Kornimate/medical-research-clean huggingface dataset:
the effect of different sedation regimes on cognitive function in lower gastrointestinal system endoscopy

Conditions: Gastrointestinal Dysfunction; Alteration of Cognitive Function

Summary: there are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. this study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.

sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. the aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. in group mm where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (fps) was greater than 3. in group rp where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when fps was greater than 3. bispectral index (bis) and hemodynamic monitorization was carried out throughout the procedure and bis 60-80 with fps\<3 was targeted. the time to observer assessment of alertness/sedation scale (oaas) score to reach 3 was measured after the procedure and trieger dot test (tdt) and digit symbol substitution test (dsst) was repeated at 5th, 15th and 30th minutes.

Eligibility criteria:
inclusion criteria: * patients between 18-65 years of age (asa i-iii risk groups), scheduled for elective colonoscopy exclusion criteria: * patient refusal * mini mental test (mmt) score\<26 * amsterdam preoperative anxiety and information scale (apais ) score \>10 * advanced cardiopulmonary or psychiatric disease * chronic alcohol abuse * morbid obesity * known allergy to study drugs

Keywords: cognitive dysfunction colonoscopy sedation
adult mdw dual cut-off accuracy study

Conditions: Sepsis

Summary: this study will establish the clinical performance of the monocyte distribution width (mdw) parameter on the dxh 900/ dxh 690t hematology analyzers to aid in the detection and risk assessment of patients in the emergency department (ed) for progression to sepsis.

the objective of this study is to validate the mdw dual cut-off values established during characterization and demonstrate the performance of mdw to detect sepsis in a multi-center study of adults presenting to the ed who have cbc w/diff ordered within 12 hours of presentation. this study is designed to enroll all-comers from selected sites that currently have a dxh 900 in use as part of routine testing in the ed. all subjects who meet the inclusion criteria will be included in the study, without enrichment. data from all subjects meeting the inclusion criteria will be provided to a panel of independent adjudicators. adjudicators will be blinded to the mdw result and any sepsis diagnostic determinations which may or may not be in the original medical record.

Eligibility criteria:
inclusion criteria: * adults (18 to 89 years) of all races and ethnicities presenting to the ed * whole blood venous samples collected in k2edta while the patient was in the ed * first cbc w/diff test ordered within 12 hours of presentation to ed as part of their standard medical care * cbc w/diff tested within 2 hours of specimen collection * subjects with at least ≥12 hours of follow-up in the ed (or inpatient, if admitted) from presentation exclusion criteria: * cbc w/diff test ordered after 12 hours of presentation to ed * subjects previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study) * subjects discharged from ed \<12 hours from ed presentation * ed transfer patients data exclusions post enrollment: * samples that have a system generated flag from the standard of care (soc) cbc w/diff testing will be excluded. * samples with instrument flags, including vote outs and review flags for mdw will also be excluded (i.e. invalid mdw results). * subjects' data collected with instrument quality control failure(s).

Keywords: sepsis diagnosis mdw
functional evaluation of the total knee prostheses:rising from a chair

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: in this study, a functional evaluation of total knee arthroplasty (tka) patients is performed. the patients are measured prior to surgery and 6 and 12 months after surgery. the measurements consist of questionnaires and rising from a chair. also, two types of tka are functionally evaluated. at last, the tka group will be compared to a thp group.


Eligibility criteria:
inclusion criteria: * unilateral tka exclusion criteria: * tka bilateral * recent thp * movement disorders like parkinson's disease, insults, that disturb equilibrium and movements

Keywords: c05.550.114.606.500 c05.550.114.606.508
multi-sensory training and wrist fractures

Conditions: Postural Balance

Summary: the aim of the study is to investigate whether individuals with fall-related wrist fractures have impaired posterior control, reduced proprioception in their lower limbs and/or vestibular asymmetry compared with those who have not fallen and sustained a fracture. secondly to investigate the effects of a new balance training method, directed at the sensory systems and training of fall-preventive movements on postural control and how it impacts the function of the sensory systems. postural instability falls and fractures form one of the major problems associated with ageing. an association of vestibular- asymmetry with falls and fractures has been found and reduced vibration sensation in the lower limbs has been connected with imbalance. wrist fractures are often precursor to the more serious hip fractures, which often result in decreased quality of life, even death and are costly for the society. subjects will be individuals 50-75 years of age having sustained a fall-related wrist fracture. measurements of sensory functions, postural control and functional ability will be conducted before and after balance training. confidence in daily activities and self-perceived dizziness handicap will be obtained with questionnaires. the same evaluations will be performed on age and gender matched individuals without previous history of fall-related wrist fractures. this research might reveal the presence and frequency of vestibular asymmetry or/and other age related degenerative changes in the sensory systems, which decrease stability and increase the risk of falls and fractures. it could show preventive effects of specific balance training on fall risk, and thus increase quality of life of the individuals, improve healthcare services and decrease costs associated with falls and fractures.


Eligibility criteria:
inclusion criteria: * aged 50-75 years * sustained a fall-related wrist fracture * mentally and physically able to understand and undergo the study measurements and training. * able to walk 30 metres unsupported or with an aid of a stick/crutch * able to stand unsupported for ten minutes * normal corrective vision * have signed an informed consent for participation in the study exclusion criteria: confirmed diagnosis of degenerative central nervous system (cns) diseases, such as parkinson, alzheimer and other diseases impairing mobility and cognitive function and hence precluding participation in the study. more detailed exclusions criteria: * previous history of stroke * parkinson * ms * multisystem atrophy * motor neuron disease * dementia, decline of cognitive function * serious mental illness * amputation in lower limbs * epilepsy on medical treatment

Keywords: fracture rehabilitation wrist sensation exercise
evaluation of a prototype diabetes management system applied to insulin initiation and titration

Conditions: Type II Diabetes

Summary: the purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the joslin clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. hypothesis: the use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at joslin diabetes center.


Eligibility criteria:
inclusion: * 18 years or older * has type 2 diabetes, starting on basal insulin therapy * hemoglobin a1c between 9-14% * has wi-fi internet connection at home * is willing to monitor blood glucose at least once per day * is willing to inject and self-titrate insulin dose * able to read and communicate in english proficiently exclusion: * has severe visual impairment impacting visual acuity * has severe hearing impairment impacting communication * has type 1 diabetes * pregnant or lactating women * alcohol dependency * require multiple daily insulin injections

Keywords: diabetes diabetes technologies telemedicine
a non-interventional prospective study of early her2-negative high-risk breast cancer and brca1/2 mutations prevalence in russia

Conditions: Breast Cancer

Summary: (neo)adjuvant treatment approaches and outcomes


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years old -. signed icf, including patient's consent for genetic testing specimens from primary tumor and blood samples * early her2-negative bc (stages 2 and 3) * compliance with at least 1 of the criteria for brca1/2 testing in accordance with the clinical guidelines of the ministry of health of the russian federation * unknown brcam status or negative brcam pcr test * performed surgical treatment (not more than 7 months before inclusion) -. high risk of recurrence according to one or more criteria: 1. incomplete pathomorphological response (in case of neoadjuvant therapy) 2. cps-eg 3 scale score 3 and more (in case of neoadjuvant therapy) 3. presence of ≥ 4 metastatic lymph nodes in hr+ pts (in case of only adjuvant therapy) 4. ≥pt2 or ≥pn1 in tnbc pts (in case of only adjuvant therapy) 5. any other high risk criterion according to investigators opinion * the presence of postoperative or biopsy ffpe exclusion criteria: * participation in another clinical study with an investigational product during the last 3 months * confirmation that the subject was already included in this study before * absence of a written informed consent form; data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database
anaemetro i.v. infusion 500mg drug use investigation

Conditions: Anaerobic Infection; Infectious Enterocolitis; Amebic Dysentery

Summary: secondary data collection study; safety and effectiveness of anaemetro under japanese medical practice


Eligibility criteria:
inclusion criteria: * patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study. exclusion criteria: * no exclusion criteria are set out in this study.
effect of a myopia prediction system on myopia prevention and control

Conditions: Myopia; Randomized Controlled Trials; Artificial Intelligence (AI)

Summary: the global rise in myopia, particularly among children and adolescents in china, underscores the inadequacy of current prevention strategies, indicating that conventional screening and education alone are insufficient to curb the prevalence. integrating personalized myopia prediction into routine care may enhance risk awareness, promote proactive prevention, and improve adherence to medical advice, ultimately reducing the future burden of high myopia. a myopia prediction system based on artificial intelligence was previously developed, accurately predicting future high myopia risk using efficient, robust, and easily accessible predictive factors, including age, spherical equivalent, and the annual progression of spherical equivalent. this study aims to conduct a prospective, one-year, cluster randomized controlled clinical trial to investigate the effectiveness of this prediction system in preventing and controlling myopia in school-aged children.


Eligibility criteria:
inclusion criteria: * the participant and their guardian voluntarily signed the informed consent form * has the record of eye refraction examination in the past year * aged 9 to 11 years, regardless of gender exclusion criteria: * high myopia(spherical equivalent ≤ -6.00 d) * ocular diseases other than myopia (e.g., strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal diseases). * systemic diseases that may affect vision or visual development (e.g., diabetes or other endocrine disorders, cardiovascular or respiratory diseases, down syndrome)

Keywords: myopia prediction randomized controlled trials artificial intelligence (ai)
exercise for elderly lymphoma patients

Conditions: Elderly Lymphoma Patients

Summary: this pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined exercise training (et) program in adult and elderly lymphoma patients undergoing cancer-treatments.

eligible patients were assigned to the et group. all the patients eligible for exercise but not partiticpating to the et program because of logistical reasons, were considered as the control group. all clinical outcomes were assessed before exercise training (t0), 3 (t1) and 6-months (t2) after the beginning of the exercise.

Eligibility criteria:
inclusion criteria: * ≥18-80 years old, histologically conﬁrmed hl or nhl, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy exclusion criteria: * patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were ≥ 65 years and frail on the basis of comprehensive geriatric assessment

Keywords: exercise training, complementary therapy
intervention for comorbid substance use and bipolar disorders

Conditions: Bipolar Disorder; Substance Use Disorders

Summary: this trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.


Eligibility criteria:
inclusion: * diagnosis of a bipolar-spectrum disorder * diagnosis of a substance use disorder * taking at least one mood-stabilizing medication exclusion: * unable to speak and read english * younger than age 18
a pharmacokinetic evaluation study in healthy volunteers

Conditions: Healthy

Summary: the purpose of this trial is to characterize the pharmacokinetics of ins37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of ins37217 when administered via oral or nasal inhalation.


Eligibility criteria:
inclusion criteria: * are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use * are within 20% of their ideal body weight * are healthy on the basis of a pre-trial physical examination exclusion criteria: * history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening * history of cardiac arrhythmias, any pathological abnormality on the ecg, bronchospasm, diabetes mellitus, thyrotoxicosis, parkinsonism, asthma, copd or cardiovascular disease significant drug allergy * subject with a physical obstruction in the nose * use of concomitant medication other than hormonal contraceptives and multi-vitamins * subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness
tnp-2092 to treat acute bacterial skin and skin structure infection

Conditions: Skin and Subcutaneous Tissue Bacterial Infections; Gram-Positive Bacterial Infections

Summary: the purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of tnp-2092 in adults with absssi suspected or confirmed to be caused by gram-positive pathogens.

this phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of tnp-2092, and vancomycin in adults with absssi suspected or confirmed to be caused by gram-positive pathogens. the duration of the treatment period is a minimum of 7 days and a maximum of 14 days.

Eligibility criteria:
inclusion criteria: * subjects may be included in the study if they meet all of the following inclusion criteria: * males or females, 18 years of age or older; * absssi suspected or confirmed to be caused by gram-positive pathogens, including: * cellulitis/erysipelas; * wound infection; * major cutaneous abscess; * lesion with a minimum surface area of 75 cm2; * capable of giving signed informed consent. exclusion criteria: * subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization: * history or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes; * absssi suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class; * prior administration of systemic antibacterial therapy within 96 hours before randomization; * absssi with suspected or confirmed infection caused by gram-negative or anaerobic organisms; * absssi with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens; * evidence of significant hepatic, hematologic, or immunologic disease; * history or evidence of severe renal disease.

Keywords: tnp-2092 absssi safety efficacy
functional rehabilitation of upper limb apraxia in patients poststroke

Conditions: Stroke; Apraxias

Summary: the purpose of this study is to analyze the effects of a mixed intervention of occupational therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and moderate patients post stroke in comparison to a control group with a traditional health educative protocol.

apraxia is a neurological disorder characterized by a loss of ability to execute and carry out skilled movements and gestures despite intact motor and sensory systems, coordination and comprehension. upper limb apraxia comprises a wide spectrum of higher motor disorders caused by acquired brain disease, affecting the performance of skilled movements carried out by the upper limbs. few data are available on the effectiveness of interventions in this disorder and no exists studies that implement a mixed intervention (rehabilitative and compensatory ) of occupational therapy in these patients at home.

Eligibility criteria:
inclusion criteria: * mild-moderate stroke after two month of the cerebrovascular attack. * upper limb apraxia lasting at least 2 months. * less than 9 points in validated apraxia screen of tulia (ast) following vanbellingen et al., 2010. * voluntary participation. * the neurologist, the occupational therapist and the patient judge the intervention to be necessary. exclusion criteria: * history of apraxia before current stroke. * stroke had occurred less than two months or more than twenty four month ago. * cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in spanish validation of mini-mental state examination (mmse)). * severe aphasia. * previous brain tumour. * history of other previous neurologic disorders. * mother tongue different to spanish. * drugs addiction. * intellectual or learning disorders. * brain damage for traumatism or neurodegenerative process. * a history of serious consciousness impairments * uncooperativeness, presence of orthopedic or other disabling disorders.

Keywords: mesh terms: apraxias apraxia, ideomotor stroke cerebral stroke rehabilitation occupational therapy treatment outcome activities of daily living
gamreg sweden - quality register for gambling and gaming disorders

Conditions: Gambling Disorder; Gaming Disorder

Summary: this is a quality register for the monitoring of clinical assessment and treatment for gambling disorder and gaming disorder in swedish health care. this register is held by region skåne, the health care organization of skåne in southern sweden, and administered by register center south, which is associated with health care services in the southern regions of sweden (the establishment of quality registers in swedish health care relies upon a national legislation). quality registers by themselves do not represent formal research projects. however, future research projects can use quality registers, such as the present one, as a data source for future research projects in case they are approved by an ethics authority. clinical study variables collected in the register include the following (examples): * gender, age, occupation, living conditions * if applicable, types of gambling associated with the treatment needs * if applicable, type of problematic video gaming * type of referral to the present treatment contact * treatment history in psychiatry, social services, enforcement agency * history of suicidal behavior * alcohol and drugs problems requiring assessment or treatment * violence victimization * type of treatment provided to the patient


Eligibility criteria:
inclusion criteria: * all patients assessed and treated at units where treatment of problem gambling or problem gaming is provided exclusion criteria: * patients who - in a standardized opt-out procedure (following standard of national regulation for quality registers) - refuse participation in the quality register
pharmacokinetics and hepatic safety of egcg

Conditions: Uterine Fibroids

Summary: a trial to assess the pharmacokinetics and hepatic safety of egcg in women with and without uterine fibroids.

this will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of egcg with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: egcg daily alone, egcg daily with clomiphene citrate and egcg daily with letrozole. the randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. the pharmacokinetics and hepatic safety of egcg with clomiphene citrate and letrozole are unknown. the trial conducted in women with and without fibroids will allow comparisons between these groups. the results of this study will be used to confirm hepatic safety for the larger multi-center friend study.

Eligibility criteria:
inclusion criteria: 1. healthy women ≥18 to ≤40 years of age with or without uterine fibroids 2. must use a double-barrier method for contraception exclusion criteria: 1. subjects using green tea/egcg within 2 weeks prior to study enrollment 2. known liver disease (defined as ast or alt\>2 times normal, or total bilirubin \>2.5 mg/dl). 3. history of alcohol abuse (defined as \>14 drinks/week) or binge drinking of ≥ 6 drinks at one time). 4. subject using hormonal contraceptives 5. subjects who are pregnant or breastfeeding 6. known hypersensitivity to the study drugs 7. any chronic disease