Kornimate/medical-research-clean huggingface dataset:
auricular muscle zone stimulation for parkinson disease

Conditions: Parkinson Disease

Summary: a multicenter, randomized, blinded, electronic device in subjects with parkison disease.

this study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with parkinson's disease who have the wearing-off phenomenon on oral levodopa therapy. all participants will receive three treatments on different days, each with different stimulation conditions. all subjects will wear the earstim device on the ear ipsilateral to the side of the body more affected by parkinson's disease for 120 minutes during each of the three treatment applications.

Eligibility criteria:
inclusion criteria: 1. subject is a male or female ≥18 years of age. 2. subject has parkinson's disease and is on levodopa therapy. 3. subject experiences off periods with an "on" score ≥20% better than the off score as measured by the mds-updrs motor score (mds-updrs part iii). 4. the subject's daily "off" time duration is ≥2 hours per day. 5. the subject's hoehn-yahr stage when "off" must be less than stage 4 (i.e., subject must be able to walk without the use of an assisted device, such as a cane or a walker). 6. subject receives levodopa at least tid with a minimum of 100 mg levodopa administered with each dose. 7. subject can tolerate 2 hours in an "off" period without requiring rescue medication. 8. subject is willing and able to not change parkinson's disease medications or dosages during the up to 2 week study therapy period. 9. subject is willing to provide informed consent to participate in the study. 10. subject is willing and able to comply with all study procedures and required availability for study visits. exclusion criteria: 1. subject has a medical or psychiatric comorbidity that can compromise participation in the study. 2. subject has cognitive dysfunction defined by a montreal cognitive assessment (moca) score \<24. 3. subject has moderate levodopa-induced dyskinesias as indicated by a score \>2 on items 4.1 and/or 4.2 in the mds-updrs part iv. 4. subject has clinically significant depression as determined by the beck depression inventory-ii score \>15. 5. subject is pregnant as determined by a urine pregnancy test at the screening visit. 6. subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception. 7. subject has a form of parkinsonism other than parkinson's disease, such as drug-induced parkinsonism or multiple system atrophy. 8. subject has an implanted deep brain stimulator (dbs). 9. subject is receiving direct intestinal infusions of levodopa. 10. subject has epilepsy. 11. subject medications are anticipated to change during the two (2) week study period (note: the study requires stable medications during the device testing period). 12. subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.
indonesia frailty, aging, and longitudinal study

Conditions: Frailty; Quality of Life

Summary: frailty is a dynamic process from fit (robust) and pre-frail elderly. there is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in indonesian elderly. this study was aimed to define the risk factors and clinical outcomes of frailty transitional status in indonesian elderly.

frailty is an age-associated, biological syndrome characterized by decreased biological reserves, due to dysregulation of several physiological systems, which puts an individual at risk when facing minor stressors, and is associated with poor outcomes (ie, disability, death, and hospitalization). frailty identifies a high-risk subgroup and offers characteristics of great clinical importance: a higher reversibility at early stages than disability, and a higher predictive value than chronic disease for adverse outcomes at older ages. it is also the most common condition leading to death in community-dwelling older people. however, there is current consensus that physical frailty is potentially reversible. it is hence useful to objectively detect frailty among frail elderly persons, as frailty indices serve a useful purpose for risk stratification, predicting need for institutional care and planning of services needed. to date, there is no study or information about frailty status in indonesia elderly. this study was aimed to define the risk factors and clinical outcomes of frailty transitional status in indonesian elderly.

Eligibility criteria:
inclusion criteria: 1. elderly aged \>= 60 years old 2. fit (robust) or pre-frailty; 3. capable to understand and carry-out the instruction. exclusion criteria: 1. unwilling to join the study; 2. abbreviated mental test (amt) score \< 8; 3. geriatric depression scale (gds) score \>= 10; 4. body mass index (bmi) \<18,5 kg/m2; 5. malnutrition (according to mini nutritional assessment/mna); 6. liver cirrhosis, severe liver dysfunction, or serum alt levels \>3 times upper normal limit; 7. acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale \>6/10), stroke attack, crisis hypertension; 8. severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class iii or iv (new york heart association classification); 9. severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage iii or iv (gold classification), and/or pao2 levels \< 60 mmhg.

Keywords: frailty pre-frailty fit robust elderly sociodemography status functional status cognitive status nutrition status comorbidity polypharmacy mortality depression status health-related quality of life fall incidence hospitality
5-ht3 receptor antagonist and respiratory drive in patients with ards

Conditions: Acute Respiratory Distress Syndrome

Summary: this is a pilot study aimed at acquiring primary physiological data, describing and estimating the effects of a 5-ht3 receptor antagonist (ondansetron) on respiratory drive in patients with acute respiratory distress syndrome (ards). the results of this study will determine the interest and feasibility of assessing the clinical applications of ondansetron in reducing patient self-inflicted lung injury (p-sili) in ards, in subsequent studies.


Eligibility criteria:
inclusion criteria: * adult patient (18-75 years old) * berlin criteria for acute respiratory distress syndrome (ards) (1): * hypoxemic respiratory failure with a patrial pressure of arterial oxygen to fraction of inspired oxygen ratio (pao2:fio2 ratio) \< 300 * bilateral opacities not fully explained by effusions, lung/lobar collapse, or nodules on chest imaging that appeared within 7 days of a known clinical insult * respiratory failure not fully explained by cardiac failure or fluid overload * has been mechanically ventilated \> 48 hours * planned to remain mechanically ventilated for the next 24 hours * currently on pressure support ventilation or planning to go on pressure support ventilation in the next 24 hours exclusion criteria: * having received a 5-ht3 antagonist in the last 24 hours, or planning to use one in the next 24 hours * recently treated for bleeding varices, stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement * severe coagulopathy (platelet count\ 3) * neuromuscular disease that impairs ability to ventilate spontaneously (including c5 or higher spinal cord injury, amyotrophic lateral sclerosis, guillain-barre syndrome or myasthenia gravis) * treating clinician refusal, or unwillingness to commit to pressure support ventilation for at least 6 hours. * pregnancy * liver cirrhosis (child b or c) or other severe impairment of hepatic function * congestive heart failure * bradyarrhythmia (baseline pulse\<55/min) * known long qt syndrome * qtc prolongation\>450 msec, noted on prior or screening ecg, or who are taking medication known to cause qt prolongation * hypersensitivity or other known intolerance to ondansetron or other 5-ht3 antagonists

Keywords: ards ondansetron
preservation of beta-cell function in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

this is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed within the prior 2 months * hba1c \> 7% at the time of inclusion * willing to perform intensive diabetes management * able to comply with treatment and follow-up regimen exclusion criteria: * hba1c \> 8% at time of randomization * creatinine \> 1.5 mg/dl * liver function tests \> 3 times the upper limit of normal * severe anemia * severe proliferative retinopathy * nyha class iii or iv heart failure * active cad or recent (within 6 months) mi * pregnant, willing to get pregnant, or not willing to practice any contraceptive method * non-english speaking * active heavy alcohol or illicit drug users (within past 6 months) * history of lactic acidosis

Keywords: type 2 diabetes mellitus newly diagnosed beta-cell function
exercise controls tumor cell growth through ampk activation

Conditions: Breast Cancer

Summary: the study investigates the explanation for the positive relation found between exercise and breastcancer.


Eligibility criteria:
inclusion criteria: * healthy females age 18-30 * bmi 18-25 * regular period exclusion criteria: * ingestions of any hormones * pregnancy * chronic inflammation * elite athletes

Keywords: breast cancer exercise myokines ampk
correlation between epb entrapment test and ultrasound wrist findings in patients with dequervain's disease

Conditions: De Quervain Disease

Summary: the goal of this observational study is to learn about the correlation between epb entrapment test and ultrasound wrist findings in patients with dequervain's disease the main questions it aims to answer are: * if correlation exist between epb entrapment test and ultrasound wrist findings in patients with dequervain's disease ? * if the the correlation aid in deciding management of patients with dequervain's disease participants will be subjected to * epb entrapment test * ultrasound examination of wrist


Eligibility criteria:
inclusion criteria: * age \>18 * radial side wrist pain * finkelstein test positive * failure of non surgical treatment exclusion criteria: • patients who underwent previous surgical release

Keywords: de quervain's disease anatomical variations epb entrapment test
waitlist-controlled trial of a psychological education program for nurses

Conditions: Psychological Stress

Summary: the purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. the investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.


Eligibility criteria:
inclusion criteria: * must have rn degree * must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit exclusion criteria: * participation in earlier pilot trial of the intervention

Keywords: oncology service nursing staff psychosocial intervention coping skills
a study of adh300004 and 5-fluorouracil in locally advanced, recurrent, or metastatic hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: 5-fluorouracil (5-fu), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (dpd). adh300004 blocks dpd. this study will test the safety and effects of oral adh300004 14 hours prior to oral 5-fu in subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * signed written informed consent * in the phase i portion, asian subjects that are \> or = to 18 years of age * in the phase ii portion, any subjects that are \> or = to 18 years of age * non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (hcc) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein \[afp\] \> 4,000 ng/ml, hepatitis b surface antigen positive or alpha-fetoprotein \[afp\] \> 400 ng/ml, hepatitis b surface antigen negative) * radiologically documented measurable disease * adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing * willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of adh300004 in this study exclusion criteria: * chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry * no more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy) * portal hypertension with bleeding esophageal or gastric varices within the past 3 months * ascites that is refractory to conservative management * inability to take oral medication * active peptic ulcer disease * known hypersensitivity to 5-fu or adh300004 * history of primary brain tumors or brain metastases * previous or concurrent malignancy at another site within the last 5 years * stroke, major surgery, or other major tissue injury within 30 days before study entry

Keywords: cancer tumors neoplasms anticarcinogenic agents antineoplastic agents dihydrouracil dehydrogenase (nadp)
predicting cerebral palsy in infants with white matter injury using mri

Conditions: Cerebral Palsy; Periventricular White Matter Abnormalities

Summary: the goal of this study is to determin the mri features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining mri with artificial intelligence. the main questions it aims to answer are: * how to achieve features on conventional mri associated with cerebral palsy? * how to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional mri and deep learning? researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy. participants will be asked to provide mri data, clinical diagnoses information, and follow-up outcomes.

cerebral palsy (cp) is a common group of movement disorders that often results in disability in children. in the context of cp, the importance of early diagnosis is crucial, but current diagnostic modalities often identify cases after the age of 2 years. after initial screening of infants at high risk for cp by behavioral scoring, magnetic resonance imaging (mri) forms an integral part of the comprehensive evaluation. the training of conventional model of cp risk prediction requires a large investment of time and financial resources. the average sensitivity rate drops to 90%. up to now, deep learning technology has been widely used in tasks related to image-based disease classification and has shown excellent performance. periventricular white matter injury (pvwmi) accounts for the largest proportion of various types of brain injuries in cerebral palsy, and the types of brain injuries in cerebral palsy are rich and complex, posing difficulties and challenges to deep learning models. therefore, this study focuses on pvwmi, the most common type of cerebral palsy, and uses conventional mri to develop a deep learning prediction model for cp in infants aged 6 months to 2 years old.

Eligibility criteria:
inclusion criteria: 1. infants and children at high risk of periventricular white matter injury (pvwmi) (gestational age \<35 weeks, birth weight \<2.6 kg, forceps-assisted delivery/fetal head attraction, apgar score \<7, hypoglycaemia, sepsis, electrolyte disturbances, premature rupture of membranes); 2. those who underwent mri at 6 months of age-2 years, including at least t1wi and t2wi sequences; 3. upon follow-up, the patient's clinical diagnosis: cerebral palsy, other diagnoses that did not develop into cerebral palsy, or inability to confirm the diagnosis). exclusion criteria: 1. incomplete mri images or unreadable images due to motion artefacts; 2. incomplete neurobehavioural assessment data (including: gross motor function).

Keywords: cerebral palsy periventricular white matter injury mri deep learning
safety and immunogenicity study of concomitant versus non concomitant administration of a diphtheria, tetanus, pertussis and poliomyelitis vaccine (repevax) and influenza vaccine (vaxigrip) in subjects aged from 60 years old

Conditions: Diphtheria; Tetanus; Pertussis; Poliomyelitis

Summary: primary objectives: to demonstrate that repevax and vaxigrip administered concomitantly in subjects 60 years of age and older are at least as immunogenic as repevax or vaxigrip administered separately. secondary objectives: •secondary immunogenicity objectives: to describe the immune responses 28 days after concomitant or separate administration of repevax and vaxigrip in subjects 60 years of age and older to describe the immune response of vaxigrip according to european medicines agency criteria in subjects 60 years of age and older (note for guidance, 1997: 28) •secondary safety objective: to describe the safety profile after vaccination in each group


Eligibility criteria:
inclusion criteria: * adults aged ≥60 years * at least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years * no influenza vaccine administered during the last 6 months exclusion criteria: * receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years * receipt of pertussis-containing vaccine or pertussis disease within the last 10 years * receipt of medication / vaccine that may interfere with study assessments * febrile illness or moderate or severe acute illness/infection * history of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances * history of guillain barré syndrome or brachial neuritis following a previous vaccination * history of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or unstable neurological disorders * known or suspected immune dysfunction * thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination * chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine

Keywords: diphtheria tetanus pertussis (acellular, component) diphteria biological / vaccine
diagnostic efficacy of cnn in differentiation of visual field

Conditions: Diagnositic Efficacy of Deep Convolutional Neural Network in Differentiation of Glaucoma Visual Field From Non-glaucoma Visual Field

Summary: glaucoma is currently the leading cause of irreversible blindness in the world. the multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in differentiation of glaucomatous from non-glaucomatous visual field, and to assess its utility in the real world.

glaucoma is the world's leading cause of irreversible blind, characterized by progressive retinal nerve fiber layer thinning and visual field defects. visual field test is one of the gold standards for diagnosis and evaluation of progression of glaucoma. however, there is no universally accepted standard for the interpretation of visual field results, which is subjective and requires a large amount of experience. at present, artificial intelligence has achieved the accuracy comparable to human physicians in the interpretation of medical imaging of many different diseases. previously, we have trained a deep convolutional neural network to read the visual field reports, which has even higher diagnostic efficacy than ophthalmologists. the current multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in differentiation of glaucomatous from non-glaucomatous visual field, compare its performance with ophthalmologists and to assess its utility in the real world.

Eligibility criteria:
inclusion criteria: 1. age≥18; 2. informed consent obtained; 3. diagnosed with specific ocular diseases; 4. able to perform visual field test exclusion criteria: incomplete clinical data to support diagnosis

Keywords: deep convolutional neural network visual field glaucoma
screening and intervention for ais in haikou, hainan province, china

Conditions: AIS

Summary: this is a single-center, prospective, non-randomized, open-label, interventional, real-world study. the mild/moderate ais patients will be recruited through screening of 250,000 primary and secondary school students in haikou, hainan province. the patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.


Eligibility criteria:
inclusion criteria: 1. 9 years ≤ age ≤ 16 years 2. diagnosis of ais 3. 10°≤cobb's angle\<45° 4. signed informed consent form exclusion criteria: 1. with other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders 2. obvious deformity of lower limbs and(or) feet 3. previous or ongoing treatment of ais 4. difficulty to read, understanding, and complete the study questionnaires 5. any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
antithrombotic activities of a novel yoghurt drink: a postprandial study

Conditions: Cardiovascular Diseases

Summary: the project aims to investigate the antithrombotic activity of the novel yoghurt drink enriched with polar lipids derived from ovine milk. the health claims the formulated novel or functional food on efsa guidelines "the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in a particular paragraph 5.4, "claims on reduced platelet aggregation" "platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (cv) risk factors. healthy subjects or participants at very low risk of cv disease normally have non-activated circulating platelets. reducing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g., four weeks) would be a beneficial physiological effect". within this investigation, the postprandial effects of this novel yoghurt drink against platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as described in previously established procedures.


Eligibility criteria:
inclusion criteria: * • healthy subjects need to have their dietary and dairy intake within the range \[1-2 serves per week\] exclusion criteria: * subjects will be excluded from the study if they are * under medication and intake of dietary supplements * treatment for blood clotting disorders or dyslipidaemia