Kornimate/medical-research-clean huggingface dataset:
a study of aerobic exercise for adolescents with subthreshold mood syndromes

Conditions: Depressive Symptoms; Hypomania Nos Single Episode or Unspecified

Summary: this study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children

subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk of developping into depression or bipolar disorder. preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in non-clinical and preclinical population and patients with mood disorders. this randomized controlled trial will investigate short-term (3 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical outcomes of high-risk states.

Eligibility criteria:
inclusion criteria: 1. 2 or more dsm-iv defined depressive symptoms, with one as core symptoms ( lost interest or pleasure in activity or depressed mood), lasting for 1 week. 2. 2 or more dsm-iv defined manic symptoms, last for 4 days, but falling short of the criteria for hypomania; or meeting dsm-5 defined symptoms criteria for hypomania, lasting 2-3 days. 3. non-clinical subjects exclusion criteria: * dsm-iv defined major depressive disorder * dsm-iv defined hypo/mania * history of or current other axis i disorders * diagnosed neurological or musculoskeletal disorder/injury, * uncontrolled cardiovascular or metabolic diseases that are not suitable for running * diagnosed hypertension * other diagnosed serious medical conditions that are not suitable for cycling * severe suicidal ideation * mental retardation * currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week

Keywords: neurocognition high-risk prognosis
intra versus extrahepatic division of right hepatic vein during rightsided hemihepatectomy

Conditions: Reduction of Peroperative Blood Loss During Liver Resection

Summary: intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.


Eligibility criteria:
inclusion criteria: * hepatic lesion amenable to right sided hemihepatectomy. exclusion criteria: * hepatic lesions not suitable for a anatomical right sided hemihepatectomy. * unfit for surgery * unwillingness to participate

Keywords: liver surgery blood loss cusa hepatic transection
imaging neural correlates of ketamine using pet/mr

Conditions: Major Depressive Disorder

Summary: the purpose of this randomized, placebo-controlled study is to investigate pharmacodynamic differences between racemic ketamine and esketamine using functional fluorodeoxyglucose (\[18f\]fdg) positron emission tomography/magnetic resonance imaging (pet/mr) pilot study i: a pilot study with healthy controls will be performed in order to investigate pharmacokinetic behavior and acute behavioral effects of intravenous ketamine infusion. pilot study ii: a pilot study including 15 healthy volunteers will be performed in order to optimize scanning procedures. the pilot study follows a randomized, placebo-controlled, double-blind, cross-over study design. after enrollment into the study all subjects will undergo two \[18f\]fdg pet/ct scans in the course of which they will receive either s-ketamine or placebo during the first scan and the respective other study medication during the second scan.


Eligibility criteria:
inclusion criteria: * general health based on medical history, physical examination and structured clinical interview for the diagnostic and statistical manual of mental disorders (dsm-iv) (scid) * age 18 to 55 years * right-handedness (due to potential lateralization effects of lefthanded subjects) * willingness and competence to sign the informed consent form. exclusion criteria: * current or history of psychiatric or neurological disease * current medical illness requiring treatment * pregnancy or current breastfeeding * current or former substance abuse * diagnosis of an axis-1 psychotic disorder in a first-degree relative * any contraindication for mri (e.g., mr incompatible implants, etc.) including dental implants causing signal artifacts * for subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 millisievert (msv) over the last 10 years must not be exceeded, as specified in the austrian legislation on radiation protection (www.ris.bka.gv.at). accordingly, body weight \>100kg is an exclusion criterion (5.1 megabequerel (mbq)/kg \* 100kg \* 0.019 msv/mbq\* 0.885 = 8.58 msv per scan, the factor 0.885 is considered due to continuous radioligand infusion, see pet scanning). * failure to comply with the study protocol or to follow the instruction of the investigating team.

Keywords: ketamine
rc48-adc in her2-low advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: to evaluate the efficacy and safety of disitamab vedotin (rc48-adc) as salvage treatment in patients with her2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

subjects with her2-low advanced breast cancer were treated with disitamab vedotin as salvage treatment. orr, pfs, os and ae were assessed during the trial. her2-low status is defined as ihc1+ or ihc2+ with negative fish test.

Eligibility criteria:
inclusion criteria: * female patients aged 18-70 years (including 18 years and 70 years) * expected survival ≥12 weeks * ecog 0-1 * histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable * at least one measurable lesion according to the recist 1.1 * no history of antibody-drug conjugate use * up to one previous chemotherapy for advanced disease * available hormone receptor status. hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease * her2-low tumors, defined as ihc1+ or ihc2+ with negative fish test * adequate organ function exclusion criteria: * history of thromboembolic events * uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc. * active infections requiring systemic treatment * pregnant or lactating * presence of brain metastases and/or carcinomatous meningitis
the relationship between segmental trunk control and gross motor performance in low birth weight born infant

Conditions: Early Intervention; Low Birth Weight Infants; Term Infants

Summary: this study aimed to examine the relation between trunk control and gross motor performance in lbw and nbw infants.

preterm infants are observed to have reduced trunk extension in the prone position, rigid postural patterns while reaching a toy, fewer movement reactions, trunk rotation, head control, and muscle tone than term infants. to distinguish between the infant with typical motor development and the one with atypical / abnormal motor development and to follow up the level of their trunk controls is important to identify of the motor development delay in the early stage of life. this cross-sectional study included 42 lbw infants and 43 nbw infants at between 3 and 9 months of age. we investigated the association between the gross motor function and the segmental trunk controls of the lbw infants at the 3-9 months of age compared to nbw infants.

Eligibility criteria:
inclusion criteria: * the written consent given by the parents, * being at 3 to 9 months' corrected age, * gestational age of less than 36 weeks + 6 days, * birth weight of 2000 g or less. exclusion criteria: * infants with any genetic, metabolic, orthopedic congenital abnormalities or chronic diseases and parents' rejection to participate in the study * term infants that presented any type of sensory or motor disorder were excluded.

Keywords: early intervention, trunk control, low birth weight, term
safety, tolerance and pharmacokinetics of thr-1442 in chinese healthy subjects

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the purpose of this study was to investigate safety, tolerability and pharmacokinetics in chinese healthy subjects.

this was a single center, phase 1, open-label sad and mad study designed to assess safety, tolerability and pk of orally administered thr-1442 tablets in chinese healthy adults. subjects were enrolled to receive 20mg thr-1442 tablet in single dose group (20mg\*1 day) and multiple dose group(20mg\*7days). blood samples for thr-1442 plasma concentrations were collected 0h till to 48hours.

Eligibility criteria:
inclusion criteria: 1. be able to understand and be willing to sign informed consent and voluntarily participate in the study; 2. chinese women or men aged 18-45 (including 18 and 45) at the time of screening; 3. men or women who agree to effective contraception from the screening period until 30 days after the last dose in the trial; agree to take at least one effective contraceptive measure; 4. during screening and baseline, male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (bmi) in the range of 19 \~ 25.0kg/m2 (including 19 and 25.0kg/m2), \[bmi = weight (kg) / height 2 (m2)\]; exclusion criteria: 1. according to the judgment of the site investigators, including clinical significant medical history in cns, cv system, respiratory system, blood / hematopoietic system, gastrointestinal system, liver / kidney system，etc; 2. subjects with specific allergic history or allergic constitution such as drugs, food and pollen, or allergic to sglt2 inhibitors or similar drugs; 3. alcoholics (drinking 14 units per week, each unit equivalent to 360ml beer or 150ml wine or 45ml alcohol of 40% alcohol), drug or drug dependence subjects; smokers (smoking \> 5 cigarettes per day or the same amount of other tobacco products); 4. subjects with a history of bladder dysfunction, such as urinary incontinence, frequent urination or nocturia; 5. blood donation within 3 months before screening, including component blood or massive blood loss (≥ 200ml), receiving blood transfusion or using blood products; 6. subjects who used prescription drugs, traditional chinese medicine, over-the-counter drugs (otc), vitamins, dietary supplements or supplements (e.g. ginseng) within 4 weeks before the first administration; 7. from 7 days before the first dose to the whole study period, subjects who are unwilling or unable to guarantee to forbid by the following: no smoking, no alcohol, no caffeine containing products (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise; 8. those who are unwilling or unable to guarantee to forbid pitaya, grapefruit, mango, carambola, fruit juice and spicy food containing the above fruits from 7 days before taking the medicine and the whole test period; 9. the subject was unable to swallow the study drug or had gastrointestinal diseases leading to absorption disorders; 10. subjects who had participated in any drug or medical device clinical trial within 3 months before screening;
physiological complexity of gait over the first six months post stroke

Conditions: Stroke, Acute

Summary: physiological complexity of gait, a measure of the interaction of multiple control mechanisms for walking within a biological system, is decreased in persons with chronic stroke compared to those without disability. thus, it is assumed that the quantification of gait complexity represents the adaptability and health of the individual. however, it is unknown if the level of gait-related complexity improves over time with recovery from stroke. therefore, the primary purpose of this study is to determine if the physiological complexity of gait changes over the first six months post stroke within the contemporary healthcare environment. secondary aims include 1) determining if there is a difference between the amount of physiological complexity of gait and lateralization of hemispheric damage after stroke and 2) exploring the relationship of complexity to lower extremity motor impairment, walking speed and balance. sixty individuals within one month post stroke from the greater indianapolis area will be recruited for this prospective, longitudinal outcomes study. testing sessions will occur at intervals across the first six months post stroke: within 1 month, at 3 months, and at 6 months post stroke. during each testing session, participants will complete a 2-minute walking task during which accelerometer signals from wireless inertial measurement units will be collected and converted to sample entropy to quantify the physiological complexity of gait. additionally, measures to quantify lower extremity motor impairment, walking speed and balance will be collected and analyzed. changes in complexity of gait from early to later stages of stroke recovery may serve as a foundation for prognosticating outcomes, such as predicting capacity for community mobility and/or risk of fall. the proposed study will meet a critical need to develop methods that differentiate among capacities for adapting movement patterns in individuals with neurological dysfunction. this work will ultimately build upon evidence that will assist therapists in tailoring interventions in such a way to optimize function.


Eligibility criteria:
inclusion criteria: * within 1-month post unilateral, cortical, ischemic stroke * has only experienced one stroke * between the ages of 21-80 * able to walk a short distance (at least 14 meters) on level surfaces without physical assistance, with or without the use of an assistive device and/or orthosis * able to follow at least two-step verbal instructions * available for the entire period of the study (5-6 months) exclusion criteria: * hemorrhagic stroke * bilateral hemispheric stroke * stroke in the brainstem or cerebellum * pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke * complications from other health conditions that could influence walking

Keywords: stroke, acute; gait, complexity
lung cancer rehabilitation study

Conditions: Non Small Cell Lung Cancer

Summary: patients suffering from non small cell lung cancer(nsclc), depend upon lung removal to increase their chances of survival. but, this type of surgery cannot be advised to patients with significant heart disease, limited lung fuction or reduced physical fitness. intensive physical training has been shown to increase aerobic fitness in healthy subjects. the purpose of this study is to determine the effect of a short term rehabilitation prior to surgery on the post-operative and physiological outcomes for patients undergoing this type of surgery.

for patients with non small cell lung cancer (nsclc), lung resection surgery is the only treatment option which increases survival. however, surgery can not be offered to those with significant heart disease, limited lung function or lacking physical fitness. these are all major risk factors for operative outcome. cardio-pulmonary exercise testing (cpet) allows direct measurement of aerobic physical fitness through maximal oxygen consumption (vo2 max). a recent update of professional guidelines (ers/ests) has emphasized the importance of cpet in preoperative risk stratification of patients with nsclc. interestingly, intensive physical training has been shown to increase aerobic fitness in animals and healthy subjects whereas improvement of vo2 max has been observed in preliminary pilot studies conducted in patients undergoing surgery for nsclc. however, the net effect of short-term, intensive, outpatient rehabilitation on clinically relevant outcomes, such as major post-operative cardio-pulmonary complications, as well as physiological outcomes is unknown. objectives: 1. to assess the physiological effect of 3 weeks of intensive physical training in patients eligible for nsclc surgery. 2. to assess the effect of physical training on post-operative outcomes. 3. to identify the clinical variables, laboratory tests and specific gene polymorphisms (snps) associated with these outcomes.

Eligibility criteria:
inclusion criteria: proven or suspected lung cancer, stage iii a or less (eligible for surgical cure), documented by ct-scan or positron emission tomography ct scan (pet-ct) exclusion criteria: * contra-indication to perform cardio-pulmonary exercise test (uncontrolled cardiac disease, severe pulmonary hypertension, osteo-articular limitations impeding cycling) * inability to adhere to rehabilitation program (because of clinically limiting comorbidity, psychiatric condition or osteoarthritis) * clinically limiting or untreated heart disease

Keywords: nsclc, rehabilitation, cpet, lung resection
vitamin d status in pediatric asthma

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to evaluate level of vitamin d in pediatric asthma and relationship between vitamin d and level control of asthma.

cross-sectional study

Eligibility criteria:
inclusion criteria: * children between the age of 6 years and 18 years with the diagnosis of asthma who are attending the outpatient pediatric department, pediatric allergy clinic exclusion criteria: * patients who have chronic pulmonary, heart disease, chronic renal failure, liver disease, endrocrine disorder, or receieve antiepileptic drugs, vitamin d supplement

Keywords: vitamin d asthma
a retrospective, observational study of roactemra/actemra (tocilizumab) in clinical practice in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with roactemra/actemra (tocilizumab). no actual patient will be enrolled in this study; data will be collected from medical records.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age * diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a das28 \>=5.1 * inadequate responder to at least 2 non-biological dmards * absence of documented erosions at start of roactemra/actemra treatment * received roactemra/actemra treatment for at least 6 months * availability of data from at least the roactemra/actemra treatment initiation visit and the 6 months visit exclusion criteria: * contraindications for treatment with roactemra/actemra
medications for obstructive sleep apnea in children with down syndrome

Conditions: Obstructive Sleep Apnea; Down Syndrome

Summary: this is a randomized, double blind, cross-over study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with ds and osa documented by polysomnography (psg). participants will receive high dose ato-oxy for four weeks as well as low dose ato-oxy for four weeks in random order. during the high dose ato-oxy period, participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine nightly for one week. atomoxetine dose will then be increased to 1.2 mg/kg/day (max 80 mg). during the low dose ato-oxy period, participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. dosing of the study treatment will occur approximately 30 minutes prior to bedtime. participants who withdraw from the study will not be replaced. study participants will undergo eligibility screening that will include an initial screening to determine whether non- psg enrollment criteria are met, followed by a 1 night in-lab psg and health-related quality of life assessment for participants who qualify based on non-psg criteria. for participants who are eligible and enroll in the study, the screening psg night will serve as the baseline measure for apnea hypopnea index (ahi) and other psg endpoints. on the final night of dosing for both high dose ato-oxy and low-dose ato-oxy, participants will return for inpatient psg and health-related quality of life assessment. the primary efficacy endpoint is the change in obstructive ahi from baseline (high dose ato-oxy vs. low dose ato-oxy).


Eligibility criteria:
inclusion criteria: 1. male or female participants between 6 to 17 years of age, inclusive, at the screening visit. enrollment will be stratified to ensure equal representation of children age 6-12 and age 13-17. no more than 14 subjects will be randomized for each age group. 2. known diagnosis of down syndrome (trisomy 21, but not translocation or mosaicism) exclusion criteria: 1. hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation \<90%) 2. presence of central sleep apnea on polysomnography (central ahi ≥ 5) 3. currently using and adherent to pap therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 4. mao inhibitor use 5. urinary retention 6. prematurity \< 37 weeks estimated gestational age 7. seizure disorder 8. untreated or inadequately treated hypothyroidism 9. significant traumatic brain injury 10. congenital heart disease and not cleared to participate by the patient's cardiologist 11. history of current, untreated depression 12. history of liver disease 13. 3+ or greater tonsillar hypertrophy.

Keywords: atomoxetine oxybutynin
aprepitant without steroid in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer

Conditions: Chemotherapy-induced Nausea and Vomiting; Colorectal Cancer

Summary: addition of aprepitant, an nk1 receptor antagonist to a 5-ht3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (cinv) with moderately emetogenic chemotherapy (mec). little is known about the efficacy of aprepitant when used without dexamethasone. dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. however, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. this randomized phase iii trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving folfox(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of colorectal cancer * no prior chemotherapy and scheduled to receive folfox chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil) * age ≥18 years * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * laboratory index: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days), absolute neutrophil count ≥ 1.5×10\^9/l, platelet count ≥ 75×10\^9/l, serum bilirubin ≤ 1.5×uln, alt and ast ≤ 3.0×uln (without liver metastases), alt and ast ≤ 5.0×uln (with liver metastases), serum creatinine ≤ 1×uln, endogenous creatinine clearance\>60ml/min * be able to read, understand and complete the questionnaire and diary * be able to understand the study procedures and sign informed consent. exclusion criteria: * treatment with any other study medicine within 4 weeks before enrollment. * nausea or vomiting ≤ 24 hours prior to registration * ongoing emesis due to obstruction of digestive tract * concurrent use of olanzapine, phenothiazine or amifostine * female with pregnancy or lactation * severe cognitive compromise * known history of cns disease (e.g. brain metastases, seizure disorder) * concurrent abdominal radiotherapy * chronic alcoholism * known hypersensitivity to aprepitant, tropisetron, or dexamethasone. * known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. * history of uncontrolled diabetes mellitus * serious or uncontroled infection * known active hiv, viral hepatitis or tuberculosis infections