Kornimate/medical-research-clean huggingface dataset:
intermediate and long acting insulin young children type 1 diabetes.

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia; type1diabetes

Summary: background: achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with type 1 diabetes(t1d). optimal insulin therapy for young children with t1d should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. objectives: to compare the effectiveness of insulin degludec to insulin glargine and nph in toddlers and preschool children with t1d in terms of glycosylated hemoglobin(hba1c) and frequency of hypoglycemic episodes.


Eligibility criteria:
inclusion criteria: * toddlers and preschool children with t1d on insulin therapy exclusion criteria: * patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (mody) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening.
myofascial release in patients with plantar fasciitis

Conditions: Plantar Fasciitis

Summary: background: plantar fasciitis is the most common cause of heel pain in runners. no studies have described the short-term effects of myofascial release on plantar fasciitis using ultrasound. objectives: to describe the immediate sonoelastographic changes in the plantar fascia of amateur runners with fasciitis after applying a myofascial release technique. design: a single-centre, experimental and controlled study. method: patients with plantar fasciitis and a group of healthy subjects will be examined using b-mode and real time sonoelastography scanning. fascia thickness, echointensity and echovariation of the color histogram will be analyzed pre- and post intervention. a two-way (group × time) repeated measures anova will be performed.

participants subjects of the plantar fasciitis group (pfg) will be recruited in may2018 to apply to them a myofascial release technique. healthy volunteers without a history of plantar fascia disease will be recruited as control group (cg). the examination will be included b-mode scanning and real time sonoelastography using an us scanner with linear array transducer (ml6-15). all examinations will be conducted by a sonographer with more than 10 years' experience in musculoskeletal imaging. using a standardized protocol three images of every pre-post intervention video will be stored uncompressed and with no losses in bitmap format (bmp), and the mean value of the histogram components will be used for statistical analysis. the examination protocol shows good reliability, and has been reported previously. imagej 1.45 software will be used to perform quantitative analysis of gray-scale images and the color histogram of the elastogram.

Eligibility criteria:
inclusion criteria: * heel pain at the proximal fascia insertion * worse pain when waking up in the morning or after a period of rest * a visual analog score (vas) of more than 4 on a scale of 10 exclusion criteria: * patients who had undergone surgery or steroid injections to the heel will be excluded.

Keywords: plantar fasciitis physical therapy sonoelastography
optimal low b-value in intravoxel incoherent motion diffusion-weighted mr imaging of the brain

Conditions: Healthy Volunteers

Summary: our research aims to reveal whether the low b-values distribution and the number of nex for each b value will influence the accuracy of pseudodiffusion parameter derived from ivim in brain.

as an improved mri technique, diffusion-weighted imaging (dwi) is considered the most sensitive for early pathological changes. perfusion measurement has been shown to improve sensitivity and predictive value for tumor grading and prognosis, also as a predicator of recovery with reperfusion in patients of acute ischemic stroke.our research aims to reveal whether the low b-values distribution and the number of nex for each b value will influence the accuracy of pseudodiffusion parameter derived from ivim in brain.

Eligibility criteria:
inclusion criteria: * no hypertension or cerebral vascular diseases, * no systemic metabolic disease; * no infection or fever; * no use of corticosteroid drugs; * no mri contraindication. exclusion criteria:

Keywords: ivim brain diffusion-weighted imaging
efficacy and safety of biphasic insulin aspart 30 with metformin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa. the aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus oad compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * currently treated with maximum doses of any kind of oad alone or any kind of oral combination therapy for at least 2 months * body mass index (bmi) below 40.0 kg/m2 * hba1c between 7.5-13.0% exclusion criteria: * history of drug or alcohol dependence * mental incapacity, unwillingness or language barriers precluding adequate * subjects previously screened to participation or having already participated in this trial * receipt of any investigational drug within the last month prior to this trial * known or suspected allergy to trial products or related products
metformin improves clinical pregnancy rate in polycystic ovarian syndrome patients

Conditions: Reproductive Endocrinology; Polycystic Ovarian Syndrome

Summary: polycystic ovary syndrome (pcos) is the most common female endocrine disorder , with a prevalence ranging between 6% to10% based on the national institutes of health (nih) criteria and when the broader rotterdam criteria are applied it reaches as high as 15%. typically, pcos can identify during the early adolescence. insulin resistance is a common finding in the obese women with pcos. it is most prevalent and severe in pcos phenotype involving hyperandrogenism and chronic anovulation. women with pcos who have regular cycles are metabolically less abnormal. acanthosis nigricans (an) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. although an is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant pcos were reported in a popular randomized, double-blind, placebo-controlled trial . the first pharmacological approach to induction of ovulation in women with pcos is clomiphene citrate


Eligibility criteria:
inclusion criteria: * all patients with pcos fulfilled at least 2 out of the three criteria of rotterdam consensus 2003 exclusion criteria: * liver disease * heart or respiratory failure * alcohol abuse * kidney disease
association of lifestyle with complications in the diabetic population

Conditions: Diabetes Mellitus

Summary: this study is a prospective study of patients with diabetes. the main objective of this study is to investigate the relationship between lifestyle and long-term complications in diabetic patients, which will help to screen out the high-risk group at an early stage and provide scientific advice for the prevention of complications in diabetic patients.


Eligibility criteria:
inclusion criteria: 1. patients with a normative diagnosis of type 2 diabetes 2. age ≥20 years old, regardless of gender 3. from january 2022 to december 2025, he was treated in nanfang hospital exclusion criteria: 1. in the acute infection phase 2. the researchers judged that it was not suitable to participate in this study
gamification to increase mobility in the hospital

Conditions: Coronary Artery Disease; Coronary Heart Disease; Hypertension; Diabete Mellitus; Dyslipidemias; Obesity; Heart Failure

Summary: low mobility is a mediator for poor outcomes of hospital care. wearable devices will be used and 2-way texting via patient smartphones to monitor patients' physical activity during hospitalization with and without gamification to improve patient adherence to existing guidance on recommended activity. after discharge, investigators will assess patient care utilization (snf, inpatient vs home rehab, ed visits, readmission) and conduct validated surveys on patient function at 30 days after discharge.

hospitalization is a common occurrence for older adults; approximately 6.8 million medicare seniors experience an admission for acute care in any given year. this is often a sentinel event in the overall health trajectory of older adults that is complicated by functional impairment, skilled nursing facility placement, and reduced mobility after discharge. in the current paradigm, low mobility during hospitalization is largely viewed as a temporary inconvenience that should not affect overall functional ability or outcomes such nursing home placement and that patients should return to their previous activity level soon after they return home without lingering mobility changes. recent research, however, suggests disruptions of basic activities of daily life such as mobility (getting out of bed and walking) may be "traumatic" or "toxic" to older adults with long-term post-hospital effects. what is lacked is precise data on how much immobility is noxious and how much mobility is needed to protect against adverse outcomes. the primary objective is to assess the effectiveness of a gamification intervention to increase physical activity before hospital discharge. investigators will explore patients' physical activity while in the hospital and if that differs across floors that have already deployed a nursing mobility protocol (founders 10, 11, 12, 14). investigators will also explore changes in patient functional status, snf placement, and 30-day hospital readmission.

Eligibility criteria:
inclusion criteria: * admitted to a medicine or cardiology floor in the hospital * age 50 years or older * have an ampac (mobility scale) score of greater than or equal to 21 or a braden mobility sub-scale score of 4. exclusion criteria: * inability to provide informed consent * does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the study team can provide * inpatient ampac score of less than 21 or a braden mobility sub-scale score less than 4 indicating that independent physical activity may not be appropriate for the patient * are already enrolled in another physical activity study * any conditions that would prohibit participation in an inpatient physical activity program (at the discretion of attending physician or nurse caring for the patient in the hospital). to minimize the risk of contamination across study arms, we will only approach one patient per hospital room in shared rooms
robotic vs. freehand corrective surgery for pediatric scoliosis

Conditions: Scoliosis

Summary: to compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients


Eligibility criteria:
inclusion criteria: 1. pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater 2. patient capable of complying with study requirements 3. signed informed consent by patient exclusion criteria: 1. scheuermann's disease 2. infection or malignancy 3. primary abnormalities of bones (e.g. osteogenesis imperfecta) 4. primary muscle diseases, such as muscular dystrophy 5. neurologic diseases (e.g. charcot-marie tooth, guillain-barre syndrome, cerebral palsy, spina bifida, or neurofibroma) 6. spinal cord abnormalities with any neurologic symptoms or signs 7. spinal cord lesions requiring neurosurgical interventions, such as hydromyelia 8. patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery 9. patients requiring anterior release or instrumentation 10. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. 11. pregnancy 12. patient cannot follow study protocol, for any reason 13. patient cannot or will not sign informed consent

Keywords: adolescent idiopathic scoliosis pediatric scoliosis
efficacy and safety of urgobd001 compression system

Conditions: Venous Leg Ulcer

Summary: evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new urgo bd001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

this is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage c6 / c6r of the ceap classification. this study is carried out in around 55 french investigational centers. a total of 178 patients meeting the eligibility criteria will be included. the patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers. a planimetric survey of the studied vlu is carried out during the initial assessment of the wound (day 0) and at each assessment provided for in the protocol (week 2, week 4, week 8 and week 12).

Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years old), having given free, informed and written consent * patient affiliated to a social security scheme * patient agreeing to wear the study compression system daily * patient with an ankle circumference between 18 and 25 cm * target wound: stage c6 / c6r leg ulcer of the ceap classification with a 0.8≤ abpi≤1.3 * target wound with an area between 1 and 20 cm2 * target wound with age of ≤24 months criteria exclusion: * patient with a systemic infection not controlled by appropriate antibiotic therapy * patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis * patient with advanced stage ii or stage iii lymphoedema * patient bedridden or spending less than an hour per day standing * clinically infected target wound * cancerized target wound

Keywords: compression system vlu mixed vlu
pharmacokinetic and safety study of oms201 in subjects undergoing ureteroscopic treatment for removal of urinary tract-located stones

Conditions: Urinary Calculi; Urinary Stones; Urinary Tract Stones

Summary: evaluate the safety and systemic absorption of oms201 following exposure during ureteroscopy.

oms201 is being developed to facilitate endoscopy of the ureters and to reduce postoperative discomfort, such as pain, frequency, urgency and/or difficult urination following endoscopic surgery to remove a urinary tract stone.

Eligibility criteria:
inclusion criteria: * subject is undergoing unilateral ureteroscopic removal of renal collecting system or ureteral stones located in the ureter with a maximum stone diameter of 12 mm, for which general anesthesia will be used. * subject's physical examination is within normal limits or examination is clinically non-significant for purposes of the study as determined by the investigator, and subject is in good general health. * subject's laboratory evaluations are within normal limits or evaluations are clinically non-significant as determined by the investigator. * female subject of childbearing potential who is using an effective method of birth control within at least 14 days prior to surgery and has a negative pregnancy test. * subject is at minimal risk from anesthesia and is classified according to the american society of anesthesiologists physical status classification as either ps-1 or ps-2. * subject's body mass index is between 19 and 35, inclusive, based on the body mass index table. exclusion criteria: * subject taking a prohibited medication. * subject who has had a renal transplant, has a single kidney or has evidence of a compromised renal function as measured by abnormal serum creatinine, as judged by the investigator, or who has evidence of urinary tract infection, or has prior history of open or laparoscopic surgery, or any history of an ureteral stricture. * subject who has congenital anomalies that would engender an increased procedural safety risk such as ureteropelvic junction obstruction resulting in severely dilated renal pelvis, duplicated urinary collecting system, horseshoe kidney or vascular anomalies such as renal arteriovenous fistulas or papillary necrosis. * subject has bilateral renal or ureteral stones requiring concurrent ureteroscopic removal. * subject with clinically significant hypotension at screening. * subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory or other medical disorder as determined by the investigator. * subject on chronic diuretic use. * subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.

Keywords: urinary calculi urinary stones urinary tract stones calculi
efficacy of oral administration of trehalose in patients with parkinson disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a neurodegenerative disease characterized by the neurodegeneration of substance nigra pars compacta (snpc) and the formation of alpha-synuclein protein aggregates in neurons. although most pd patients are sporadic, it is now clear that genetic factors contribute to the pathogenesis of pd. indeed, lrrk2 g2019s mutation is one of the most common causes of familial pd. the phenotype corresponding to this mutation is a late-onset form of pd characterized by the accumulation of the n-ethylmaleimide sensitive factor (nsf) in neurons. it is due to a dysfunction of the physiological autophagy processes occurring at cellular level, mainly affecting autophagy mediated by chaperone proteins (chaperon mediated autophagy, cma), responsible for the clearance of alpha synuclein at the lysosomal level. this condition, although sensitive to treatment with l-dopa and dopamine agonists, does not currently have any specific therapy. recently, in a mouse model carrying the lrrk2 mutation, it has been demonstrated that treatment with trehalose is able to reduce the accumulation of nsf deposits in neurons of various brain areas such as the substantia nigra, striatum, cortex and hippocampus. the reduction of protein aggregates correlates with intracellular molecules related to the activation of apoptotic processes in damaged neurons. moreover, it has been found a significant improvement in motor and cognitive performance. the aim of the present study is to evaluate the safety and tolerability of trehalose in two groups of patients affected by idiopathic pd and pd carrying the lrrk2 mutation, respectively. moreover, the investigators will collect preliminary data on the effect that this molecule potentially has on disease course in both groups. the treatment duration will be 24 weeks and the overall study duration approximately 12 months. the populations observed will be composed of subjects affected by idiopathic pd and familial pd carrying the genetically confirmed lrrk2 mutation. enrolled subjects will daily take trehalose in oral administration. safety will be assessed by detecting any adverse events and analyzing blood chemistry parameters. the effect of trehalose will be evaluated through periodic clinical examinations, including the administration of specific scales and questionnaires.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent; * pd diagnosis according to uk parkinson's disease society brain bank clinical diagnostic criteria (ukpds); * age between 18 and 80 years (inclusive); * hoehn \& yahr staging \> 1; exclusion criteria: * inability to provide written informed consent; * diagnosis of other concomitant neurodegenerative disease; * concomitant treatment with drugs similar to trehalose; * hypersensitivity or intolerance to the active substance administered; * severe swallowing problems; * participation in other interventional studies within 30 days from the screening; * other medical conditions that can interfere with results or endanger the participant.
natural history of anterior compartment pressures of the thigh following femur fracture

Conditions: Femur Fracture

Summary: this study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.

compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. the purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. this small project is designed to be a non-randomized, investigational prospective trail to be conducted at the general division of charleston area medical center. the target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.

Eligibility criteria:
inclusion criteria: * femur fracture * age 18 and older exclusion criteria: * patients who are not candidates for surgical repair of femur fracture * patients not expected to survive more than 1 week

Keywords: compartment pressure compartment syndrome femur fracture