overprescription of meropenem (the only antibiotic made "at standard dose") in pseudomonas infections sensitive to other beta-lactams. in june 2021, it was therefore decided to mask sensitivity to carbapenems by default in the rendering of pseudomonas antibiograms when the strain was sensitive to a narrower spectrum beta-lactam ("restricted" antibiogram). the aim of this study is to evaluate the impact of these changes in the antibiogram on antibiotic prescriptions.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject with a positive blood culture result for pseudomonas spp identified in the microbiology laboratory of strasbourg university hospital during the period from june 1, 2018 to november 30, 2022 * subject not opposing the reuse of their data for the purposes of this research. exclusion criteria: * subject having expressed opposition to participating in the study, * pseudomonas spp strain resistant to all first-line beta-lactams (piperacillin-tazobactam, ceftazidime, céfepime and aztreonam). * pseudomonas spp strain resistant to meropenem. * lack of information on the antibiotic treatment undertaken.

Keywords: pseudomonas meropenem microbial susceptibility testing eucast breakpoint antibiotic stewardship
the anesthetic efficacy of 3% mepivacaine plus 2% lidocaine with 1:100,000 epinephrine for lower jaw dental injections

Conditions: Pain

Summary: the inferior alveolar nerve block (shot) is the most frequently used injection technique for achieving local anesthesia (numbness) for the teeth in the lower jaw. however, this injection does not always result in successful pulpal (tooth) anesthesia (patient felt pain). no study has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of injection (shot). the investigators propose to compare an injection of mepivacaine followed by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a difference in effectiveness.

one hundred adult male and female subjects will randomly receive two sets of inferior alveolar block injections (shots) consisting of; 1.) an injection of 1.8 ml of 3% mepivacaine followed by 1.8 ml of 2% lidocaine with 1:100,000 epinephrine, and 2.) an injection of 1.8 ml of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 ml of 2% lidocaine with 1:100,000 epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover design. whether the subject receives the mepivacaine or the lidocaine for the first injection will be determined randomly. the doctor will not know whether the subject receives mepivacaine or lidocaine for the first injection. the subject will not know which anesthetics he/she receives. a pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. the data will be statistically analyzed.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 years * good health (asa classification i or ii) * able to provide informed consent exclusion criteria: * allergy to lidocaine or mepivacaine * history of significant medical problem (asa classification iii or greater) * depression * have taken cns depressants (including alcohol or any analgesic medications) within the last 48 hours * lactating or pregnant * inability to give informed consent

Keywords: mepivacaine lidocaine inferior alveolar nerve block pulpal anesthesia mepivacaine/lidocaine lidocaine/lidocaine
limited ankle dorsiflexion and effect on single limb squats in individuals with patellofemoral pain

Conditions: Patellofemoral Pain

Summary: the purpose of this graduate student research study is to investigate the relationship between limited ankle dorsiflexion and the potential effects on a single limb squat task in the patellofemoral/knee pain population.

1. participants will undergo covid screening prior to filling out consent form and phi. randomization will occur to create an experimental group and a minimal intervention group. 2. participants will complete two self-reported questionnaires on how their diagnosis affects functional activities. 3. dorsiflexion range of motion in a weight bearing position will be taken. 4. hip abductor strength on tested limb will be measure on isokinetic device. 5. the lateral step down test will be conducted for 6 trials on each participant, 3 with a heel wedge and 3 without, movement recorded, and graded using two motion capture devices. 6. the experimental group will receive two interventions to increase dorsiflexion range of motion. the minimal intervention group will read and infographic and complete 5 minutes of treadmill walking. 7. each participant will then have their dorsiflexion measured again prior to completing another 3 trials of the lateral step down test.

Eligibility criteria:
inclusion criteria: * history of active patellofemoral pain for at least 6 months * no clinic based therapeutic interventions for a 6-month period prior to testing * females aged 18-59 years' old * limited ankle dorsiflexion as noted by \<45degs using the weight bearing lunge test exclusion criteria: * history of musculoskeletal surgery or fractures on the tested leg or lumbar spine that could affect their biomechanics during the study * history of soft tissue or skeletal abnormalities in the tested limb * current knee effusion * resting pain greater than 5/10
objective flap assessment during reconstructive surgery

Conditions: Cancer

Summary: the main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. in plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. this new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. this study will test the system's basic operation and ergonomics in the operating room.

to perform a pilot study of the flare™ nir fluorescence imaging system in conjunction with indocyanine green (icg) during breast reconstructive surgery utilizing deep inferior epigastric perforator (diep) flaps. due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. we propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. specific aims: a pilot optimization study of the imaging system in combination with icg to determine optimal dose, light excitation fluence rate, and camera exposure time.

Eligibility criteria:
inclusion criteria: * women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy. * women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist. exclusion criteria: * patients with a known or suspected iodide or seafood allergy. * patients with known renal, cardiac, hepatic, or pulmonary disease. * bmi \> 30

Keywords: breast cancer breast reconstructive surgery flap assessment
phase ii trial of romiplostim with danazol in patients with eltrombopag-resistant immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: in this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia

the patients with eltrombopag-resistant immune thrombocytopenia are treated with romiplostim and danazol. the efficacy and toxicity of treatment will be evaluated.

Eligibility criteria:
inclusion criteria: * aged over 18 years * diagnosed with immune thrombocytopenia (bone marrow examination is not necessary) * failed to achieve platelet count over 50x10\^9/l with eltrombopag * ecog performance status 0,1,2 * available to obtain informed consent exclusion criteria: * hepatitis b or c carriers * hiv positive patients * diagnosed with systemic lupus erythematosus or other autoimmune disorders * unable to intake orally or absorb through gastrointestinal tract * pregnant or breast-feeding * diagnosed with uncontrolled seizure or other neuropsychiatric disorders * diagnosed with clinically significant cardiovascular events within 6 months or dyspnea on exertion evaluated to new york heart association functional classification iii or iv * diagnosed with clinically significant cerebrovascular disorders * previously diagnosed or treated with thromboembolism * current treating malignant diseases * currently accompanied by uncontrolled infection or active bleeding * with blood test results as follows; total bilirubin \> 2xunl(upper normal limit), ast/alt \> 1.5xunl, creatinine \> 1.5xunl, glomerular filtration rate \< 30ml/min/1.73m\^2 * registered to other clinical trials for treatment of immune thrombocytopenia * judged to be inappropriate for clinical trial by doctor in charge
music & memory: a pragmatic trial for nursing home residents with alzheimer's disease (metrical)_part2

Conditions: Dementia

Summary: the purpose of this trial is to test the effects of a personalized music intervention (music and memory, inc.) on agitated and aggressive behaviors for nursing home residents with dementia.

the purpose of this study is to conduct a parallel, pragmatic, cluster randomized control trial of personalized music (music and memory) for nursing home residents with moderate to severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home corporations. music and memory is a personalized music program that uses portable music players to deliver individualized music to people with dementia at times when agitated behaviors are likely. \*\*this funding mechanism sponsored two parallel trials with different implementation strategies. in this trial, music is preloaded on personalized music devices to increase nursing use of the music with residents. details of the first parallel trial conducted under this funding mechanism are registered under "r33ag057451_part1."\*\* the aims of this study are: 1. to use a train-the-trainer model to implement the intervention with ongoing monitoring of the program's adoption and acceptance by nursing home residents with dementia; 2. to estimate the impact of music and memory on agitated and aggressive behaviors; and 3. to examine factors associated with variation in providers' adherence to the implementation of music and memory.

Eligibility criteria:
inclusion criteria for nursing homes: * owned by partnering health care corporations * medicare / medicaid-certified * have at least 20 eligible residents inclusion criteria for residents in eligible nursing homes * reside in eligible nursing home for last 90 days * have a dementia diagnosis exclusion criteria for nursing homes: * recent situations that may affect implementation (for example, bad state or federal quality assurance surveys, leadership turnover, or other competing demands) * previous use of music and memory exclusion criteria for residents in eligible nursing homes: * dislikes music * completely deaf
quality of life and disease-related symptoms in individuals with systemic mastocytosis

Conditions: Mastocytosis, Systemic

Summary: systemic mastocytosis is a rare and complex disease caused by accumulation of mast cells. the skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. symptoms can vary greatly between patients. the study aims to describe the swedish cohort's self-rated quality of life and levels of disease-related symptoms.

systemic mastocytosis (sm) is a rare and complex disease caused by accumulation of mast cells leading to release of mediator substances (e.g., cytokines, prostaglandins, histamine and tryptase). the skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. symptoms vary between patients and can include e.g., allergic reactions with anaphylaxis, rashes, osteoporoses, cognitive difficulties, fatigue, depression, anxiety, nausea, vomiting, stomach pains and diarrhea. in this cross-sectional observational study, the aim is to include the swedish cohort of persons diagnosed with sm to gather a wide range of information on self-rated health-related quality of life, gastrointestinal symptoms, pain, anxiety, depression and self-care.

Eligibility criteria:
inclusion criteria: * swedish-speaking individuals aged 18 years or older and diagnosed with indolent systemic mastocytosis (ism) or advanced systemic mastocytosis (advsm), verified by a bone marrow biopsy exclusion criteria: * an assessment by the treating physician that the individual has a cognitive impairment making participation impossible * the patient has undergone an allogeneic stem cell transplant
results of flexor tendon repair of the hand in children below six years of age

Conditions: Flexor Tendon Rupture

Summary: the incidence of flexor tendon injuries in pediatric patients has remained largely undocumented, with a frequency of 3.6 per 100 000 persons per year.the pediatric literature demonstrates a higher prevalence of flexor tendon injuries in men, caused by sharp objects (glass or knife)

the diagnosis of flexor tendon injuries is more challenging in younger children than in adults . and delayed diagnosis in children is common . an innocuous appearing skin wound and a subtle functional deficit may hinder both presentation and identification of the injury.pediatric flexor tendon injuries heal rapidly and contractures are rare, as long as the joint has not been injured. but inadequate management can result in loss of hand function . data involving children rehabilitation remain unclear, with some studies showing no difference between early rehabilitation protocols and four weeks of cast immobilization . some studies claim that protocols are not necessary in children younger than six years of age, and that only immobilization is required and some studies show transition to a more aggressive early motion protocol . although the incidince of flexor tendon injury in children is not low but the reported cases below the age of six years remains low which makes reported results less trustworthy. this created the need for a better designed and larger number study to report results in this age group.

Eligibility criteria:
inclusion criteria: * acute flexor tendon injuries of the hand in both genders. all flexor zones are included. cooperative patients aged between 0-6 years. exclusion criteria: * uncooperative patients such as psychologically disturbed patients , who will not be able to follow the strict of protocol * age more than six years old . * associated fractures close to the tendon injury. * vascular injury requiring revascularization