Kornimate/medical-research-clean huggingface dataset:
alk29-002: a study of baclofen formulations in healthy adults

Conditions: Alcohol Dependence

Summary: the purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 years * body mass index of 19 to 30 kg/m2 at screening * if subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study exclusion criteria: * pregnancy and/or currently breastfeeding * clinical significant medical condition or observed abnormalities * acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery * participation in a clinical trial within 30 days before screening * known intolerance and/or hypersensitivity to baclofen or its excipients * use of alcohol-, caffeine-, or xanthine-containing products * clinically significant illness within 30 days of first study drug administration * dietary restrictions that conflict with required study meals

Keywords: alk29 alcohol dependence pharmacokinetics
management of nailbed injuries

Conditions: Nail Bed Injury

Summary: the purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.


Eligibility criteria:
inclusion criteria: * any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present exclusion criteria: * nail plate absent over the nailbed injury
apatinib combined with sox neoadjuvant therapy for locally advanced gastric cancer

Conditions: Apatinib Combined; SOX; Neoadjuvant Therapy; Locally Advanced Gastric Cancer

Summary: we star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of apatinib combined with oxaliplatin, gimeracil and oteracil porassium capsules neoadjuvant ttherapy for locally advanced gastric cancer(ct2-4/n+m0)


Eligibility criteria:
inclusion criteria: 1. age from 18 to 75 years 2. primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. ct2-4n+m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition 4. no distant metastasis is observed. and the spleen, pancreas or other adjacent organs are not involved by the tumor. 5. performance status of 0 or 2 on eastern cooperative oncology group scale (ecog) 6. without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer. 7. estimate life is equal or greater than 3 months 8. no serious heart, lung, liver dysfunction;no jaundice and obstruction of the digestive tract; no acute infection 9. the main organ function is normal,and meet the following criteria: * blood routine examination( no blood transfusion within 14 days) 1. hb≥100g/l， 2. wbc≥3.5×109/l 3. anc≥1.5×109/l， 4. plt≥100×109/l； * blood biochemical examination 1. bil \<1.5 upper limit of normal（uln）， 2. alt and ast\<2.5uln，gpt≤1.5×ult； 3. cr≤1uln，creatinine clearance\>60ml/min（cockcroft-gault formula） 10. written informed consent exclusion criteria: 1. pregnant and lactating women 2. suffering from severe mental disorder 3. history of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. history of previous chemotherapy or radiotherapy therapy 5. history of other malignant disease within the past 5 years 6. history of previous neoadjuvant chemotherapy or radiotherapy 7. history of unstable angina or myocardial infarction within the past 6 months 8. history of cerebrovascular accident within the past 6 months 9. history of continuous systematic administration of corticosteroids within 1 month 10. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 11. patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),the history of hematemesis and melena within 2 months,coagulation disorders(inr\>1.5、aptt\>1.5 uln). 12. positive urinary protein(uric albumen check(++),or twenty-four hours urinary protein content\>1.0g) 13. there are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction 14. drug allergy to experimental medicine
the swedish study of irrigation fluid temperature in the evacuation of chronic subdural hematoma

Conditions: Chronic Subdural Hematoma

Summary: the study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.


Eligibility criteria:
inclusion criteria: * patients with chronic subdural hematoma requiring burr hole evacuation. * patients older than 18 years of age. exclusion criteria: * chronic subdural hematoma requiring surgical treatment other than burr hole evacuation. * chronic subdural hematoma in a patient with an intracranial arachnoidal cyst. * chronic subdural hematoma in a patient with a cerebro spinal fluid-shunt. * patients who have undergone intracranial surgery before.

Keywords: chronic subdural hematoma irrigation recurrence burr hole evacuation temperature
the neurologically-impaired extubation timing trial (neuro-ett)

Conditions: Acute Brain Injury

Summary: this trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. these patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. this is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. as patients recover, it is often unclear when the best time is to remove the breathing tube. doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). each of these approaches has risks and benefits. this trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Eligibility criteria:
inclusion criteria: 1. age \> 16 years 2. acute brain injury (subarachnoid hemorrhage, diffuse axonal injury, ischemic stroke, intracerebral hemorrhage, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis, cerebral abscess, epidural hematoma, subdural hematoma, seizure) that occurred within the previous 4 weeks 3. receiving mechanical ventilation via endotracheal tube for ≥ 48 hours exclusion criteria: 1. quadriplegic 2. neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to guillain-barre syndrome, cervical spinal cord injury, advanced multiple sclerosis 3. do-not-reintubate order in place 4. previously randomized in this trial 5. underlying pre-existing condition with life expectancy less than 6-months 6. current enrolment in an rct that precludes neuro-ett co-enrollment

Keywords: subarachnoid hemorrhage diffuse axonal injury ischemic stroke intracerebral hemorrhage brain tumor global cerebral anoxia/cardiac arrest meningitis/encephalitis cerebral abscess epidural hematoma subdural hematoma seizure
the effect of breathing on cognitive performance and stress

Conditions: Stress; Acute Stress Reaction; Breathing Techniques; Cognitive Performance

Summary: the purpose of this study is to determine the effectiveness of different breathing techniques on biomarkers of stress and cognitive performance following the trier social stress test.

this study examined the effect of three various breathing techniques (i.e., normal breathing, prolonged exhalation, and box breathing) on biomarkers of stress and mental performance after the trier social stress test (tsst). the tsst has been shown to result in significant increases in psychological and physiological stress markers. therefore, the goal of this study was to examine potential interventions to mitigate the effects of this psychological stressor while maintaining increased cognitive performance. moreover, previous literature has shown various effects of breathing interventions, therefore, the investigators wished to further validate breathing techniques as an effective tool to mitigate stress and increase cognitive performance. the data from this research provided insight to real life events, allowing for a principal understanding of how to reduce stress, focused at first responder populations.

Eligibility criteria:
inclusion criteria: * generally healthy * between the ages of 18-39, * student at texas state. exclusion criteria: * any known cardiovascular or metabolic disease * consuming any medication for psychiatric disorders (i.e., anxiety, depression, adhd) * being diagnosed with any psychiatric or physical conditions * any major stressors in the last 30 days (i.e., birth of a child, abortion, divorce).

Keywords: stress trier social stress test acute stress breathing technique box breathing cognitive performance biomarkers
mechanisms of exercise resistance in metabolic disease

Conditions: Impaired Glucose Tolerance

Summary: this project will determine exercise capacity and molecular markers of the response to acute exercise in human subjects with impaired or normal glucose tolerance.

low exercise capacity is an early clinical marker of metabolic impairment that predicts type 2 diabetes (t2d) risk, as well as future co-morbidities and complications. aerobic exercise training is the only effective treatment to increase exercise capacity and reduce metabolic risk. however, despite maintaining similar levels of physical activity, exercise capacity remains lower in people with impaired glucose tolerance and t2d, compared to those with normal glucose tolerance, suggesting "exercise resistance". the mechanisms of exercise resistance in metabolic disease are unknown. in preclinical studies, exercise-induced increases in circulating angiogenic markers and skeletal muscle capillary density predict improved exercise capacity with training. furthermore, it was demonstrated that impaired glucose tolerance precedes exercise resistance and impaired exercise-induce angiogenesis in muscle. based on these data, it was hypothesized that exercise resistance in human t2d is caused by an impaired angiogenic response to exercise, secondary to impaired glycemic control. this study will determine whether the angiogenic response to a single bout of exercise in human subjects is blunted in patients with impaired glucose tolerance (igt), compared to those with normal glucose tolerance (ngt). angiogenic potential will be measured using a novel in vitro assay developed to assess endothelial tube-formation induced by circulating serum angiogenic regulators following exercise. in addition, a novel exercise-activated signaling pathway in skeletal muscle that is predictive of exercise resistance in animal models was identified. a second aim of the proposed investigation is to determine the effect of impaired glucose tolerance on molecular signaling in response to exercise in skeletal muscle. this investigation represents a critical step in determining the mechanisms that contribute to low exercise capacity in individuals at risk for diabetes.

Eligibility criteria:
inclusion criteria: * age 18-45, bmi 26-32 kg/m2, sedentary lifestyle exclusion criteria: * type 1 or type 2 diabetes, heart or lung disease, hypertension, contraindications to exercise testing, pregnancy

Keywords: exercise cardiorespiratory fitness skeletal muscle angiogenesis
enhanced room cleaning in intensive care units to reduce gown and glove contamination with multi-drug-resistant bacteria

Conditions: Infection Control

Summary: the purpose of this study is to determine whether extra cleaning of frequently-contaminated surfaces in intensive care rooms is effective in preventing contamination of disposable isolation gowns and gloves with multi-drug resistant bacteria.

hospital infections are often caused by bacteria such as methicillin-resistant staphylococcus aureus (mrsa) or multi-drug-resistant acinetobacter baumannii (mdrab). hospital infections increase the cost of health care, length of hospital stay, and mortality compared to infections with antibiotic-susceptible organisms. many of these antibiotic-resistant bacteria are transmitted by patient-to-patient contact. healthcare workers are one possible vector of patient-to-patient transmission. transient colonization of hands, clothing and protective equipment can leads to the colonization and infection of other patients. the surfaces of patient rooms are also frequently contaminated with antibiotic-resistant bacteria. a number of recent studies have concluded that patient rooms are not cleaned thoroughly or frequently enough to keep commonly touched surfaces free of bacterial contamination. given the frequency of contact between the healthcare worker and the patient's environment, bacteria that contaminate environmental surfaces while the patient is in the room are a significant potential reservoir for patient-to-patient transmission via the hands of healthcare workers. in this study, the investigators will examine rooms of intensive care unit patients colonized with mrsa or mdrab. the investigators will randomize these rooms to receive either standard room cleaning plus a cleaning of high-touch surfaces ('enhanced cleaning') or to receive only standard room cleaning plus a sham cleaning of high-touch surfaces ('sham enhanced cleaning'). the investigators will then culture healthcare workers' disposable isolation gowns and gloves as they exit the enrolled room after routine patient care activities. the investigators will examine the cultures for the presence of mrsa or mdrab to determine whether additional cleaning significantly reduces the proportion of healthcare workers with contaminated gloves and gowns, and therefore may reduce the risk of transmitting these bacteria to other patients. the results of this trial will help guide future efforts to decrease patient-to-patient transmission of antibiotic-resistant bacteria.

Eligibility criteria:
inclusion criteria: * room is occupied by a patient colonized with methicillin-resistant staphylococcus aureus and/or multi-drug-resistant acinetobacter baumannii * occupant of the room is on contact precautions * occupant was admitted to the room at least 24 hours prior to the time of screening exclusion criteria: * room is occupied by a patient who occupied another room at the time it was enrolled and followed.

Keywords: antibiotic resistant bacteria colonization hospital cleaning environmental cleaning infection control
efficacy and safety study of bf2.649 and bf2.649 add on modafinil on cataplexy in patients with narcolespy

Conditions: Narcolepsy; Cataplexy; Excessive Daytime Sleepiness

Summary: the objective of this study is to evaluate and compare the efficacy and safety of escalating doses of bf2.649 and bf2.649 add on modafinil on cataplexy in patients with narcolepsy

bf 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies. the objective of this poc study are firstly to evaluate and compare the efficacy and safety of escalating doses of bf2.649 and bf2.649 add on modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of bf2.649 and modafinil on eds as assessed by both of objective and subjective measures including ess, mwt, patients sleep diary.

Eligibility criteria:
inclusion criteria: * "de novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for excessive daytime sleepiness(eds) and cataplexy * patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for eds and cataplexy for more than 3 months * partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ess \>or= 14 at the end of the baseline period exclusion criteria: * patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances * current or recent history of a substance abuse or dependence disorder including alcohol abuse * psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation

Keywords: narcolespy cataplexy excesssive daytime sleepiness sleep disorders sleep attacks orphan drug pitolisant
effect of h.pylori infection on growth parameters

Conditions: HELICOBACTER PYLORI INFECTIONS

Summary: this study aimed to assess the effect h.pylori infection on growth parameter of primary school-aged children attending assuit university chilren hospital

undernutrition is caused by insufficient intake, malabsorption, inadequate utilization, and increased demand. there is a positive association between undernutrition and various infections. chronic exposure to pathogens may affect nutrient absorption and increase nutrient consumption, among many potential pathogens, chronic helicobacter pylori (h. pylori) infection may be one cause of undernutrition. h. pylori is a gram-negative, helical, and microaerophilic bacterium, which colonizes gastric epithelial cells' surface. the mode of transmission of h. pylori is not known exactly, but the faecal-oral or oral-oral routes via water or food consumption are thought to be a very common cause. the frequency of h.pylori infection increases with age. the rate of development is higher in societies with low socioeconomic status . the worldwide prevalence of h. pylori in children varies significantly, from 2.5% in japan to 34.6% in ethiopia. gastric mucosal host factors, as well as environmental and virulence factors of the bacteria, are associated with the clinical outcome of h. pylori infection. it is closely related to chronic gastritis, dyspepsia, and chronic diarrhea. h pylori also remains an important risk factor for duodenal ulcers and duodenal and gastric erosions in children.a number of studies identified correlations of h pylori infection in children with a variety of gastrointestinal diseases including autoimmune gastritis and celiac disease. it also produces different biological effects on hormones such as ghrelin and leptin, which control both growth and appetite, causing changes in appetite and food intake, while causing changes in immunological symptoms and responses .h. pylori is a factor that causes malnutrition and growth retardation, due to malabsorption of nutrients and increased susceptibility to enteric infections, especially in developing countries .

Eligibility criteria:
inclusion criteria: 1. primary school children aged 6 to 12 years old. 2. children who have tested positive for helicobacter pylori. exclusion criteria: 1. children with primary malnutrition due to nutritional deficiency . 2. children with chronic illness
early cardiac extubation after cardiac surgery

Conditions: Post-operative Cardiac Surgery

Summary: the management of heart valve disease is constantly evolving over time. the minimally invasive approach (mini-thoracotomy and j-hemisternotomy) is one of the major surgical evolutions. it has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability this evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. in particular, immediate postoperative extubation appeared feasible. the investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. the investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.


Eligibility criteria:
inclusion criteria: * minimally invasive valve replacement intervention (thoracotomy or j-hemisternotomy) exclusion criteria: * combined surgery

Keywords: post-operative complications on table extubation
light, exercise intensity and mood in overweight

Conditions: Overweight, Obesity Grade I

Summary: the purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.


Eligibility criteria:
inclusion criteria: * body mass index 25 - 35 kg/m2 exclusion criteria: * women who are pregnant or breast feeding, * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * previous enrolment into the current study * participation in other studies in the last four weeks * systolic blood pressure \> 170 mmhg, diastolic blood pressure \> 100 mmhg * shift work in the last two months * travels across time zones in the last four weeks * use of photosensitisation drugs * clinical manifest depression * cardiovascular diseases which reduce age-appropriate exercise capacity
distraction using vr for children during iv in an emergency department

Conditions: Pain; Fear

Summary: exploring the use of virtual reality as a distracting intervention strategy for school-age children to receive intravenous placement in emergency department, and further understand the effectiveness of reducing pain and fear during the invasive procedure.


Eligibility criteria:
inclusion criteria: * children ages 7-12 * children who were clearly conscious * children who agreed and were required to receive intravenous injections after physicians' diagnoses * children and their primary caregivers who could communicate in mandarin or taiwanese * children and their primary caregivers who could read chinese that agreed to participate in this study and sign written consent forms exclusion criteria: * children with developmental delay, epilepsy, or heart diseases * children undergoing chemotherapy; children who were visually or hearing impaired * children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters * children who had sustained head trauma in the past month * children who were confirmed to be obese according to the recommended body mass index values for children and adolescents * children who required blood transfusions and blood preparation to be performed according to physician diagnoses * children who received two or more intravenous injections and had their blood drawn only one time

Keywords: school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear