Kornimate/medical-research-clean huggingface dataset:
remimazolam reduces emergence delirium in preschool children undergoing laparoscopic surgery by sevoflurane anesthesia

Conditions: Emergence Delirium

Summary: emergence delirium (ed) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. the incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. the use of sevoflurane has been identified as one of the most important risk factors. in the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ed.

one hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. anesthesia is induced with propofol，fentanyl and rocuronium. in group p (placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. then intravenous bolus of 0.2ml/kg normal saline is administered. in group b (bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. then intravenous bolus of 0.2mg/kg remimazolam is administered. in group c (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. then intravenous bolus of 0.2ml/kg normal saline is administered. maintain bis values in the range of 40-60. recorded the pediatric anesthesia emergence delirium scale (paed) during the recovery period.

Eligibility criteria:
inclusion criteria: 1. -with american society of anesthesiologists (asa) physical status i or ii； 2. -aged 1-6 years； 3. -children with weight for age within the normal range； 4. -were scheduled laparoscopic surgery by sevoflurane anesthesia. exclusion criteria: 1. -children who had abnormal liver and kidney function,cardiovascular or endocrine dysfunction; 2. -allergy or hypersensitive reaction to remimazolam; 3. -with any organ dysfunction; 4. -recently respiratory infection, mental disorder; 5. -other reasons that researchers hold it is not appropriate to participate in this trial.

Keywords: remimazolam emergence delirium
the short term effect of hot packs and whirlpool for increasing total active motion at the wrist

Conditions: Distal Radius Fracture

Summary: this study investigates the effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (drf). patients with recently healed drf are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits. the effect of these modalities on range of motion and volume of the hand are evaluated, with measurements taking place before and immediately after heat during each visit.

this study investigates the short term effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (drf) during a therapy visit. patients with recently healed drf are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits. measurements of wrist and forearm range of motion, and volume of the hand are recorded before and immediately after heat for each visit, effectively creating six measurement time points. change scores are recorded for range of motion and for volume, and analyzed using manova to determine differences between groups.

Eligibility criteria:
inclusion criteria: * healed drf, * allowed to perform motion. exclusion criteria: * complex regional pain syndrome, * inability to read/understand english, * inability to attend follow up sessions due to driving distance from clinic, * raynaud's phenomenon
cicatrix in the treatment of hypertrophic scars and keloids scars

Conditions: Hypertrophic Scars; Keloids

Summary: the purpose of the study is to assess the efficacy of cicatrix (asian gotu kola or pennywort) usage in the treatment of hypertrophic scars and keloids. the duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. the estimated number of persons to be recruited and randomized for the study is 90.


Eligibility criteria:
inclusion criteria: * hypertrophic wound or keloid with no treatment for more than 1 month. * signed informed consent. exclusion criteria: * usage of steroids within 30 days. * malignant neoplastic conditions. * alcoholism. * handicap and/or psychiatric condition preventing treatment accomplishment.

Keywords: hypertrophic scars keloids asian gotu kola asian pennywort
safety and efficacy of vaniprevir (mk-7009) with pegylated interferon (peg-ifn) and ribavirin (rbv) in treatment-experienced hepatitis c virus (hcv) participants (mk-7009-009)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of vaniprevir + peg-ifn and ribavirin as compared to placebo (pbo) + peg-ifn/rbv. the primary hypotheses are that vaniprevir is well tolerated, and that vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (nc) participants achieving undetectable hcv ribonucleic acid (rna) 24 weeks after the end of study therapy (svr24).


Eligibility criteria:
inclusion criteria: * has chronic hcv genotype 1 infection * is treatment-experienced * for the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma. exclusion criteria: * has not tolerated previous course peg-ifn and rbv * is unlikely to tolerate at least 24 weeks of continuous therapy with peg-ifn and rbv * is co-infected with human immunodeficiency virus (hiv) and/or hepatitis b * consumes excessive amounts of alcohol * has a history of drug or alcohol abuse * if female, participant is pregnant or breastfeeding * has been in a clinical trail with an investigational drug in the last 30 days * has used ifn/peg-ifn and rbv in the last 3 months

Keywords: hepatitis c
a novel adaptive anastomotic technique for left-sided colonic and rectal resection

Conditions: Colorectal Neoplasms

Summary: the c-rex device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. this study aims to collect preliminary evidence on the effectiveness of c-rex a real-word setting.

despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. in most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. the device c-rex, developed by carponovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete healing. this may lead to reduced anastomotic leak rate and severity. this study aims to collect preliminary evidence on the effectiveness of c-rex to develop a future larger multicentric trial. the objective of the study is to provide preliminary data to determine whether the c-rex device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the c-rex device in a real-word setting.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old, men or women. * planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice. * patient indicated to elective minimally invasive sigmoid or high rectal resection. exclusion criteria: * patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. * patients with preoperative evidence of distal metastasis. * patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. * patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition. * patients indicated to defunctioning ileostomy (intention to treat). * any condition that, in the opinion of the investigator, may interfere with the study conduction. in particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of c-rex.

Keywords: colorectal neoplasm anastomosis surgical device
lymphatic function in patients with a fontan-kreutzer circulation

Conditions: Lymphatic Abnormalities; Lymphatic Edema; Univentricular Heart

Summary: the lymphatics regulate the interstitial fluid by removing excessive fluid. it represents an extremely important step in the prevention of edema. the fontan-kreutzer procedure has revolutionized the treatment of univentricular hearts. however, it is associated with severe complications such as protein-losing enteropathy (ple) and peripheral edema that may involve the lymphatic circulation. our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and ple. the functional state of lymphatics is investigated using near infrared fluorescence imaging, nirf. the anatomy is described using non-contrast mri and the capillary filtration rate is measured using plethysmography.

background: the lymphatics regulate the interstitial fluid by removing excessive fluid. it represents an extremely important step in the prevention of edema. the fontan-kreutzer procedure has revolutionized the treatment of univentricular hearts. however, it is associated with severe complications such as protein-losing enteropathy (ple) and peripheral edema that may involve the lymphatic circulation. hypothesis: patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and ple. material and methods: the functional state of lymphatics is investigated using near infrared fluorescence imaging, nirf. the anatomy is described using non-contrast mri and the capillary filtration rate is measured using plethysmography. the study population is patients with fontan-kreutzer circulation operated at aarhus university hospital. exclusion criteria is bmi\>30 and age (years) \< 18. the fontan-kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.

Eligibility criteria:
inclusion criteria: * fontan-kreutzer circulation exclusion criteria: * bmi\>30, * age\<18 * mental illness
study to assess safety and tolerability of eo2002

Conditions: Cataract; Endothelial Cell Loss, Corneal

Summary: the goal of this clinical study is to assess the safety of intracameral injection of eo2002 in subjects post-cataract surgery.


Eligibility criteria:
key inclusion criteria: 1. age ≥ 18 years. 2. subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery. 3. decreased endothelial cell count exclusion criteria: all ocular criteria apply to study eye unless otherwise noted. 1. other corneal disease 2. macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in bcva. 3. descemet membrane detachment. 4. history of uveitis or other ocular inflammatory disease. 5. history of incisional glaucoma surgery 6. prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. 7. history of ocular neoplasm. 8. etdrs bcva in the fellow eye is worse than 35 letters (snellen equivalent of 20/200). 9. female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study. 10. subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration. 11. any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.
1565nm non-ablative fractional laser treat alopecia areata

Conditions: Alopecia Areata

Summary: the goal of this clinical trial is to evaluate and explore the mechanism of 1565-nm non-ablative fractional laser in the treatment of alopecia areata. the main questions it aims to answer are: (a) comparing the secretion of various cells and cytokines around and within hair follicles before and after treatment; (b) determining the lord want effector cells with cytokines and demonstrating that they mediate involvement in correcting the immune immunity collapse process. participants' 1/2 of the treated alopecia area was compared to their own other half of the untreated alopecia area, and they were followed every three months for efficacy assessment and scalp biopsy.


Eligibility criteria:
inclusion criteria: * male or female subjects aged ≥ 18 years and ≤ 55 years of age; * alopecia areata subjects, and diagnosed with alopecia areata for 6 -12 months before screening; * women of childbearing age, non-pregnant or lactating, and subjects and their partners voluntarily take contraceptive measures deemed effective by the investigator during treatment and for at least 6 months after the last trial; * those who have no contraindications to the use of materials; * subject is able to understand and voluntarily sign the written informed consent form, which must be signed prior to the execution of any trial-specified study procedures; * subjects must be voluntary and able to complete the study procedure and follow-up examination. exclusion criteria: * subjects who meet the diagnostic criteria for alopecia areata but are accompanied by the following diseases cannot be enrolled: local infection (bacterial, fungal or viral) at the site requiring laser treatment; have a psychiatric disorder (e.g., schizophrenia, neurosis, organic psychosis, etc.); * subjects who have previously treated drugs or surgeries and cannot be enrolled in the following situations: receiving other anti-alopecia areata treatments (including topical glucocorticoids,microneedling, laser treatment, etc.) at the same time; receiving any other clinical investigational drug treatment concurrently; * any other situation or condition in which the investigator considers that the subject is not suitable to participate in this study.

Keywords: alopecia areata 1565nm non-ablative fractional laser immune privilege
affect of duavive on mood & anxiety symptoms

Conditions: Menopause; Depression, Anxiety; Sleep; Menopause Related Conditions

Summary: this study evaluates the impact of conjugated estrogens/ bazedoxifene (ce/ bza) on the mood (depression and anxiety) in peri- and early menopausal women.

during the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. fluctuation in estrogen levels appears to play a role in this. the investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (ce/ bza), may improve mood symptoms in this population. in 2017, ce/ bza was approved for menopausal vasomotor symptoms (vms) in canada, but the effect on mood were not examined closely. the investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. the participants will go through a round of treatment with ce/bza. the study will last 16 weeks. the study's objectives are to determine primarily if ce/bza improves mood among peri- and early postmenopausal women, and secondarily if treatment with ce/bza improves their sleep.

Eligibility criteria:
inclusion criteria: * females between 45-60 years of age * able to communicate in english * in perimenopause as defined by world health organization (who) stages of reproductive aging workshop (straw) criteria, or in early menopause (within 10 years of final menstrual period) * suffering from depressive symptoms (10+ on ces-d-10) and/or anxiety symptoms (10+ on gad-7) exclusion criteria: * personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia. * abnormal uterine bleeding that has not been adequately investigated. * active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease). * active liver disease. * known protein c, protein s, or antithrombin deficiency or other known thrombophilic disorders. * known or suspected pregnancy, women who may become pregnant, and nursing mothers * partial or complete loss of vision due to ophthalmic vascular disease. * uncontrolled hypertension (systolic blood pressure \>160mm hg and/ or diastolic blood pressure \>95 mm hg) * endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., cushing's disease, addison's disease). for women with abnormal tsh, it will be corrected in advance of trial initiation. * active serious suicidal ideation with intent. * symptoms of active psychosis. * daily use of antidepressive medication. * use of other psychoactive or centrally acting medications within 2 weeks before study screening. * known hypersensitivity to either ce or bza.

Keywords: hormone replacement therapy
a study to investigate the safety and effect of food on the pharmacokinetics of ym178 in healthy volunteers

Conditions: Healthy Volunteer; Pharmacokinetics of YM178

Summary: the purpose of the study is to evaluate safety of ym178 and the effect of food intake on the pharmacokinetics of ym178 in healthy adult subjects.

a open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of ym178 administered under fasted and fed conditions.

Eligibility criteria:
inclusion criteria: * a normal or clinically non-significant 12 lead ecg as well as normal or clinically non-significant laboratory test results at the time of screening * body weigh at least 50 kg in male and 45 kg in female and body mass index (bmi) between 18.5 and 26.9 kg/m2 * all women of child bearing potential are required to use adequate contraception consisting of two forms of birth control exclusion criteria: * hypersensitivity to ym178 or other beta-3 agonists or any of the constituents of the formulation used * liver function test values above the upper limit of normal * a history or presence of psychiatric illness, serious active or recurrent infection * a previous history of cancer other than basal cell carcinoma or stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study * donated or lost ≥ 500 ml blood within 3 months or donated plasma within 2 weeks prior to the study * receiving or being anticipated to receive a prescription drug or otc medications within 14 days prior to the study * consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or seville oranges (e.g., bitter marmalade) within 48 hours before the study * a history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study * currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days

Keywords: overactive bladder urinary incontinence ym178 mirabegron food effect
technological processes on quality of meat

Conditions: Sarcopenia

Summary: this project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. the hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and amino acids bioavailability for muscle synthesis.

beef meat, whose proteins were intrinsically labelled with 15 n, was previously obtained by infusing 15n ammonium sulphate during 50 days in the rumen of an heifer. two different cooking conditions have been applied to this meat (5 min at 55°c vs 30 min at 90°c). ten healthy elderly volunteers will test each processed meat according to a cross-over design, during 2 different metabolic studies separated by at least 2 weeks. volunteers will be submitted to a diet controlled for its protein content, for 4 days (1.2 g protein/kg/day) before each metabolic investigation. on the 2 days of metabolic investigations, after an overnight fast, blood samples will be collected for basal measurements. then the subjects will be perfused with l-\[1-13c\] leucine for 9h30 hours, during which expired gas and blood samples will be regularly taken, and co2 production measured. the volunteers will be asked to eat a 130 g beef meat 2.5h after the onset of the perfusion. isotopic enrichments in expired gas, in plasma alpha-cetoiscaproate and in free leucine will be measured to determine whole body amino acids fluxes (oxidation, protein synthesis and proteolysis). 15n enrichments of leucine will allow splanchnic extraction measurement.

Eligibility criteria:
inclusion criteria : * male * age \> 70 * body mass index 21 \< bmi \< 28 kg/m2 * affiliated to national health insurance * subject giving his written informed consent * subject considered as normal after clinical and medical examinations exclusion criteria : * positive serologies to hiv or hcv, or abnormal laboratory tests * previous medical and/or surgery judged by the investigator as incompatible with this study * person who doesn't eat beef or only if prepared according to religious rite * person wearing a removable denture or suffering of dry mouth syndrome * regular medication with glucocorticoids * intense sports activity \> 7h/week * heavy alcohol consumption * being under someone's supervision * refusal to be registered on the national volunteers data file * being in exclusion on the national volunteers data file

Keywords: meat processes amino acids bioavailability digestion rate protein synthesis aging sarcopenia