Kornimate/medical-research-clean huggingface dataset:
effects of melatonin on sleep, ventilatory control and cognition at altitude.

Conditions: Altitude Hypoxia; Ventilation; Sleep; Oxidative Stress; Neurocognitive Dysfunction

Summary: low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. central sleep apnea causes repeated awakenings and poor sleep. low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. reduced mental function due to low oxygen can pose a serious danger to mountain climbers. however there is also mounting evidence that even in populations of people that live at high altitudes and are considered adapted, low oxygen contributes to reductions in learning and memory. therefore there is a serious need for treatments which may improve sleep, control of breathing and mental function during low oxygen. melatonin is a hormone produced in the brain during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory properties. a study previously reported that melatonin taken 90 mins before bed at 4,300 m (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the following day. however how melatonin caused these effects was not determined. therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * sleep disorders * pregnant females * smokers (quit ≥ 1 year ago acceptable) * any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes. * prior or current use of melatonin. * use of any medications that may affect sleep or breathing, blood-thinning medications (anticoagulants), antioxidants, anti-inflammatories, medications that suppress the immune system (immunosuppressants), diabetes medications and birth control pills. * a psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders. * substantial alcohol (\>3oz/day) or use of illicit drugs. * previous occurrence of high altitude pulmonary or cerebral edema. * recent exposure to altitude (\>8000ft) in the last month or having slept at an altitude \>6000ft in the last month. * inability to provide written informed consent or able to complete the experiment. * non-english speakers (necessary to complete neurocognitive testing). * more than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.

Keywords: melatonin altitude sleep ventilation cognition
the effect of intraoperative magnesium sulfate infusion on the occurrence of emergence agitation

Conditions: Agitation,Psychomotor

Summary: this study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery

emergence agitation (ea) is a frequent postoperative complication in pediatric patients after general anesthesia. there are several suggested causes of ea and pain has been considered one of them. magnesium is an n-methyl-d-aspartate (nmda) receptor antagonist and increasingly used as an analgesic-adjuvant. we evaluate the pediatric anesthesia emergence delirium (paed) scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of ea in pediatric patients who undergo ophthalmic outpatient surgery.

Eligibility criteria:
inclusion criteria: * pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years exclusion criteria: * asa class ≥ iii * imbalance of electrolyte * myocardial damage or conduction abnormality on ecg * myasthenia gravis or any other neuromuscular disease * impaired renal function * denial to participate in study or not be able to give informed consent
sedentary behavior interrupted: a trial of acute effects on biomarkers of healthy aging

Conditions: Sedentary Lifestyle

Summary: this protocol "sedentary behavior interrupted: a randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (project 1)" is part of a national institutes of aging program grant called "sedentary time \& aging mortality and physical function (star). the overall purpose of the star program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. this protocol (also referred to project 1 of the star program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.

the specific aims of this protocol include: aim 1. to investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting. aim 2. to investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting. aim 3. to explore the moderating effect of age.

Eligibility criteria:
inclusion criteria: * female * 55 years of age and above * any ethnicity or race * screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day \& engage in less than 20 minutes of moderate-to-vigorous physical activity (mvpa) per day * bmi 25 - 45 kg/m2 * ambulatory * medically stable without any health conditions that would inhibit standing or pa; * able to give informed consent \& comply with study protocols; * able to read, communicate, and write fluently in english; * able to travel to study visits; * no menstruation for at least one year; * not participating or not planning to participate in a physical activity or weight loss program or research study. exclusion criteria: * mental state that would preclude complete understanding of the protocol or compliance; * type 1 diabetes; * type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants); * poorly controlled hypertension (systolic blood pressure ≥165 or diastolic blood pressure ≥100); * chronic illness that may be associated with weight change (hiv/aids, active cancer, or uncontrolled thyroid disease), * anemia (hemoglobin ≤11g/dl); * personal or first-degree relative history of venous thrombosis; * weight instability in past 3 months (no more than 5% up or down); * regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (\>2x) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke; * regular use of immunosuppressant or corticosteroid medication; * blood donation less than 56 days prior to screening visit, * smoking cigarettes or smoking or ingesting anything, and other use of tobacco products including e-cigarettes. * diagnosis of orthostatic hypotension
inflammatory response to opioid versus opioid free anesthesia

Conditions: Morbid Obesity; Opioid Use; Fentanyl Adverse Reaction; Cytokine Storm

Summary: anesthetic agents, including opioids can modulate the altered immune function in patients with obesity through mechanisms that involve the expression and release of cytokines. for this reason, anesthetic care in patients with obesity remains controversial. therefore, the aim of the study was to compare the effect of opioid-containing anesthesia vs opioid-free anesthesia using the cortínez-sepúlveda model on serum levels of il-6, il-1β and tnf-α before and after surgery in obese patients undergoing bypass surgery. methods: a randomized cross-sectional study of 40 unrelated obese adults was performed in the anesthesiology and bariatric surgery service at the civil hospital of guadalajara "dr. juan i. menchaca". before undergoing laparoscopic roux-en-y gastric bypass, patients were randomly assigned to two anesthesia groups: opiod-containing (n=20) or opioid-free (n=20). the opioid used in the opioid-containing anesthesia group was fentanyl. to characterize the disposition of intravenous propofol for the target-controlled infusion technique in obese patients, the cortínez-sepúlveda pharmacokinetic model was used. body mass was determined to the nearest 0.05kg using a balance scale (seca 703; seca, hamburg, germany). blood samples were taken before and immediately after surgery and cytokine serum levels were determined with elisa kits. statistical analyses were performed using the ibm statistical package for the social sciences software package version 20.0 (ibm corp., armonk, ny, usa).


Eligibility criteria:
inclusion criteria: * who were scheduled for bypass surgery at the service of anesthesiology and bariatric surgery of the civil hospital of guadalajara "dr. juan i menchaca", jalisco, mexico, were recruited. exclusion criteria: * patients with a history of ischemic heart disease, history of drug abuse, and with any known allergy to any of the drugs used during anesthesia. elimination criteria were: patients who withdrew their consent or with insufficient and poor quality blood samples (coagulated) or other reasons that did not allow sample processing.

Keywords: morbid obesity gastric bypass opioid containing anesthesia opioid free anesthesia cytokines
role of adiponectin and endothelial progenitor cells in reperfusion injury in patients with acute myocardial infarction

Conditions: Myocardial Infarction; Reperfusion Injury

Summary: there is experimental evidence that low levels of adiponectin are associated with more reperfusion injury. in addition experimental studies have demonstrated that endothelial progenitor cells may have a favorable effect on remodeling, mainly through stimulation of neo-revascularisation. clinical data on these issues are lacking. this clinical project studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a population of 250 infarction patients treated with primary pci. if the role of these factors could be confirmed in this clinical setting, those factors might represent a new target for therapeutic interventions in ami patients.


Eligibility criteria:
inclusion criteria: * stemi treated with primary pci exclusion criteria: * ischemia time \>12h * use of immunosuppressive therapy * unsuccessful recanalisation * not-interpretable st-t segment

Keywords: myocardial infarction reperfusion injury adiponectin endothelial progenitor cells
pre-hospital administration of tranexamic acid for moderate and severe traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: this study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

traumatic brain injury (tbi) remains a significant public health concern with poor outcome and one of the unmet needs in medical care. tranexamic acid (txa) has been shown to reduce blood loss after elective surgery and improve outcomes after traumatic injury due to bleeding without obvious adverse events. in the crash-2 intracranial bleeding study, with the nested randomized trial design, the study showed that treatment with txa within 8 hours of injury was associated with a reduction in haemorrhage growth \[adjusted difference, -3.8 ml, 95% confidence interval (ci), -11.5 ml to 3.9 ml\], fewer focal ischaemic lesions \[adjusted odds ratio (or) 0.54, 95% ci 0.20 to 1.46\] and fewer death (adjusted or 0.49, 95% ci 0.22 to 1.06) for patients with tbi (glasgow coma score ≤ 14). the study also provided direction for future research of txa in tbi, especially for the patients with moderate and severe tbi in whom an intracranial intracranial bleed (defined as the presence of parenchymal, subdural or epidural haemorrhage) is common. furtherly, results of the crash-2 trial stressed the importance of early adminstration with txa for trauma patients, with the evidence showing that treatment of txa within 1 hour post injury could significantly reduce the risk of death, while the benefit did not exist when txa was administered more than 3 hours after injury. if the use of txa could be incorporated into the pre-hospital management of tbi, the outcome of traumatically injured patients would be improved in an early stage. thus, our study sets out to employ a randomized controlled study design, with a sample of 400 patients, to evaluate the efficacy and safety of early use of txa in the pre-hospital management for moderate and severe tbi.

Eligibility criteria:
inclusion criteria: * moderate to severe injuries(post-resuscitation scores glasgow coma score of 4-12) * age \>= 18 year * non-penetrating tbi in 2 hours onset exclusion criteria: * patients with coagulopathy * pregnancy * receiving any medication which affects haemostasis * no consenting form

Keywords: traumatic brain injury
evaluation after reconstruction of the anterior cruciate ligament of the knee using the bioresorbable interference screw (sms): resorbability, per- and post-operative complications and articular functional recovery.

Conditions: Anterior Cruciate Ligament Rupture

Summary: the investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient is at least 18 years old * the patient is available for at least 3 years of follow-up * the patient requires ligamentoplasty pour rupture of anterior cruciate ligament confirmed by mri with or without meniscal lesions as scheduled surgery exclusion criteria: * the subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * the patient is pregnant or breast-feeding * the patient has a contra-indication (or a medically-incompatible association) for the treatment, including mri * revision surgery * simultaneous surgery
a placebo-controlled, randomized clinical trial to assess the safety, feasibility, and pharmacokinetics of microbiota transplant therapy with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (mtt) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (pah). this trial will inform development of future trials of mtt as a treatment for pah. 24 pah patients will be randomized to receive either mtt with antibiotic preconditioning + fiber supplementation, mtt with antibiotic preconditioning + placebo supplementation, or placebo + placebo supplementation. mtt will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. fiber supplementation will be 10-14 gm oral fiber supplement. patients will be followed at week 1, week 2, week 4, week 12, and week 24. patient will undergo stool sample collection at baseline, week 1, week 4, and week 12, blood sample collection at baseline, week 4, and week,12. in addition, patient will undergo an echocardiogram, six-minute walk test (6mwt) and quality of life questionnaire at baseline and at week 12.


Eligibility criteria:
inclusion criteria: * provision of signed and dated consent form * ages 18-75 * diagnosis of pah * on stable treatment for pah for one month prior to enrollment * able to swallow capsules * able to provide blood sample and fecal sample * stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence. exclusion criteria: * dysphagia to pills * clinically active inflammatory bowel disease * pregnancy or breastfeeding. a pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of mtt). patients with a positive pregnancy test will be excluded. a negative result will be required for subjects who are females of child-bearing potential to receive mtt. patients will be counseled to avoid pregnancy which is the standard of care for patients with pah. * life expectancy of \< 6 months * presence of ileostomy or colostomy * patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, jak inhibitors). * patients with neutropenia (an absolute neutrophil count \< 0.5 x 10 9 cells/l) obtained on a complete blood count with differential at screening * history of solid organ or bone marrow transplant * anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis) * history of severe anaphylactic food allergy * history of celiac disease * patients receiving cancer chemotherapy, immunotherapy, or radiation
helicobacter pylori 23s rrna/gyra gene mutation detection kit (fluorescence pcr fusion curve method)

Conditions: Helicobacter Pylori Infection; Helicobacter Pylori gyrA Levofloxacin Resistance Mutation; Fecal Drug Resistance Gene Detection; Helicobacter Pylori Infection, Susceptibility to

Summary: the purpose of this study was to evaluate the detection ability of helicobacter pylori 23s rrna/gyra gene mutation detection kit (fluorescent pcr fusion curve method) for helicobacter pylori gene mutation.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.

Eligibility criteria:
inclusion criteria: * 1. patients with helicobacter pylori infection who need gastroscopy; 2. patients with positive helicobacter pylori culture in gastric mucosa 3. helicobacter pylori negative patients exclusion criteria: * 1.patients with insufficient fecal samples collected 2.patients with contraindication of gastroscopic biopsy

Keywords: fecal gene detection levofloxacin resistance gene clarithromycin resistance gene
efficacy of lazolex® gel in the treatment of herpes simplex

Conditions: HSV Infection

Summary: study aimed to evaluate the efficacy and tolerance of lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.

a single-center, single-arm, open-label, phase ii clinical trial was conducted with 30 patients divided into two groups: 15 patients with herpes simplex virus type 1 (hsv-1) infections and 15 with herpes simplex virus type 2 (hsv-2) infections. all received topical treatment with lazolex® gel four times daily for 10 days. the efficacy and tolerance of the treatment were evaluated on day 10 and day 20 after the study started. in addition, recurrence rates were evaluated before treatment with lazolex® and after a 4-year follow-up period after treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of acute or chronic herpes simplex mucocutaneous infection, * mild course of disease (defined as body temperature \<37.2°c and without signs of general infirmity), * application of last treatment for herpes simplex infection \>3 months, * available to cooperate during the study, * provision of written informed consent. exclusion criteria: * abnormal laboratory results, * hypersensitivity to the product or its components, * pregnancy or breastfeeding, * acute/ chronic renal or liver failure, * history of migraine, * organic brain lesion, * generalized anxiety disorder, * blood supply disturbance in the vertebrobasilar pool, * stage 3 essential hypertension, * concomitant acute or decompensated disease that could affect the study results, * intake of acyclovir, antibiotics, immunosuppressants, antimetabolites, or glucocorticosteroids during 3-month period prior to the study, * concomitant participation in another clinical trial.
dupilumab and milk oit for the treatment of cow's milk allergy

Conditions: Allergies Food Milk

Summary: this is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in approximately 40 subjects aged 4 to 50 years, inclusive, who are allergic to cow's milk. the primary objective is to assess whether dupilumab as an adjunct to milk oral immunotherapy (oit) compared to placebo improves the safety of milk oit and rates of desensitization, defined as an increase in the proportion of subjects who pass a double-blind placebo-controlled food challenge (dbpcfc) to at least 2040 mg cumulative milk protein at week 18.


Eligibility criteria:
inclusion criteria: * age 4 to 50 years (inclusive) * clinical history of allergy to cow's milk or milk-containing foods * serum ige to milk of \>4 kua/l within the last 12 months and/or a spt to milk ≥6 mm compared to a negative control * experience clinical reaction at or before 444 mg cumulative protein dose of cow's milk protein on screening dbpcfc * no clinical reaction observed during the placebo (oat) screening dbpcfc * subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study * use of effective birth control by female participants of childbearing potential exclusion criteria: * any previous exposure to dupilumab * known hypersensitivity to dupilumab or any of its excipients * known hypersensitivity to epinephrine or any of its excipients * allergy to oat (placebo in dbpcfc) * history of severe anaphylaxis to cow's milk, defined as neurological compromise or requiring intubation * recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year * inability to tolerate biological (antibody) therapies * body weight \<5 kg at the time of screening * history of eosinophilic esophagitis (eoe), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (gerd), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology * history of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * history of a mast cell disorder * established diagnosis of a primary immunodeficiency disorder * severe asthma or mild or moderate asthma if uncontrolled or difficult to control * current participation or within the last 4 months in any other interventional study * use of medication such as beta-blockers (oral), angiotensin-converting enzyme (ace) inhibitors, angiotensin-receptor blockers (arb) or calcium channel blockers * pregnant or breastfeeding women

Keywords: food allergy milk allergy oral immunotherapy