Kornimate/medical-research-clean huggingface dataset:
treatment of unilateral complicated zygomatic complex fractures using computer-assisted navigation system

Conditions: Zygomatic Fractures

Summary: many studies show that computer-assisted navigation system have been available to treat zygomatic-complex fractures. however, most of them are case reports or clinical experiences lacking multiple variables and controlled design. the aim of this study was to evaluate the accuracy of the computer-assisted navigation system by a randomized controlled trial with multiple variables.

in this prospective randomized controlled trial, twenty patients with unilateral complicated zygomatic fractures were divided into experimental and control groups. patients in the experimental group were treated with open reduction and internal fixation with the assistance of surgical navigation technology, and patients in the control group without it. preoperative and postoperative ct data were obtained to measure surgical landmarks discrepancy between the 2 groups. the chi-square test and t-test were conducted to test whether there was significant difference in the accuracy between the two groups. evaluating the effect of fixation by the data and clinical symptoms. twenty patients with unilateral complicated zygomatic-complex fractures received operation. all patients healed and their function and facial contour were improved obviously. postoperative clinical symptoms were not significantly different between the two groups (p\>0.05). compared with the control group, discrepancy of surgical landmarks measured by software geomagic studio 11, brainlabiplan cmf 3.0 were significantly low in the experimental group (p\<0.05). software measurement showed the symmetry of zygomatic area and the effect of the fixation in the experimental group were more satisfactory than the control group.

Eligibility criteria:
inclusion criteria: * unilateral zmc fractures including complete monofragment zygomatic or tetrapod fracture, multifragment or comminuted fracture * patients were sane and the age were between 18 to 60 years * patients suffered facial deformity and dysfunction which need be treated by operation * there is no contraindication in patients * the study were conducted after patient's informed consent exclusion criteria: * cases in which technical problems or registration fails occur and patients who were lost to follow-up within 1 year are excluded from this study.

Keywords: computer-assisted navigation system
how does dietary carbohydrate influence the formation of an atherogenic lipoprotein phenotype (alp)?

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Summary: the hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar. we predict that this potentially adverse effect of dietary sugars on blood lipids will be more pronounced in people with a raised level of stored fat inside their liver, as compared to people with a low level of stored fat.

this study aims to determine the metabolic mechanism(s) by which dietary extrinsic sugars (sucrose and fructose), promote the formation of a high risk dyslipidaemia, known as an atherogenic lipoprotein phenotype (raised plasma triglyceride, low hdl and predominance of small, dense ldl), in men with raised cardio-metabolic risk and percentage of liver fat, as determined by magnetic resonance spectroscopy (mrs). the study examined the impact of diets high and low in extrinsic sugars, on the metabolism of lipids and lipoproteins in vivo, of two groups of men with a high (\>10%)and low (\<2%)percentage of liver fat, by the trace-labelling of these lipid moieties with stable isotopes, and detection by gas chromatography mass spectrometry. the study had a two-way cross-over design, with two, 12 week dietary interventions separated by a six week wash-out period. the dietary intervention with high and low sugars was achieved by a dietary exchange with supermarket foods, which were consumed within the homes of the participants.

Eligibility criteria:
inclusion criteria: * male gender, * increased cardio-metabolic risk ('risck' criteria jebb et al (2010) am j clin nutr 92, 748-758). * apo e3e3 genotype exclusion criteria: * any abnormal result in blood screen (renal and liver function, haematology) * diabetes * smoker * excessive alcohol consumption (\>27units/week) * medication likely to affect lipid metabolism * \>3kg weight loss in preceding 3 months * any medical condition (eg. gi tract, allergies) affecting lipid metabolism or ability to comply with dietary interventions * involvement in any other study

Keywords: sugars, fatty liver, lipoprotein kinetics, triglycerides
in vivo and ex vivo validation of mr tractography of brain white matter tracts - fibratlas ii-iii

Conditions: Neurological Diseases

Summary: white matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. these tracts form the internal part of the brain and transmit the nervous impulses. changes in brain white matter may serve as biomarkers for numerous neurological diseases. diffusion weighted imaging (dwi) is a non-invasive mri (magnetic resonance imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. several validation techniques were previously proposed, none of them being fully convincing in human.


Eligibility criteria:
inclusion criteria: * prior enrollment in a body donation program * age ≥ 82 years * absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the iadl (4 items) (lawton and brody, 1969) * distance to one of the participating laboratories ≤ 120km * able to remain supine in the mr scanner for acquisition duration (60 min), * affiliation to social security * informed and written consent non inclusion criteria: * past or present neurological or neurosurgical diseases (excluding trauma or degenerative spinal lesions) * uncontrolled: high blood pressure, diabetes (types i or ii), or dyslipemia * contraindications to mri * contraindication to body donation exclusion criteria * diagnosis on mri of brain lesions, excepted common age-related changes

Keywords: mri tractography white physiology analysis matter tracts
radiation therapy in treating patients with metastatic spinal cord compression

Conditions: Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. it is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression. purpose: this randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.

objectives: * to examine whether a phase iii randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression. * to determine the feasibility of conducting this study in the united kingdom. outline: this is a multicenter study. patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease \[spinal metastases only vs spinal and non-bony metastases\]). patients are randomized to 1 of 2 treatment arms. * arm i (multi-fraction radiotherapy): patients undergo 5 fractions of 20 gy external-beam radiotherapy. * arm ii (single-fraction radiotherapy): patients undergo 1 fraction of 8 gy external beam radiotherapy. patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed malignant disease * proven diagnosis of metastatic spinal cord compression on mri or ct scan * single site of compression or multiple sites that can be treated within a single radiation treatment field * no patient for whom surgery or chemotherapy treatment is more appropriate * no multiple myeloma as primary cancer patient characteristics: * life expectancy \> 1 month * not pregnant * willing and able to complete assessment forms * able to give informed consent prior concurrent therapy: * see disease characteristics

Keywords: spinal cord compression unspecified adult solid tumor, protocol specific
synergy: open study of enoxaparin versus unfractionated heparin in patients with acute coronary syndromes

Conditions: Unstable Angina; Myocardial Infarction; Myocardial Ischemia

Summary: patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.


Eligibility criteria:
inclusion criteria * male or nonpregnant female greater than or equal to 18 years old * ischemic pain originating or persisting at rest, or its clinical equivalent, lasting greater than or equal to 10 minutes and occurring within the 24 hours before enrollment * at least 2 of the following: * ecg changes: new or presumably new st-segment depression greater than or equal to 0.1 mv (greater than or equal to 1 mm), or transient (\<30 minutes) st-segment elevation greater than or equal to 0.1 mv (greater than or equal to 1 mm) in at least 2 contiguous leads * abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin i or t greater than the established criteria at each site or creatine kinase ck-mb level greater than the site's upper limit of normal * age greater than or equal to 60 years exclusion criteria: * known or suspected pregnancy * increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (\<1 month) trauma or major surgery (including bypass surgery); active bleeding * impaired hemostasis: known international normalized ratio (inr) \>1.5; past or present bleeding disorder (including congenital bleeding disorders such as von willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/ml), or history of thrombocytopenia with gp iib/iiia inhibitor therapy, heparin, or enoxaparin * angina from a secondary cause such as severe, uncontrolled hypertension (systolic blood pressure \>180 mm hg despite treatment); anemia; valvular disease; congenital heart disease; hypertrophic cardiomyopathy; restrictive or constrictive cardiomyopathy; thyrotoxicosis * pci within the past 24 hours, not including coronary angiography only * allergy to pork or pork products * contraindications to ufh or lmwh * recent (\<48 hours) or planned spinal/epidural anesthesia or puncture * thrombolytic therapy within the preceding 24 hours * other serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 ml/min * treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial * inability to give informed consent or high likelihood of being unavailable for follow-up * not a candidate for intervention, (angiography or pci) * treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.

Keywords: acute coronary syndromes non-st-segment elevation
auriculotemporal nerve block in tmj disorders

Conditions: Temporomandibular Joint Disorders; Arthralgia of TMJ

Summary: the retrospective study aimed to evaluate the efficacy of the auriculotemporal nerve block (atnb) in achieving unrestricted mouth opening amount and in reducing the pain scores in those patients diagnosed with disc displacement with (ddwr) and without reduction (ddwor) according to the diagnostic criteria for temporomandibular disorders, who could not benefit from noninvasive methods but did not want further invasion.

the records of 410 patients referred to the department of oral and maxillofacial surgery with tmd symptoms were reviewed to determine the treatment modalities used and their outcomes. the subjects were examined and diagnosed according to the turkish translation version of the diagnostic criteria for temporomandibular disorders (dc/tmd-axis 1 questionnaire and examination form). the pain intensity, maximal mouth opening (mmo) amounts, and self-reported outcome variables of twenty-two patients who underwent non-invasive therapies (occlusal stabilization splints, behavioral modifications, physical therapy, pharmacotherapy) but did not benefit from them and volunteered for the atnb instead of invasive therapies (arthrocentesis, arthroscopy, and discectomy) were also evaluated. prior to the atnb, written informed consent was obtained from each participant. also, each participant was warned about complications of the atnb before the administration, such as hematoma at the injection site, positive aspiration, and temporary anesthesia of the facial nerve.

Eligibility criteria:
inclusion criteria: * underwent non-invasive therapies (occlusal stabilization splints, behavioral modifications, physical therapy, pharmacotherapy) but did not benefit from them and volunteered for the atnb instead of invasive therapies (arthrocentesis, arthroscopy, and discectomy). exclusion criteria: patients with * symptoms of the diseases possibly related to tmd (e.g., fibromyalgia, hypothyroidism, scleroderma, rheumatoid arthritis) * orofacial disorders that might have been responsible for the tmd symptoms (e.g., neuralgia, migraine, myositis, trauma, neuropathic pain, infections) * complications due to atnb (e.g., temporary facial nerve palsy, hematoma, positive aspiration) * history of invasive therapies or tmj surgeries

Keywords: auriculotemporal nerve block temporomandibular disorders physiotherapy anesthesia local
a phase 1 study of osilodrostat (lci699) in healthy volunteers and subjects with impaired hepatic function

Conditions: Hepatic Impairment

Summary: to assess the pharmacokinetics of a single oral dose of osilodrostat (lci699) 30 mg in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.


Eligibility criteria:
inclusion criteria: * weight ≥50 kg and bmi between 18-38kg/m2. * stable liver cirrhosis and evidence of hepatic impairment. * free of significant medical disorders unrelated to underlying hepatic impairment exclusion criteria: * history of any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs * subjects with ongoing alcohol or drug abuse * symptoms or history of encephalopathy (grade 2 or above) * history or presence of liver disease or liver injury (healthy volunteers only) * history or presence of impaired renal function * clinical evidence of severe ascites. * total bilirubin \> 6 mg/dl, * subjects with a serum free cortisol test results that is below the lower limit of normal (based on central laboratory) during the screening period * concomitant use of a drug that is a strong inducer of the cyp3a4/5 pathway other protocol-defined inclusion/exclusion criteria may apply -

Keywords: hepatic impairment, osilodrostat, lci699
metabolism and pharmacokinetics of primaquine enantiomers in human volunteers, study 1

Conditions: Malaria

Summary: to investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of pq in healthy human volunteers. the specific aim is the comparative evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of pq (rpq and spq and the racemic mixture rspq) in normal healthy human volunteers.

the primary objective of this project is to investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of pq in healthy human volunteers. the overall approach is as follows: in 36 healthy volunteers with documented normal g6pd activity, we will administer a single oral dose of rpq, spq, or rspq. at various times after dosing, we will draw blood samples, in which we will record the plasma levels of the parent drugs, along with plasma and urinary metabolites. the comparative pharmacokinetics, tolerability and hematological effects of these two enantiomers and the racemate will be assessed.

Eligibility criteria:
inclusion criteria: * adults (18-60 years of age) * informed consent * healthy exclusion criteria: * known history of liver, kidney or hematological disease; * known history of cardiac disease, arrhythmia, qt prolongation; * autoimmune disorder; * report of an active infection; * evidence of g6pd deficiency
tramadol for labour analgesia in low risk primiparous women

Conditions: Pain During Labour

Summary: tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. it has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). the purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.


Eligibility criteria:
inclusion criteria: * gestational age between 37 and 40 6/7 weeks * primiparous patient * singleton * 4 to 5 cms of dilation * intact membranes or spontaneous rupture of membranes less than 2 hours * fetus in a vertex presentation * gynecoid pelvis by clinical examination exclusion criteria: * multiparous * multiple pregnancies * any pathology * induction of labour with prostaglandins

Keywords: pain during labour duration of labour apgar score umbilical cord ph
non invasive electrical impedance technology (eit) for diagnosing liver diseases severity

Conditions: Chronic Liver Disease; Fibrosis, Liver; Non-Alcoholic Fatty Liver Disease

Summary: the aims of this study are to assess the performance of the non-invasive electrical impedance technology (eit) in evaluating the liver fibrosis stage in patients with chronic liver diseases, in comparisons with a liver biopsy and/or shear wave elastography and liver ultrasonography. the second aim is comparing between liver ultrasonography and electrical impedance technology (eit) to quantify the hepatic steatosis grade in patients with non alcoholic fatty liver disease (nafld) .

the study will include 210 patients with chronic liver diseases. relevant clinical data such as sex, age, weight, height, alcohol intake, medical history and routine lab results will be collected. the study will include three groups: 1. patients with indication for liver biopsy will undergo a routine liver biopsy and also routine liver ultrasonography, shear wave elastography and electrical impedance technology (eit) (70 patients). 2. patients with chronic liver diseases will undergo routine liver ultrasonography, shear wave elastography and electrical impedance technology (eit) (70 patients). 3. patients with non alcoholic fatty liver disease will undergo routine liver ultrasonography, shear wave elastography and quantification of liver steatosis using the electrical impedance technology (eit) (70 patients).

Eligibility criteria:
inclusion criteria: * patients with chronic liver diseases exclusion criteria: * patients who don't have chronic liver diseases
albumin-bound paclitaxel followed by epirubicin in combination with cyclophosphamide in triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this is an open-label, single arm, two-stage simon design study for women with triple negative breast cancer treated with nanoparticle albumin-bound paclitaxel and carboplatin. the primary objective of the trial is to evaluate of the efficacy and safety of weekly nanoparticle albumin-bound paclitaxel(nab-p) followed by dose-intensive epirubicin in combination with cyclophosphamide as neoadjuvant chemotherapy in triple negative breast cancer. the primary endpoint of the study is to to assess pathological complete response rate（pcr）using the response evaluation criteria in solid tumors (recist 1.1).. the total number of patients to be included in this study is 60 patients. the duration of the study, from first patient visit to last patient visit will be approximately 19 months.


Eligibility criteria:
inclusion criteria: 1. age: from 18 to 70 years old, female. 2. has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of t2-4nanym0. 3. the expression of er, pr, her-2 was negative by immunohistochemistry (ihc), if her2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no her-2 gene amplification. 4. at least one measurable objective lesion according to recist 1.1 criteria. 5. ecog performance status of 0-1. 6. lvef≥55%. 7. bone marrow function: neutrophils ≥ 1.5×109/l, platelets ≥ 100×109/l, and hemoglobin ≥ 90 g/l. 8. liver and renal function: serum creatinine ≤ 1.5 times the upper limit of normal. ast and alt ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with gilbert's syndrome. 9. has good compliance with the planned treatment, understand the study process and sign written informed consent. exclusion criteria: 1. any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. 2. patients with grade ii or higher heart disease scored by the new york heart association (nyha). 3. severe systemic infection, or with other serious diseases. 4. patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients. 5. other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma. 6. pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial. 7. have participated in other study studies within 30 days prior to the first dose of study drug. 8. patients who, in the opinion of the investigator, are not suitable for participation in the study.

Keywords: neoadjuvant chemotherapy
combination of remimazolam and propofol during drug-induced sleep endoscopy

Conditions: Sedative Effect During Drug-induced Sleep Endoscopy; Obstructive Sleep Apnea (OSA)

Summary: this study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy


Eligibility criteria:
inclusion criteria: * patients diagnosed with sleep apnea hypopnea syndrome were included exclusion criteria: * patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.

Keywords: drug-induced sleep endoscopy remimazolam propofol obstructive sleep apnea airway collapsibility