Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of medi5884 in adults with stable coronary heart disease

Conditions: Stable Coronary Heart Disease

Summary: a study to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of medi5884 in adults with stable coronary heart disease.

a randomized, double-blind, placebo-controlled, parallel-designed study to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of medi5884 in participants with stable coronary heart disease.

Eligibility criteria:
inclusion criteria: * diagnosis of stable coronary heart disease prior to screening * currently receiving high intensity statin(s) exclusion criteria: * unstable cardiovascular conditions * any planned arterial revascularizations * fasting laboratory values at screening: triglycerides \> 500 mg/dl, low density lipoprotein-cholesterol \> 100 mg/dl * any disease or condition or laboratory value that would place the participant at an unacceptable risk.

Keywords: coronary heart disease pharmacokinetic pharmacodynamics
the left atrial appendage closure by surgery and the incidence of stroke in patients undergoing open-heart surgery.

Conditions: Left Atrial Appendage Thrombosis

Summary: this study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative af status and stroke risk.

cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. the etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state. most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. the high incidence of postoperative af in these patients suggests a possible embolic cause for some strokes. as such, some postoperative strokes may be preventable. previous studies report incident af in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (cabg) and valve surgery. in patients with non-operative af, the risk of ischemic stroke is markedly reduced by adequate oac. however, the management of postoperative af is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. the risk of bleeding poses a significant limitation to the use of oac, which consequently increases focus on left atrial appendage (laa) closure, as the laa is a predilection site for thrombus formation during af. based on previous studies, ≥90% of af-related left atrial thrombi are located in the left atrial appendage (laa), and therefore, laa occlusion is a tempting method for af-related stroke prevention. current recommendations regarding surgical left atrial appendage (laa) closure to prevent thromboembolisms lack high-level evidence.

Eligibility criteria:
inclusion criteria: * ≥18 years scheduled for first-time planned open-heart surgery. exclusion criteria: pediatric population \>18 years. emergent open heart surgery. patients with current endocarditis. where follow-up is not possible. the patient refused to sign the informed consent to participate in the research.

Keywords: surgical closure of the left atrial appendage. stroke post operative atrial fibrillation.
east-west collaborative medicine using bee-venom acupuncture on whiplash-associated disorders

Conditions: Whiplash Injuries

Summary: 1. purpose of study 1. to evaluate the efficacy of east-west collaborative medicine using bee-venom acupuncture therapy on whiplash-associated disorders using vas scale 2. to evaluate the efficacy of east-west collaborative medicine using bee-venom acupuncture therapy on whiplash-associated disorders using ndi, bdi, sf-36, and eq-5d. 2. interventions \& groups 1. group 1: bee-venom acupuncture therapy 2. group 2: zaltoprofen 3. group 3: bee-venom acupuncture therapy \& zaltoprofen


Eligibility criteria:
inclusion criteria: * clinical diagnosis of whiplash injuries * must have cervicalgia of more than vas 5 exclusion criteria: * cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection * spinal operation * other musculoskeletal pain * physicological or mental disorders

Keywords: bee venom acupuncture east west collaborative medicine whiplash associated disorder
sleep quantity and quality in the icu: a prospective observational stud

Conditions: Sleep Disturbance; Critical Illness

Summary: several evidences in the literature suggest sleep interruption in critical care patients. nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown. in this study, the amount of time spent by the patients in n1, n2 n3 and rem phases during sleep is quantified.


Eligibility criteria:
inclusion criteria: * age \> 18 years exclusion criteria: * pregnancy * previous enrollment in the same study (sleep recording during previous night) * previous use of hypnotic drugs

Keywords: intensive care unit sleep interruption sleep phases
gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke

Conditions: Ischemic Stroke

Summary: post-stroke cognitive impairment(psci) is one of the most important factors causing disabilities after stroke. recent study found that gut microbiota plays a key role in neurological diseases. two recent small sample studies reported gut dysbiosis in psci patients. in order to further verify the relationship between psci and gut microbiota and the predictive value of gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke. the study intended to collect stool specimens of patients with acute ischemic stroke and assess their cognitive psychological state, and to establish a prospective multi-center follow-up cohort to explore the correlation between the dynamic changes of intestinal flora in patients with stroke and psci and poor prognosis of stroke.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for acute ischemic stroke; * aged between 18-75; * onset within 7 days; * sign informed consent and agree to provide relevant medical history data and biological specimens. exclusion criteria: * patients diagnosed with tia * severe disturbance of consciousness (nihss consciousness score \> 1) * previous severe mental disorders and dementia (ad8 score ≥ 2) * history of cerebral hemorrhage or any stroke within 12 months; * serious systemic diseases including malignant tumors * patients with aphasia and unable to cooperate to complete the montreal cognitive assessment (moca) * alt or ast greater than 2 times the upper limit of normal value or severe liver disease; * gfr less than 30ml/min/1.72m2 or severe kidney disease * alcohol abused, drug use and chemical poisoning history (such as pesticide poisoning) * patients with previous history of gastrointestinal tract or confirmed during hospitalization * patients who could not collect stool samples within 4 days after admission.

Keywords: ischemic stroke; cognitive impairment; gut microbiota
paracetamol on postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (ponv) which is a common problem. this prospective randomized study aimed to compare the efficacy of paracetamol on ponv in adults undergoing maxillofacial surgery.

one hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the iv infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the iv infusion of saline (1.5 mg/kg). the presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as ponv. all ponv episodes and postoperative pain scores are recorded during 24h postoperatively. the postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.

Eligibility criteria:
inclusion criteria: * asa (the classification of the american society of anesthesiologists) physical status i-ii * patients who scheduled for elective maxillofacial surgery under general anesthesia exclusion criteria: * patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol) * history of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases * use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery

Keywords: ponv paracetamol
myfitnesspal pilot study

Conditions: Weight Reduction

Summary: this project is studying whether patients who use myfitnesspal as an aid to weight loss have more success than patients who are only given traditional medical guidance from the patient's physician.

patients will be given a survey determining the patient's eligibility to be part of the study. based on the results patients will be consented and then randomized into two arms. the intervention group will download myfitnesspal onto the patient's smartphone and given guidance on how to use the application in order to help with weight loss. the control group will receive traditional weight loss counseling from the physician. both groups will have measurement recorded for weight, blood pressure, and waist circumference at the patient's initial visit. all patients will be asked to return to the clinic at no cost to the patient to have measurements recorded for the patient's weight, blood pressure, and waist circumference at 1 month, 3 months, and 6 months after the patient's initial visit. at the conclusion of the study, patients who were in the intervention group will be asked to take a final survey regarding the patient's use of the myfitnesspal application.

Eligibility criteria:
inclusion criteria: * bmi\>/= 25 * have a smart phone * patient is willing to lose weight exclusion criteria: * do not have a smart phone * pregnant (current, planned, or previous pregnancy within 6 months) * have already seen a nutritionist * on weight loss medication * using outside weight loss programs * lack interest in weight loss * hemodialysis patient * has a life expectancy less than 6 months
chd risk, behavioral stress and reproductive hormones

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Menopause

Summary: to determine the effects of behavioral stress and reproductive hormones on coronary heart disease (chd) risk.

design narrative: the behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in chd. the ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status. building on these findings, but also departing from previous efforts in strategy and design, five studies are conducted. study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge. using longitudinal designs, study 2 compares women's stress responses prior to and three months after surgical menopause, whereas study 3 compares healthy women's stress responses prior to and three months after a "temporary menopause" due to the administration of a gnrh agonist. in both studies, some women after the second testing are administered estrogen replacement therapy and stress responses are again measured. thus, studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses. these studies gain significance from the fact that surgical menopause is associated with heightened risk for chd, whereas estrogen replacement therapy is associated with protection from chd. study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class. social class is included in the design because it is a risk factor for psychological stress and for chd. the final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a study to assess the efficacy and safety of etc-1002 in subjects with elevated blood cholesterol and either normal or elevated triglycerides

Conditions: Dyslipidemia

Summary: this phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of etc-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.


Eligibility criteria:
major inclusion criteria: * provision of written informed consent prior to any study-specific procedure * fasting ldl-c between 130 and 220 mg/dl following wash-out of all lipid regulating medications and supplements * fasting triglyceride \<400 mg/dl following wash-out of all lipid regulating medications and supplements * bmi between 18 and 35 mg/kg2 major exclusion criteria: * clinically significant cardiovascular disease, diabetes or uncontrolled hypertension * females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
volar locking plate versus external fixation for distal radius fracture - a longterm follow up

Conditions: Radius Fracture Distal; Surgery; Surgery--Complications; Treatment Complication; Tendon Injuries; Tendon Rupture; Surgical Site Infection; CRPS Type I; CRPS Type II; Dislocation; Osteoarthritis

Summary: a 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.

follow up includes proms (dash, prwe, eq-5d), radiological assesment and objective tests by a hand occupational therapist (rom, grip strength). previous clinical trials registration for the original studies this long-term follow up is a continuation on: nct00989222, nct01034943, nct01035359

Eligibility criteria:
inclusion criteria: ds center * acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees. * age 20-70 sös center * age 50-74 for women and 60-74 for men * injury only after fall from a standing height * wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening * good knowledge of written and spoken swedish * fracture diagnosed within 72 hours from injury * patient resident within the catchment area of sös center exclusion criteria: ds center: * no previous fracture of either wrist * ipsilateral acute fracture of the upper extremity * medicated with warfarin * unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems) * open fracture * fracture that was not amenable by both methods (distal fragment to small or to comminuted) sös center: * former disability of either wrist * other concomitant injuries * rheumatoid arthritis or other severe joint disorder * dementia or pfeiffer score under 5 points * drug abuse, alcohol abuse or psychiatric disorder * dependency in activity of daily living * medical condition contradicting general anesthesia
a pilot rct: the impact of a virtual mbsr course on women with primary infertility

Conditions: Primary Infertility; Mental Health Issue; Quality of Life

Summary: we plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual mindfulness-based stress reduction (mbsr) program. primary outcomes included retention and survey completion rates. secondary outcomes included beck depression inventory (bdi), beck anxiety inventory (bai), perceived stress score (pss), fertility problem index (fpi), pregnancy rates, intention to pursue treatment and % pursuing treatment.


Eligibility criteria:
inclusion criteria: -primary infertility and no prior fertility treatment exclusion criteria: * no internet access * non-english speaking * history of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, ptsd * psychotropic medication change in the previous month * previously seen at another fertility clinic * previous mbsr course * previous mindfulness meditation retreat
assessment of accuracy and safety of labtest checker

Conditions: Abnormalities in the Blood Test Results

Summary: the goal of this study is to assess performance of a new clinical decision support system named labtest checker in a cohort of adult patients reporting to the internal ward's emergency department. the main question it aims to answer is: • how accurate and safe is labtest checker. a set of blood laboratory tests will be ordered for each participant. participants will use labtest checker to obtain an interpretation of their test results. the interpretation provided by labtest checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.


Eligibility criteria:
inclusion criteria: * adult * requires laboratory test investigation exclusion criteria: * under 18 years old * pregnant * no need for laboratory test investigation

Keywords: laboratory test interpretation artificial intelligence clinical decision support system clinical implementation
comparative study between russian and exercise in subjects with flexible flatfoot

Conditions: Flat Feet

Summary: the prevalence of flexible flat foot was 13.6% in adults a cross-sectional study (for males-12.8%; for females-14.4%).18-21-year-old indian adults. this trial aims to compare between the effects of russian current for tibialis posterior muscle and comprehensive exercise alone in subjects suffering from flexible flat foot on quality of life, rom, strength of tibialis posterior and foot posture


Eligibility criteria:
inclusion criteria: * the patient's age ranges from 20 to 25 years. * both genders. * patients suffering from symptomatic flat foot exclusion criteria: * rigid flatfoot. * pregnancy and lactation. * recent fracture and fixation. * genu valgus. * cardiac pacemaker. * inflammatory disorders / rheumatoid arthritis.
effect of intraoperative dexmedetomidine on development of acute kidney injury

Conditions: Malignant Tumor

Summary: to investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

a cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. it may also enhance a renal perfusion by inhibition of renal sympathoexcitation. we hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Eligibility criteria:
inclusion criteria: * diagnosis of malignant tumor with peritoneal metastasis * scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy exclusion criteria: * preoperative chronic kidney disease stage ≥4 defined by kdoqi ( egfr \< 30 ml/min/1.73m2) * congestive heart failure * atrioventricular block \> 1st degree * bradycardia \< 45 beat per minute * history of myocardial infarction within 3 months * pregnancy
clinical values of voiding diary for diagnosis and treatment for monosymptomatic enuresis in children

Conditions: Nocturnal Enuresis

Summary: nocturnal enuresis is common problem in children who are from 5 to 18 years old and do not spontaneously urinate at least 2 times a week for more than 3 months. it can lead to major distress for the children and their parents. the investigators hypothesize that the 3-day voiding diary as the same as the 7-day voiding diary could be a diagnostic tool to provide information on the diagnosis and classification of nocturnal enuresis. the purpose of this study is to investigate the reliability and sensitivity of 3-day versus 7-day voiding diary to diagnose nocturnal enuresis.

during the first visit to a doctor, a questionnaire about nocturnal enuresis will be filled in and additional tests will be done according to the standard procedure to screen out who have monosymptomatic enuresis.then participants will complete a 3-day voiding diary or a 7-day voiding diary before treatment. during the second visit to a doctor, doctors will diagnose by voiding diary which type of enuresis is present. participants need to fill in the 3-day or 7-day voiding diary at 1, 3 and 6 months after standard treatment. about 800 patients from 5 to 18 years old will be included in this prospective, randomized, controlled, multi-center and large sample study and will be followed up at the outpatient clinic.

Eligibility criteria:
inclusion criteria: * children are from 5 to 18 years old and do not spontaneously urinate at least 2 times a week for more than 3 months. * monosymptomatic enuresis (mne): children are only associated with nocturnal enuresis, not with daytime lower urinary tract symptoms. exclusion criteria: * non-monosymptomatic enuresis (nmne):children have day-time symptoms, such as overactive bladder, discoordinated micturition, dysuria, infrequent voiding and so on. * children have psychiatric disorder, urinary tract infection, malformations of the urethra, kidney disease and so on. 3.children have been previously treated for nocturnal enuresis who use drugs or other therapeutic regimen. 4.secondary enuresis: after 6 months of non-enuresis period, children wet the bed again.

Keywords: nocturnal enuresis voiding diary
safety and equivalence of a terconazole vaginal suppository (test product) compared to the reference terconazole vaginal suppository in the treatment of vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: the objectives of this study were to demonstrate comparable safety and efficacy of terconazole vaginal suppositories, 80 mg(test product) and terconazole vaginal suppositories, 80 mg(reference product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.


Eligibility criteria:
inclusion criteria: * female at least 18 years of age * presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis * willing and able to read and sign an irb approved icf, which included agreement to comply with all study requirements as indicated in the protocol. exclusion criteria: * history of hypersensitivity or allergy to imidazoles * female who was pregnant or lactating * was menstruating or expected the onset of menses during the treatment days * had evidence of any bacterial, viral or protozoal infection * had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study * had any condition or used any medication that, in the opinion of the investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk * had participated in any investigational study within 30 days prior to study enrollment

Keywords: vulvovaginal candidiasis terconazole