Kornimate/medical-research-clean huggingface dataset:
reliability of sensor-derived measurements of the sensorized fugl-meyer (fma) in subjects with stroke outcomes

Conditions: Stroke; Sensorimotor Impairment Affecting the Upper Limb; 18 Years and Over

Summary: this study will be conducted at a single research center, the main objective of the study will be to evaluate the efficacy, safety, and accuracy of a medical device that has not yet been commercialized; therefore, it is still under development or testing and is not yet available for private use and is not for profit (nonprofit). fifty participants will be recruited from subjects afferent to the outpatient and inpatient neuro-motor rehabilitation clinics of irccs fondazione don carlo gnocchi in florence, italy, and afferent to the outpatient and inpatient rehabilitation clinics of elias university emergency hospital in bucharest, romania. in detail, it is deemed necessary to collect clinical and instrumental data. the study will be conducted by an interdisciplinary team composed of healthcare professionals and engineers afferent to the department of industrial engineering. should you decide to participate in the study, a visit to verify the inclusion and exclusion criteria will be primarily conducted. once the admission criteria have been verified, participants will undergo a series of assessments. the first, involves the administration of some specific sections of the fugl-meyer scale (fma), focusing on the upper extremities. specifically, the following will be examined: section a for general upper limb function, section b assessing wrist mobility, and finally section d for limb coordination and speed. during this phase, both upper limbs will be assessed, in addition, the first examiner will carefully place sensors on the participants and assign scores to the tests performed, according to the criteria established by the fma scale. next, a second assessment (t1) will be conducted, in which a second examiner will be responsible for placing the sensors and recording data only on the most affected side. at a third time, called "t2" and again with at least 15 minutes interval from t1, the first examiner will repeat the same assessments performed in "t1." while performing these assessments, a realsense camera will be used.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * stroke outcomes with the presence of sensorimotor impairment in the upper limb; * willingness to participate in the project, with informed consent signed by the person himself or, when necessary, by the support administrator/legal guardian. exclusion criteria: * severe concomitant pathologies that modify the subject's motor framework; * severe visual and/or hearing impairments that cannot be corrected; * severe neuropsychological impairments (aphasia, apraxia, other cognitive deficits ) such as to prevent cooperation in administering the scale; * presence of signs of clinical instability, defined by a score greater than zero on the sic scale (clinical instability scale).
evaluation of the nella women's care line

Conditions: GYN Disorders

Summary: evaluation of the nella women's care line

the nella women's care line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix.

Eligibility criteria:
general inclusion criteria (applies to all study groups): * subject is female * subject is 18 - 65 years of age, inclusive, at the time of consent * subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care * subject has undergone one or more prior gynecological exams * subject is willing and able to provide written informed consent * subject is able and willing to perform the functions required by the study protocol general exclusion criteria (applies to all study groups): * subject has undergone hysterectomy * subject has a known history of allergies to latex or plastics * subject is pregnant * subject is post-partum (≤ 12 weeks) * subject has had an induced or spontaneous abortion in the prior 12 weeks * subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results * subject has dyspareunia * subject has a known history of vulvodynia such as vulvular vestibular syndrome * subject has a known history of vaginismus * subject has a planned surgical procedure along with the gynecological exam * subject is under incarceration * subject is unable to provide written informed consent device specific inclusion criteria: in addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. below are device-specific criteria. there is no device-specific exclusion criterion. nella vusleeve (group 1) inclusion: • subject has a bmi ≥ 30 and/or 3 or more vaginal births nellaspec (group 2), nella nuspec (group 3), and nella insert (group 4) inclusion: • subject has a bmi \< 35
hepasphere interventional therapy using digital subtraction angiography（dsa） for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of hepasphere interventional therapy using digital subtraction angiography（dsa）for pancreatic cancer.

by enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of hepasphere interventional therapy using digital subtraction angiography（dsa）for pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. karnofsky performance status \>60 3. diagnosis of pancreatic cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive interventional therapy 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except pancreatic cancer 2. history of coagulation disorders or anemia

Keywords: pancreatic cancer hepasphere
infections in pediatric cancer patients

Conditions: Infections

Summary: a prospective epidemiological study conducted in pediatric hematology oncology center in hadassah medical center. the study will include all newly diagnosed pediatric cancer patients age 0-18 years admitted with fever during chemotherapy. in each event of febrile episode during chemotherapy, the following data will be collected using a patient data form and computerized software. demographic data: age, gender, ethnicity. clinical data: underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event. imaging data microbiological data outcome the statistical analysis will be performed by an epidemiologist and statistician using the spss 12.0 software.


Eligibility criteria:
inclusion criteria: * pediatric cancer patients age 0-18 years admitted with fever during or following chemotherapy exclusion criteria: * no exclusions

Keywords: fever children cancer leukemia stem cell transplantation infections in pediatric cancer patients presenting with fever during or following chemotherapy.
mitochondrial dysfunction in phelan-mcdermid syndrome

Conditions: Phelan-McDermid Syndrome

Summary: the purpose of this study is to determine whether a relationship exists between gene deletion(s) specific to the mitochondrial electron transport chain and presentation of clinical characteristics in patients with phelan-mcdermid syndrome (pms).

phelan-mcdermid syndrome (pms) results from a deletion within the 22q13 chromosome region. most children have specific physical morphology and developmental delays with many displaying characteristics of autism spectrum disorder (asd) including abnormalities in social development. the behavioral aspect of pms that parallels asd has raised particular interest as the shank3 gene, which lies in the 22q13 region, is important for synaptic development, and animal shank3 knockout models demonstrate asd characteristics thereby confirming the importance of this gene in pms. however, despite the importance of the shank3 gene, individuals with pms have variations in their development, behavior and medical characteristics that cannot be fully explained by the shank3 deletion. recently, frye (2012) has noted the existence of 6 mitochondrial genes that lie slightly proximal to the shank3 gene within the 22q13 region. these include genes important electron transport change function (sco2, ndufa6), mitochondrial dna (tymp) and rna (trmu) metabolism, fatty acid metabolism (cpt1b) and tricarboxylic acid cycle function (aco2). since most individuals with pms have deletions that include chromosomal deletion outside of the shank3 region, it is very likely that many, if not most, of children with pms may have deletions in these mitochondrial genes. many of these genes have been linked to mitochondrial disease, even in the heterozygous state. even if recognized, mitochondrial disease is only linked to a homozygous abnormal state (autosomal recessive), the loss of one gene (heterozygous state) could result in symptomatology when associated with deletions in other mitochondrial or non-mitochondrial genes. abnormalities in mitochondrial pathways can result in neurologic and non-neurologic symptoms including those sometimes seen in children with pms. added with the shank3 deletion, abnormalities in these mitochondrial genes could explain variations in patterns of development and the eventual cognitive potential. references: frye re. mitochondrial disease in 22q13 duplication syndrome. j child neurol. 2012; 27(7):942-9.

Eligibility criteria:
inclusion criteria: * 1-21 years of age * diagnosed with phelan-mcdermid syndrome and diagnosed with mitochondrial disorder * diagnosed with phelan-mcdermid syndrome exclusion criteria: * none

Keywords: electron transport chain mitochondrial disease chromosomal deletion
evaluate the efficacy of amg 706 to treat advanced gastrointestinal stromal tumors

Conditions: Advanced Gastrointestinal Stromal Tumor

Summary: the purpose of the study is to evaluate the safety and efficacy of amg 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.


Eligibility criteria:
inclusion criteria: * diagnosis of histological confirmed gist * had prior imatinib mesylate therapy * has at least 1 measurable leasion by modified recist exclusion criteria: * central nervous system tumor involvement requiring treatment * history of myocardial infraction * uncontrolled hypertension

Keywords: gastrointestinal stromal tumor, imatinib mesylate resistance, phase2 study, amg 706
mass balance study of mt-1303

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the purpose of this study is to investigate the absorption, metabolism and excretion of mt-1303 in healthy subjects.


Eligibility criteria:
inclusion criteria: * caucasian male aged 30 to 65 at screening. * body weight of ≥60 kg, and a bmi ranging from 18.0 to 32.0 kg/m2 at screening and day -1. * normal or not clinically significant ecg as defined by a hr between 50 and 100 bpm inclusive at screening, day -1 and pre-dose. * vital signs within the following ranges at screening and day -1,body temperature: 35.0 to 37.5 °c,sbp: 90 to 140 mmhg,dbp: 50 to 90 mmhg. * regular daily bowel movements. exclusion criteria: * radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 msv in the last 12 months or 10 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study. * previous medical history of tuberculosis, or in the opinion of the investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections. * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. the investigator should be guided by evidence of any of the following: * history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding; * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
study on gut microbiota in chronic hbv infected patients

Conditions: Chronic Hepatitis B Infection; Healthy

Summary: hepatitis b virus(hbv) infection is a common infectious disease affecting up to 2 billion people worldwide. around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis b every year. age is the main factor affecting the chronicity of hepatitis b, while 90% and 25% to 30% of hepatitis b virus(hbv) infection in perinatal and infant period will develop into chronic infection respectively. whereas the proportion in patients above 5 years old is only 5% to 10%. intestinal microbiota plays an important role in maintaining nomal physiological function of the intestine and the immune function of the body. it has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. recently, the relationship between immune response and intestinal microbiota has been claimed. in a previous study using imt to treat hbeag positive chronic hepatits b patients combined with antiviral theraopy, 80% of them has reached hbeag clearance. increasing evidence suggests that the gut microbiota has evolved as a new important player in the pathogenesis of hepatitis b virus-induced chronic liver disease. however, the composition and structure alteration of the gut microbiota associated with the stage and progression of hbv infection remains unknown. hence, we proposed a trial to detected gut microbiota of chronic hbv infected patients high-throughput 16s rrna gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.


Eligibility criteria:
inclusion criteria: 1. alcohol free history or alcohol consumption \<140g per week in male, \<70g per week in female 2. smooth and soft stool like sausage or snake 3. voluntary participate in this study exclusion criteria: 1. syptom of digestive system disorder such as hematochezia, constipation, abdominal distention, abdominal pain, diarrhea and jaundice within 1 month 2. abormal results of several tests including: fecal routine, fecal occult blood test 3. be diagnosed as enteritis within 1 month 4. chronic obstructive pulmonary disease, renal insufficiency and other systemic diseases. 5. autoimmune disease 6. chronic fatigue syndrome and neuropsychic disease 7. a history of antibiotics, microecological preparation, gastrointestinal motility medicine, laxative, weight loss drug, glucose lowering, blood fat regulation, glucocorticoid or immunosuppressor treatment within 1 month 8. history of organic diseases in digestive system such as gastrointestinal polyposis, ulcers, malignancies, etc. 9. history of gastrointestinal surgery
blood sugar response to commercial nutritional supplements in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of the study is to determine which of the commonly used meal supplements is the best product for patients with dm. this is important because meal supplements are becoming more popular as meal replacements in the united states. peak blood sugar occurs about 2 hours later after a meal. therefore, the best product would be the one that produces a smallest rise in blood sugar.

the purpose of the study is to determine which of the commonly used commercial nutritional supplements are preferential for patients with diabetes mellitus (dm). we will compare the post-prandial blood glucose (bg) responses in response to 3 different nutritional supplements each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and relate these responses to one of the two well-recognized indices of insulin sensitivity - homa-r and quicki.

Eligibility criteria:
inclusion criteria: * ages 18-75 years * type-2 diabetes mellitus for over 3 months * a1c of 7.0 - 10.0% within the past 3 months * controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. metformin and/or pioglitazone * able to give informed consent * expected to be in the dc metropolitan for the duration of the study * fasting blood glucose between 70 and 250 mg/dl exclusion criteria: * patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (symlin), glp-1 analogs (byetta), insulin, or alpha-glycosidase inhibitors * a1c under 7.0% or over 10.0% * fasting blood glucose \ 250 mg/d * gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency. * clinical history of documented gastroperesis. * patients on hemodialysis or peritoneal dialysis * pregnancy * inability to read and/or speak english
ultrasound evaluation of cardiac function during spontaneous breathing trials

Conditions: Weaning Invasive Mechanical Ventilation; Weaning-induced Pulmonary Edema; Weaning Failure of Mechanical Ventilation; Spontaneous Breathing Test; Intensive Care Units (ICUs)

Summary: the goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (e/e') during 3 spontaneous breathing trials in intensive care unit (icu) adults (over 18 years) patients at risk for weaning failure. the main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work. investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others. participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. during these trials, the investigator will perform cardiac ultrasound measurements.


Eligibility criteria:
inclusion criteria: * intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial * richmond agitation sedation scale (rass) between -1 and +1 * patient at high risk of re-intubation with at least one of the following criteria: * underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema) * underlying respiratory disease (copd, emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease) exclusion criteria: * neuromuscular pathology (myasthenia type) preceding hospitalization * pregnant or breast-feeding women * patient already included in the study * protected person (under guardianship or curatorship) * person under court protection * person not affiliated to a social security scheme

Keywords: humidified high flow cardiac ultrasound spontaneous breathing trial t-piece
association of periostin levels and chronic sinusitis

Conditions: Sinusitis; Nasal Polyps

Summary: the purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. this protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. the investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. all patients enrolled in this study will have chronic sinusitis without asthma.


Eligibility criteria:
inclusion criteria: * patients with sinus disease which requires surgical intervention * ability to understand and give informed consent exclusion criteria: * previous diagnosis of asthma * positive methacholine challenge at screening * diagnosis of cystic fibrosis * concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)

Keywords: chronic sinusitis nasal polyps
a study of tirzepatide (ly3298176) once weekly in adolescent participants who have obesity or overweight with weight-related comorbidities

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. the study will last approximately 90 weeks and may include up to 25 visits.


Eligibility criteria:
inclusion criteria: * have obesity, as defined by bmi equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, or * have overweight, as defined by bmi equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity. * dyslipidemia * pre-hypertension * hypertension * nonalcoholic fatty liver disease * obstructive sleep apnea * prediabetes * documented preexisting condition of type 2 diabetes participants with type 2 diabetes mellitus (t2dm) * have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a hba1c\<9.0% exclusion criteria: * have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records. * have type 1 diabetes * have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction. * are prepubertal (tanner stage 1). * have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2 * have a history of chronic or acute pancreatitis. * have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as lap-band gastric banding, or * any other procedure intended to result in weight reduction.