Kornimate/medical-research-clean huggingface dataset:
drug interaction study of sorafenib and rapamycin in advanced malignancies

Conditions: Advanced Solid Tumor

Summary: the goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib. this study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.


Eligibility criteria:
inclusion criteria: * solid cancer for which curative measures have failed or for which there is no known superior treatment * ecog performance status 0-2 * measurable or non-measurable disease * life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks * age 18 years or older * patients must have adequate organ and marrow function as defined below: * alt and ast less than or equal to 2.5 x the uln (\< 5 x uln for patients with liver involvement). * hemoglobin greater than or equal to 9 g/dl * absolute neutrophil count greater than or equal to 1,500/μl * platelets greater than or equal to 100,000/μl (greater than or equal to 35,000/μl without transfusion for patients with cll/sll or follicular lymphoma) * total bilirubin less than or equal to 1.5 x uln * creatinine less than or equal to 1.5 x uln * women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment. * ability to understand and the willingness to sign a written informed consent document * must not have any evidence of bleeding diathesis. exclusion criteria: * patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study * patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy * patients with uncontrolled brain metastases. * concurrent illness or medication exclusions * hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.

Keywords: metastatic advanced disease phase i
comparing pain and kinematic outcomes of two gait-modifying shoe interventions

Conditions: Arthritis Knee

Summary: this study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.

this study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. this is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis. the purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.

Eligibility criteria:
inclusion criteria: * chronic, oa-related knee pain * diagnosis of medial compartment knee oa (unilateral or bilateral) * moderate pain of ≥4 out of 10 points while performing a weight-bearing activity * kellgren and lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray within the last 2 years prior to enrollment * able to walk unassisted for at least 10 minutes at a time * wear a women's shoe size of 6.5 to 13 or a men's shoe size of 5 to 12. exclusion criteria: * patients suffering from acute septic or inflammatory arthritis * unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, moderate workload trials * received a corticosteroid injection or invasive procedures within prior 6 months of the study * history of avascular necrosis in the knee * history of knee buckling * joint replacement in any lower extremity joint that has not optimally recovered (e.g. still causes significant pain or affects mobility) as determined by the pi. * experienced more than 3 falls within the last year * currently using any knee brace on a regular basis for the knee pain, with the exception of basic knee sleeves * pathological osteoporotic fracture * severe symptomatic degenerative arthritis in lower limb joints other than the knees * severe back pain, prior spinal fusion or spinal deformity that would affect gait * major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer * knee flexion contracture greater than 15° * knee flexion of less than 90° * any major injury to either knee within the prior 12 months * currently enrolled in a supervised physical therapy program

Keywords: osteoarthritis (oa) gait modifying shoe
anticoagulation medicine in surgical repair for total anomalous pulmonary venous connection

Conditions: Total Anomalous Pulmonary Venous Connection

Summary: total anomalous pulmonary venous connection (tapvc) is a complex congenital heart disease, requiring surgical repair. pulmonary venous obstruction (pvo) is the major complication, with limited effective reinterventions and poor outcomes. this trial aims at investigating that postoperative anticoagulant management reduce the incidence of pvo.

total anomalous pulmonary venous connection (tapvc) is a complex congenital heart disease, with all the pulmonary veins connecting to the right heart system through collateral vessels, accounts for about 3% of congenital heart disease. pulmonary venous obstruction (pvo) is a major complication, with limited effective reinterventions and poor outcomes. the major challenge for surgical repair of tapvc is to lower the incidence of pvo. previous studies in our center showed the abnormal coagulation function, such as elevated international normalized ratio (inr), and decreasing of prothrombin activity, are associated with a higher rate of pvo. some researches suggested that postoperative application of anticoagulants might reduce the incidence of pvo, however, the evidences are still limited. this trial will randomize patients to receive either conventional postoperative management or continuous infusion anticoagulant (heparin) until the removal of deep vein catheter. the primary endpoint will be incidence of pvo, days of chest drainage more than 40ml/d, and mortality rate. secondary endpoints including readmission, functional capacity assessment, quality of life and incidence of complications will also be collected.

Eligibility criteria:
inclusion criteria: * 1. infants and neonates who are diagnosed with tapvc * 2. infants and neonates who undergo initial surgical repair for tapvc exclusion criteria: * 1. concommitant diagnosis including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia or transposition of the great arteries. * 2. older than 1-year-old.

Keywords: total anomalous pulmonary venous connection (tapvc) anticoagulant management pulmonary venous obstruction (pvo) outcomes
staccato alprazolam abuse liability

Conditions: Abuse Liability of Staccato Alprazolam

Summary: compare the abuse liabilities of staccato alprazolam, oral immediate-release alprazolam, and staccato placebo.

the phase 1 clinical study compared the abuse liabilities of staccato alprazolam, oral immediate-release alprazolam, and staccato placebo in 14 subjects with a history of sedative abuse. subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and matching placebo over 2 sessions. those who demonstrated greater liking for alprazolam versus placebo were eligible to participate in the study.

Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 18 to 55 years, inclusive, who have a history of substance abuse or dependence on barbiturates and/or benzodiazepine receptor agonists for their intoxicating effects exclusion criteria: * subjects with a significant current psychiatric illness or taking any psychotropic prescription medications for therapeutic uses.
an efficacy and safety study of omega-3-acid ethyl ester in chinese subjects with hypertriglyceridemia.

Conditions: Hypertriglyceridemia

Summary: the primary objective was to investigate the effect of 12-week treatment of omacor on fasting serum triglycerides (tg) in chinese subjects with hypertriglyceridemia (htg). the secondary objectives were to investigate the safety and tolerability and effect of omacor on lipid parameters after 12 weeks treatment.

this was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of omacor or matching placebo in subjects with moderate or severe htg.

Eligibility criteria:
inclusion criteria: * baseline fasting serum tg level \> 200mg/dl and \<1000mg/dl, in subjects treated for htg. * if on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study. * able and willing to give written informed consent. exclusion criteria: * subjects taking fish oil capsules 8 weeks prior to inclusion in this study. * known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos). * pregnant of lactating females. * known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease. * significant hepatic disease. * significantly reduced renal function. * alcohol consumption \>30g for male and 20g for female daily. * concomitant use of other investigational drugs. * subject related to the investigator. * subject expected to be not compliant.
machine learning algorithm for predicting postoperative delirium in elderly patients after thoracic surgery

Conditions: Postoperative Delirium

Summary: postoperative delirium (pod) is a common and severe complication in patients undergoing major surgery, especially in the elderly. pod has been proven to be associated with increased morbidity and mortality, institutionalization, and high healthcare costs. this retrospective cohort study aimed to use machine learning methods to develop clinically meaningful models to support clinical decision making.

the primary outcome was the incidence of pod within 3 days postoperatively. the patients will be randomly split into two datasets with split ratios of 80% and 20%. subsequently, 80% of the patients will be used for training, and 20% of the patients will be used for testing. multiple machine learning algorithms will be used to develop pod risk prediction models. the discrimination ability of the prediction models will be assessed by calculating the area under the receiver operating characteristic curve (auc). the calibration of the model will be evaluated using the hosmer-lemeshow goodness of fit test. decision curve analysis (dca) will be used to evaluate the net benefits for each threshold probability. the best model will be selected by comparing the performance between the models. then the shapley additive explanations (shap) will be used to explain the best one.

Eligibility criteria:
inclusion criteria: * aged ≥ 65 years * elective segmentectomy, lobectomy, or esophagectomy surgeries * general anesthesia exclusion criteria: * surgery length less than 1 hour * preoperative cognitive dysfunction * admission to the intensive care unit * second operation within 24 hours * missing data for any variables

Keywords: postoperative delirium
comparison of salivary interleukin-1β and matrix metalloproteinase-8 levels in individuals with chronic periodontitis

Conditions: Chronic Periodontitis

Summary: periodontitis is an infectious inflammatory disease affecting the periodontal tissue (gingivae, alveolar bone, periodontal ligament and cementum). chronic periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of c- reactive protein, interleukins and matrix metallo-proteinases. interleukin- 1β and matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade of chronic periodontitis.various treatment modalities including scaling and root planing, toothpastes and chlorhexidine based mouthwashes have been are known to be associated with various side effects like teeth staining, altered taste sensation, mucosal burning. hence,the use of natural medicaments could provide a better alternative because of their fewer side effects and cost effectiveness.

periodontal disease is one of the most common diseases in humans and is responsible for most of the tooth loss in adults. world health organisation report of 2005 described that the global problem persisted with the worldwide oral diseases such as dental caries, periodontal disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. according to a local study the prevalence of periodontitis is found to be more in males of older age group and more in rural areas owing to the lack of awareness of importance of oral hygiene. apart from various conventional treatment option for periodontitis a number of herbal medicinal intervention have been used for its treatment. plant extracts and herbs that have been used previously used for periodontal therapy include salvadora persica, arnica montana and hamamelis virginiana which have been shown to exhibit antibacterial activity against periodonto-pathic bacteria. phytomedicines (medicines derived from herbal plants) like indian gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. propolis resin, guava and triphala have been also been used for the treatment of periodontitis

Eligibility criteria:
inclusion criteria: * male and female healthy individual * individuals diagnosed with chronic periodontitis according to the who criteria. * age 19 to 40 years. exclusion criteria: * patients with gingivitis only. * patients using tobacco products and alcohol. * underlying systemic pathology such as diabetes mellitus, cardiovascular disease, arthritis etc. * oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and oral carcinomas. * obese patients. * pregnant females. * xerostomia. * previous history of radiotherapy or chemotherapy. * positive history of oral prophylactic procedures (mouthwashes and antibiotics). * positive history of any periodontal treatment during last 6 months. * positive antibiotic therapy history within last month of study.

Keywords: chronic periodontitis phytomedicines nigella sativa
study to evaluate the long term safety and efficacy of dwp16001 in patients with type 2 diabetes mellitus

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. during visit 1 (screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. at visit 1-1, central laboratory tests will be conducted. if the test results meet the criteria for visit 2 (enrollment visit), the subject will be eligible to participate in the clinical trial. the subjects will receive the investigational drug (dwp16001 0.3 mg) once a day for 52 weeks. they will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

the subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. during visit 1 (screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs. at visit 1-1, central laboratory tests will be conducted. if the test results meet the criteria for visit 2 (enrollment visit), the subject will be eligible to participate in the clinical trial. the subjects will receive the investigational drug (dwp16001 0.3 mg) once a day for 52 weeks. they will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Eligibility criteria:
inclusion criteria: 1. subjects with t2dm age 19 \~ under 80 years 2. subjects who have 7% ≤ hba1c ≤ 11% in screening visit(v1-1) 3. subjects who have fpg \<270 mg/dl screening visit(v1-1) 4. subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to visit 2 (enrollment visit) 5. subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study exclusion criteria: 1. subjects with current or history of hypersensitivity to the ip of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or sglt2 inhibitors) 2. diabetic ketoacidosis, diabetic coma or precoma within the past year 3. urinary tract infections or genital infections within 4. uncontrolled hypertension (sbp \> 180 mmhg or dbp \> 110 mmhg) 5. egfr \< 45 ml/min/1.73 m2 6. severe heart failure (nyha class iii/iv
the efficacy of a cognitive and physical intervention to reduce head and muscle pain in a working community

Conditions: Migraine; Tension Type Headache; Cervical Pain

Summary: this study is a controlled, cluster randomised, interventional trial to evaluate the effectiveness of a workplace cognitive and physical program (intervention), in reducing the frequency of head and neck pain in an extensive working population.

many studies were performed to assess the efficacy of non invasive physical interventions in the treatment of different types of headache and cervical pain. however the evidence on their effectiveness is still limited and the results of recent studies are conflicting. in a previous non-randomized-controlled study in which the cognitive and physical programme was applied to a consistent number of office workers, a significant reduction of frequency of pain in the head and neck areas and of analgesic drug consumption was obtained. the present study was designed to confirm the data in a much more extensive working population and applying a randomised design. the primary objective is to confirm the effectiveness of a workplace cognitive and physical programme (intervention), in reducing the frequency of pain involving the head and neck area in a large working community using a randomized design.the intervention consists of brief shoulder and neck exercises to be performed several times a day, a relaxation exercise and instructions of how to reduce parafunction and hyperfunction of the craniofacial and cervical muscles during the day. secondary objectives: to confirm the effectiveness of the intervention, in reducing the intensity of pain involving the head and neck area in a large working community using a randomized design. to confirm the reduction in analgesic drugs consumption after the intervention in a large working community using a randomized design. to evaluate the persistence of the effectiveness of the intervention after 12 months in a large working community using a randomized design. comparison(s): group of employees that will receive a cognitive/physical programme (intervention), compared to a similar group of employees that will not receive the intervention (controls); (frequency of headache and neck and shoulder pain).

Eligibility criteria:
inclusion criteria: * all the subjects employed at the municipality of turin at september, 2007 will be recruited. exclusion criteria: * because of the pragmatic design, no exclusion criteria are required for this study.

Keywords: headache cervical pain cognitive treatment relaxation exercise
effect of acetazolamide and methazolamide on hypoxic exercise performance

Conditions: High Altitude Effects

Summary: a single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. participants will be young (under 40 years of age), healthy males and females who are regularly physically active.


Eligibility criteria:
inclusion criteria: * consent provided * between ages of 18-40 years old * in good general health as evidences by medical history * perform at least 150 mins of aerobic exercise per week, and engage in physical activity \>2 days a week * completed in an endurance event in the last 12 months * ability to take oral medication, and be willing to adhere to the drug regimen * be willing to have blood samples taken exclusion criteria: * weigh 49kg or less, or are obese (bmi \>30 kg/m2) * presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders: 1. cardiovascular - e.g., hypertension 2. metabolic - e.g., type 1 or 2 diabetes 3. respiratory - e.g., chronic obstructive pulmonary disease, asthma 4. digestive - e.g., ulcerative colitis 5. arthritis 6. cancer * presence of any disorder or condition listed in the health screening questionnaire (see section 12.1) * current use of lonafarnib, methenamine, topamax, or steroids/corticosteroids * known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or sulfonamides * presence of bleeding or clotting disorders * current smoker or cannabis user * pregnant, suspect to be pregnant, currently planning a pregnancy, or nursing * any condition or diagnosis, that could in the opinion of the principal investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Keywords: exercise
sleep timing and energy balance

Conditions: Sleep; Meals

Summary: the purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults. this study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late). the aims and hypotheses of this study are: aim 1: to compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing. * hypothesis 1: there will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile. * hypothesis 2: there will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin. aim 2: to compare food intake over a 24-h period in response to altered sleep and meal timing. • hypothesis 3: energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.


Eligibility criteria:
inclusion criteria: * body mass index 22-25 * normal scores on sleep questionnaires (psqi, ess, berlin, sdiq) * normal score on beck depression inventory * intermediate chronotype on composite scale of morningness/eveningness exclusion criteria: * neurological, medical, or psychiatric disorders * eating disorders * diabetes * sleep disorders * travel across time zones * history of drug/alcohol abuse * caffeine intake \>300 mg/d * excessive daytime sleepiness * pregnancy or within 1 y post-partum

Keywords: sleep sleep duration meals food intake obesity