Kornimate/medical-research-clean huggingface dataset:
parcopa versus carbidopa-levodopa in a single dose cross-over comparison study

Conditions: Parkinson's Disease

Summary: to find out if a single dose of parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating pd patients.

this is a study to compare orally dissolving levodopa (parcopa) to the conventional immediate release oral levodopa. this is a single-dose, double-blind, placebo controlled crossover trial in participants with parkinson disease.

Eligibility criteria:
inclusion criteria: * male or female between the age of 31 and 80 -diagnosis of idiopathic parkinson's disease for at least three years duration * patients requiring levodopa for their pd * good subjective response to levodopa * fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures * a updrs -off- motor score of at least 25 * subjects willing to give informed consent * subjects who are able and willing to comply with study procedures * if female of child-bearing potential, will use one of the approved birth control measures: 1. hormonal contraceptives 2. spermicidal and barrier 3. intrauterine device 4. partner sterility exclusion criteria: * subjects with evidence of significant dementia * subjects with significant oral lesions * history of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry * history of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions * history of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry. * subjects with poor response to levodopa * women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.

Keywords: parkinson's disease time to "on" delayed on
clinical validation of ai-assisted radiotherapy contouring software for thoracic organs at risk

Conditions: Lung Cancer; Breast Cancer; Esophageal Cancer

Summary: the goal of this clinical trial is to evaluate performance and clinical applicability of ai-assisted radiotherapy contouring software for thoracic organs at risk. the main question it aims to answer is: • does ai-assisted contouring (ai contouring with manual modification) offer greater accuracy and time efficiency compared to manual contouring? after screening, the qualified participants' thoracic ct images will be anonymized and segmented using three methods: manual, ai (ai-only), and ai-assisted contouring. the researchers will compare the results generated by the three different contouring methods with the ground truth established by expert consensus, in order to evaluate both accuracy and time-related parameters


Eligibility criteria:
inclusion criteria: 1. ≥18 years old, no gender limit. 2. patients diagnosed with breast cancer, lung cancer, or esophageal cancer, who are scheduled for chest ct scanning followed by thoracic radiotherapy. 3. ct slice thickness ≤5mm. 4. patients understand the goal of the trial, are willing to attend the trial and sign the informed consent. exclusion criteria: 1. congenital malformations or abnormal anatomical structures resulting from non-tumor factors in the scan area. 2. artifact, prosthesis or implantation causing images undistinguishable. 3. ct images not conforming to dicom standards. 4. investigators consider not suitable.

Keywords: artificial intelligence radiotherapy contouring thoracic organs at risk
application of serial body composition change for risk prediction in treating patients with severe pneumonia

Conditions: Pneumonia

Summary: we hypothesize that serial changes of body composition in patients with pneumonia can help clinician to monitor prognosis. it was associated with underlying immune response.

specific aims: 1. can serial body composition data be useful for predicting outcomes of patients with pneumonia? (developing sepsis, organ failure, admission to icu, length of icu, survival, length of stay in hospital, prolonged mechanical ventilation,..) 2. can serial body composition data be integrated into both immune status alternatives (e.g., white blood cell (wbc) count, segment/monocyte ratio, pulse pressure) in such critical illness and monitoring responses (sofa score, labs) for severe pneumonia patients? 3. can serial body composition data reflect clinical variables in patients with pneumonia, and even altered by nutrition intake? (e.g., compare association between nutrition intake amount and groups stratified by body composition, blood pressure, nutritional intake, ...)

Eligibility criteria:
inclusion criteria: adult patients with pneumonia admitted to the thoracic ward or medical intensive care unit of kaohsiung chang gung memorial hospital exclusion criteria: -

Keywords: pneumonia, sepsis, body composition
a multi-disciplinary technology-based care for diabetic ketoacidosis in patients with type 1 diabetes

Conditions: Diabetic Ketoacidosis

Summary: the study team proposes that use of a novel multi-disciplinary approach with continuous glucose monitoring technology can significantly improve glycemic control and reduce readmissions among those with type 1 diabetes mellitus (t1dm) admitted for diabetic ketoacidosis (dka). this will also help promote a pathway for care of these patients after admission utilizing resources which are available within the endocrinology, diabetes and metabolism department at the cleveland clinic.

diabetic ketoacidosis (dka) is a serious complication of type 1 diabetes mellitus (t1dm) with significant cost to the united states of $2.2 billion over the past decade. readmissions are very common with a 20.2% readmission rate within 30 days of discharge and 86% of those admitted with dka having a subsequent 1-3 admissions in the following year. while predictors have been identified (i.e. lower socioeconomic status, medicaid/medicare, younger age, female, leaving against medical advice, etc.), few interventions have been able to concretely show a reduction in the rate of readmission apart from endocrinology consultation. very few studies have assessed the use of a multi-disciplinary approach in this context. the only study in adults with t1dm which made use of such a team (i.e. ketoacidosis case manager, educators to provide immediate post-discharge contact and follow up along with behavioral health, education and endocrinology follow up) was done in the uk and was able to show significant improvement in readmission and glycemic control over the year-long intervention, but notably had to shut down due to lack of funding. none of these interventions consistently applied technology (i.e. continuous glucose monitoring \[cgm\]) which is known to be able to significantly improve glycemic control within the first month of use in those with poorly controlled t1dm.

Eligibility criteria:
inclusion criteria: * age 18 years old or older * diagnosis of type 1 diabetes * admitted to the hospital with confirmed diabetic ketoacidosis treated with intravenous insulin infusion * no prior use of continuous glucose monitoring (cgm) * compatible smart phone with cgm * allergy to any component of the cgm exclusion criteria: * condition which, in investigator judgement would limit their ability to participate safely
echocardiographic changes after 3-hydroxy butyrate+whey intake

Conditions: Cardiac Output; Endotoxemia; Catabolic State; Echocardiography

Summary: this study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-ohb) to whey protein during human endotoxemia. further, this study compares cardiovascular changes during healthy and catabolic conditions. participants will receive isocaloric, isonitrogenous beverages of either whey or 3-ohb+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).

background: a newly published study found beneficial cardiovascular effects of 3-ohb infusion in a population with chronic heart failure, significantly increasing cardiac output. similar effects on cardiac output were observed in healthy volunteers. these findings pave the way for 3-ohb as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. however, it is unknown whether the cardiovascular effects of 3-ohb persist during a sepsis-like catabolic state and when administered orally. aim: this study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-ohb) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast. hypothesis: 1. adding the ketone body 3-ohb to an oral protein supplement increases cardiac output measures 2. catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular changes compared with healthy conditions (overnight fast) interventions: in a randomized crossover design, eight healthy, lean, young men will undergo either: i) healthy conditions (overnight fast) + whey protein\^ ii) catabolic conditions (inflammation (lps) + 36-hour fast and bed rest\*) + whey protein\^ iii) catabolic conditions (inflammation (lps) + 36-hour fast and bed rest\*) + 3-ohb/whey protein\^" \*lps will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. on the study day lps (0.5 ng/kg) will be injected. \^beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. bolus/sip administration will be applied (1/3 bolus, 1/2 sip) " 50 grams of 3-ohb will be orally administered (1/2 bolus, 1/2 sip)

Eligibility criteria:
inclusion criteria: * between 20-40 years of age * body mass index between 20-30 kg/m\^2 * healthy * oral and written consent forms obtained prior to study day exclusion criteria: * recent immobilization of an extremity that is not fully rehabilitated * lactose, lidocain or rubber allergies * current disease * use of anabolic steroids * smoking * former major abdominal surgery (or current problems with the gi tract) •\>10 hours of exercise/weak * present ketogenic diets or high-protein diets * blood doner that does not want to discontinue blood donations until study completion * pending mr scan

Keywords: cardiac output endotoxemia ketone bodies 3-hydroxy butyrate whey protein catabolic state
bioequivalence of oral formulations of anastrozole in healthy chinese volunteers under fed condition

Conditions: Healthy Volunteers

Summary: an open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy chinese volunteers under fed conditions to assess the bioequivalence between two formulations of anastrozole.

anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. a generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.the aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. a total of 26 healthy chinese female subjects were randomized to receive a single dose of 1.0-mg test and reference formulations of anastrozole within 30 min after beginning the consumption of a recommended high-fat, high-calorie breakfast (150 calories from protein, 250 calories from carbohydrate, and 500-600 calories from fat; total calories approximately 800-1000).this was repeated two times, separated by a 21-day washout period.blood samples (3 ml) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1.5, 2, 2h20min, 2h40min, 3, 3.5, 4, 4.5, 5, 7, 12, 24, 48 and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. the evaluated pharmacokinetic parameters, including cmax, auc0-t, auc0-∞,were assessed for bioequivalence based on current guidelines.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal volunteers aged between 18 and 65 years old. * the body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). the weight is not less than 45 kg. * the subjects have no family planning within 6 months and could select contraceptive method. * subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment. exclusion criteria: * meet the diagnostic criteria for osteoporosis. * subjects with vaginal bleeding. * blood donation, massive blood loss (#400ml) or enrolled in other clinical trials 3 months prior to screening. * any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study. * any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week); * smoking more than 5 cigarettes per day during the 3 months prior to screening;
genetic an functional studies of patient with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: the objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (crohn's disease) or crohn's disease (cd), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of ibd


Eligibility criteria:
inclusion criteria: * patient with definite crohn's disease or ulcerative colitis exclusion criteria: * patient receiving anti-tnf therapy during 14 days before inclusion.

Keywords: crohn disease ulcerative colitis genetic makers cytokines
pulmicort respules 0.25/0.5 specific clinical experience investigation

Conditions: Bronchial Asthma

Summary: the purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and \< 5 years on bronchial asthma in daily clinical usage.


Eligibility criteria:
inclusion criteria: * patients treated with pulmicort respules for the first time due to bronchial asthma * children of \>= 6 months and \< 5 years old age at the start of study treatment

Keywords: bronchial asthma pulmicort respules long term use pediatrics
effects of different doses of dexmedetomidine on fentanyl-induced cough

Conditions: Fentanyl-induced Cough

Summary: the investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction. patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups i, ii, iii, and iv, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. the incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.


Eligibility criteria:
inclusion criteria: * patients undergoing elective surgeries under general anesthesia. exclusion criteria: * patients with contraindications of dexmedetomidine. * patients younger than 18 years old and older than 65 years old.
effect of the high impact exercise on bone density in prepuberal girls

Conditions: Bone Loss, Age-Related,

Summary: osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is a major contributing factor associated with insufficiency fracture of the spine, wrist and proximal femur, and as a result, can diminish quality of life as well as increase direct and indirect healthcare costs. the pathophysiology of osteoporosis is based on two main factors; low bone mass and age associated architectural changes within the bone, high impact exercise in childhood can improve the peak bone mass and bone architecture. the evidence suggests that bone adaptation to increased load is optimal in early puberty (tanner stages i and ii) since around 30% of total body adult bone mass is accrued during this period. however, the optimal exercise program for increasing peak bone mineral content is still unclear. therefore, the aim of this study is to assess if 15 minutes of high-impact exercise three times per week improve areal bone mineral density assessed by dxa of pre pubertal girls after a ten-month regimen compared to low-impact exercise. this information could highly impact the development of public health policies directed to pre pubertal girls.


Eligibility criteria:
inclusion criteria: * girls between ages 8 to 10 * tanner i exclusion criteria: * precocious menarche (within the selected timeframe) * chronic disorders or medications known to affect bone metabolism or musculoskeletal function. * body mass index 30 or higher * regular vigorous physical activity (training more than 8 hours per week)

Keywords: bone mineral density isometric exercise bone growth
safety and feasibility of the xflo expander system (mercury)

Conditions: Benign Prostatic Hyperplasia

Summary: to demonstrate the safety and feasibility of the mercury expander system and procedure to treat patients with lower urinary tract symptoms (luts) secondary to urinary outflow obstruction from benign prostatic hyperplasia.

a prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the mercury expander system in patients with lower urinary tract symptoms (luts) secondary to urinary outflow obstruction from benign prostatic hyperplasia (bph).

Eligibility criteria:
inclusion criteria: * male gender * age ≥ 50 years * prostate volume 30 - 80 cc by abdominal ultrasound (aus) or trans rectal ultrasound (trus) * prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound). * medication history * not on bph related medication for the past 6 months. * if on bph related medication: * on 5-alpha-reductase inhibitors (aris), the patient must be on the medication for at least 3 months with a stable voiding pattern * on alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern * patients with symptomatic bph and related lower urinary tract symptoms (luts): * with international prostate symptom score (ipss) \> 13; qmax \< 12 ml/sec on a voided volume ≥125 ml; post-void residual (pvr) \< 250 ml; qol score ≥ 3 exclusion criteria: * previous bph procedure * median prostatic lobe or high bladder neck * urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations * elevated prostate specific antigen (psa) ≥ 10 ng/ml unless negative biopsy within last 6 months, or a positive biopsy showing cancer * cystolithiasis within the prior 3 months * history of neurogenic bladder or urinary retention with pvr \>1000ml. * serum creatinine \>1.8 mg/dl or upper-tract disease which compromises renal function * current or recent urinary tract infection (uti) or disease * known allergy to nickel * life expectancy of less than 24 months * known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure) * anticipated need for additional surgery or treatments for comorbidities during the study period. * current gross hematuria * other co-morbidities that could impact the study results * unable or unwilling to complete all required questionnaires and follow-up assessments * unable or unwilling to sign informed consent form * currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
reliability and validity of the kinesthetic and visual imagery questionnaire in acute stroke patients

Conditions: Image, Body; Acute Stroke

Summary: this study was planned to investigate the validity and reliability of the kinesthetic and visual imagery questionnaire in patients with acute stroke. the objectives of the research are: 1. to evaluate the validity of the kinesthetic and visual imaginery questionnaire in acute stroke patients aged 50-75 years 2. to evaluate the test-retest reliability of the kinesthetic and visual imaginery questionnaire in acute stroke patients aged 50-75 years

motor imagery (mi) is the mental representation of movement without any real body movement. mi is a complex and cognitive process involving the use of sensory and perceptual memories related to motor movements.various studies using brain imaging techniques have found that during motor imagery, brain areas similar to voluntary movement are activated or the motor cortex can be stimulated. these findings suggest that stroke patients who cannot physically move their limbs can stimulate brain regions responsible for motor movements using motor imagery. the kinesthetic and visual imaginery questionnaire (kviq) is a motor imagery questionnaire developed for people who need to be guided for different reasons and cannot perform complex movements. evaluate both visual and kinesthetic dimensions of motor images. this study was planned because of the need for evaluation of motor imagery for stroke patients, who mostly have motor and sensory problems.

Eligibility criteria:
inclusion criteria: * first stroke and ischemic stroke * being in the 50-75 age range * at least 24 hours after stroke * absence of apraxia and aphasia * get at least 15 points on the glasgow coma scale * score of 24 or more from mini mental test * stable vital signs and no improvement in symptoms for 48 hours * no signs of depression (score 15 or less from the beck depression scale) * sitting without support for 1 minute * not participating in another concurrent study * agree to participate in the study exclusion criteria: * other known neurological diseases * neglect of the body half * presence of cerebellum or mesencephalon lesion * drug use affecting cognition * patients with epilepsy, seizure attacks * those with severe heart and lung disease that may interfere with the study * patients with visual or auditory disabilities that might interfere with the study
occupational therapy and horticulture for cancer survivors with chronic pain

Conditions: Cancer Survivor; Chronic Pain

Summary: the purpose of this quasi-experimental study is to explore the impact of a therapeutic horticulture program as an occupation-based intervention to address chronic pain symptoms for cancer survivors. the main objectives are to assess participants' perceptions of pain, physical and psychosocial wellness, stress management, and quality of life at pre-, post-, and 3-month follow-up. quantitative and qualitative data will be synthesized and analyzed to explore this phenomenon.


Eligibility criteria:
inclusion criteria: * 18 - 64 years of age * history of cancer diagnosis * chronic pain longer than 3 months * have interest in therapeutic horticulture and exercise * able to participate in a moderate physical activity in sitting and/or standing for at least one hour twice a week * able to provide own transportation to the horticulture site or the supervised exercise program * able to comprehend, speak and write in english exclusion criteria: * uncontrolled seizure disorder * pregnancy