Kornimate/medical-research-clean huggingface dataset:
ankle-brachial index estimating cardiac complications after surgery

Conditions: Cardiovascular Complications; Myocardial Infarction; Acute Coronary Syndromes

Summary: introduction: patients undergoing noncardiac surgery are at increased risk of cardiovascular complications. the development of methods that can accurately predict the occurrence of these events is of critical importance and large studies have been published with this purpose. based on these studies, several algorithms have been proposed to predict of cardiovascular events postoperatively. however, quantification of this risk is often difficult to measure, especially in those patients with subclinical disease, not always detected in routine evaluation. the ankle brachial index (abi) has proved a valuable tool in the quantification of cardiovascular risk, and perhaps the most promising when compared with other methods. it is easy, cheap, fast and feasible in office care, with a great acceptance between patients and small intra and inter observer variability. despite strong evidence of the utility of abi as a tool in assessing cardiovascular risk, there are no data about the use of abi in other patients referred for non vascular surgery, which constitutes the majority of operations performed worldwide. objectives: to evaluate the use of abi as a predictor of cardiovascular events in patients undergoing non-cardiac and non-vascular surgery and its applicability as a tool in the reclassification of patient risk groups established by guidelines for perioperative evaluation. methods: 300 moderate to high risk patients referred for non-vascular and non-cardiac will be included. data about risk factors, signs and symptoms, physical examination and treatment used will be collected before surgery. the abi will be measured and the patient will be monitored for 30 days to the detection of cardiovascular events: death from any cardiovascular causes, unstable angina, nonfatal myocardial infarction, isolated elevation of troponin, decompensated heart failure, cardiogenic shock, stop nonfatal heart failure, pulmonary edema, stroke and lower limb ischemia. postoperative electrocardiogram, total creatine kinase, mb fraction and troponin i will be measured daily until 3º day and whenever clinically indicated.


Eligibility criteria:
inclusion criteria: * patients aged 18 or older, moderate to high risk by revised cardiac risk and the modified cardiac risk index undergoing non-cardiac and non-vascular surgery will be referred for the study. exclusion criteria: * patients with atrial fibrillation, aortic regurgitation, low risk of cardiovascular complications by the revised cardiac risk and the modified cardiac risk index and those referred for vascular or cardiac surgery.

Keywords: ankle brachial index perioperative care general surgery acute coronary syndromes cardiovascular complications
functional assessment of patients with acute bipolar depression after 8 months of follow-up

Conditions: Bipolar Disorder; Bipolar Depression

Summary: this study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder i or ii (dsm-iv-tr) * acute depressive episode at inclusion exclusion criteria: * inability (in investigator´s opinion) to carry out the follow-up plan * patients participating or having participated within previous 6 months, in clinical trials * mental retardation or any other medical condition affecting cognitive performance

Keywords: bipolar depression subsyndromal symptoms functioning cognitive function
does the bioactive substance in coffee, cafestol, have preventive properties on type-2-diabetes? (acute substudy)

Conditions: Obesity, Abdominal

Summary: acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three ogtts.

the study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing t2d. initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. immediately hereafter an ogtt commences with ingestion of a 75 g glucose solution. in the following 2 hours blood samples are collected at time points 15, 30, 60, 90, 120 and 180 min. the samples will be used for determination of plasma glucose, insulin and cafestol, as well as glp-1 and gip. after a one-week washout period, the subject will undergo the same set-up again, however now with the different dosage of cafestol or placebo. the process is repeated for three weeks until every subject has undergone both interventions and the placebo.

Eligibility criteria:
inclusion criteria: 25 \ 102 cm (men) / 88 cm (women) exclusion criteria: * type 2 diabetes (hba1c \> 48 mmol/mol) or in treatment with antidiabetic drugs * pregnancy * planned pregnancy * breastfeeding * significant comorbidity expected to unable the subject from completing visits
cross-section band ligation versus stepladder band ligation of esophageal varices

Conditions: Esophageal Varices

Summary: the goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis. researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival. participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. patients will be randomly assigned to endoscopic band ligation (ebl) either by cross-section or stepladder techniques every two to four weeks until eradication. after eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. for a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from ebl treatment.


Eligibility criteria:
inclusion criteria: * aged \>18 years. * cirrhotic patients. * endoscopic evidence of medium/large-sized esophageal varices. exclusion criteria: * history of variceal bleeding or previous primary prevention of varices. * portal vein thrombosis or previous porto-systemic shunts as tips. * patients on drugs affecting portal pressure (beta blockers, nitrates). * advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia. * patients with severe respiratory diseases (copd, bronchial asthma). * uncontrolled diabetes mellitus. * renal impairment. * hepatocellular carcinoma. * allergy to carvedilol. * pregnancy or lactation.

Keywords: band ligation esophageal varices prophylaxis
fractal analysis method in periodontal disease

Conditions: Periodontal Diseases

Summary: in this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method.

background: it is very difficult to objectively evaluate the negative changes in bone structure due to periodontitis. the present study was aimed to evaluate the trabecular bone changes between healthy individuals and periodontitis patients by fractal dimension analysis on digital panoramic radiographs. method: the study included 50 periodontally healthy individuals (control group), 50 individuals with stage 1 periodontitis (s1-p group), 50 individuals with stage 2 periodontitis (s2-p), and 50 individuals with stage 3 periodontitis (s3-p), a total of 200 individuals were included. the fractal dimension (fd) value of the trabecular bone in the interproximal space between mandibular first molar and second premolar tooth roots was evaluated using image j program. the mean fractal dimension values of the two regions were calculated by box counting method.

Eligibility criteria:
inclusion criteria: * 18-65 years old * getting a diagnosis of stage 1,2 and 3 periodontitis * be diagnosed as periodontally healthy * have no barriers to obtaining radiographs * not having any systemic disease that may affect periodontal status * not smoking and alcohol use * volunteer to participate in the study exclusion criteria: * those who use drugs that can affect bone metabolism * radiographs with poor diagnostic quality * root canal treatment or teeth with periapical lesions in the area of interest * individuals who have suffered a fracture or trauma that affects the anatomy or integrity

Keywords: digital radiography fractal analysis periodontitis
comparing the effects of upper and lower body resistance training on pain sensitivity

Conditions: Healthy

Summary: resistance exercise may immediately lessen the perception of pain. the purpose of this study is compare the effects of an upper body exercise to a lower body exercise on the perception of pain (pressure pain threshold).


Eligibility criteria:
inclusion criteria: * pain free exclusion criteria: * non-english speaking * regular use of prescription pain medications * current or history of chronic pain condition * currently taking blood-thinning medication * any blood clotting disorder * medical conditions known to affect sensation, such as: uncontrolled diabetes or neurological conditions * any contraindication to the application of ice, including: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise * not physically ready to exercise without a medical exam as indicated by the physical activity readiness questionnaire plus (par-q+) * surgery, injury, or fracture within the past 6 months * unable to perform exercise portions of the study * unable to attend three sessions * pregnant
obesity and pediatric multiple sclerosis

Conditions: Multiple Sclerosis

Summary: obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. we already know that obesity is a risk determinant for acquiring ms, yet the impact of obesity on pediatric ms disease expression and course is unknown. this study will evaluate the relationship between obesity, obesity-derived inflammatory mediators, and imaging metrics of ms severity in children. understanding how childhood obesity contributes to ms severity/progression may yield fundamental insights into disease pathobiology - which may thereby lead to effective strategies for halting its progression in its earliest stages.


Eligibility criteria:
pediatric ms subjects will meet below inclusion and exclusion criteria: inclusion criteria: * ability to provide informed consent (or assent for minors) * relapsing-remitting ms diagnosis per 2017 mcdonald criteria * ages ≥ 10 years to ≤ 20 years * diagnosis of ms or first clinical symptom of ms (whichever comes first) within ≤ 36 months from the time of enrollment. exclusion criteria: * progressive form of ms * patients with an active, chronic disease of the immune system other than ms * conditions affecting the central nervous system (cns) white matter (e.g. leukodystrophy) or for whom another condition may better explain imaging abnormalities (e.g. lupus) * myelin oligodendrocyte glycoprotein (mog) antibodies on serologic testing * corticosteroid exposure within 30 days of study enrollment control subjects (aim 2) will meet the below inclusion and exclusion criteria: inclusion criteria: * ability to provide informed consent (or assent for minors) * age-, sex-, \& bmi-matched to pediatric ms subjects (1:1 allocation) * healthy children and young adults from the local communities exclusion criteria: * history of past imaging or neurologic event raising concern for any inflammatory cns process * medical history or previous/current diagnosis consistent with an autoimmune disorder pertaining to any system of the body (e.g. diabetes mellitus type 1, crohn's disease, lupus)

Keywords: pediatric obesity neurodegeneration inflammation
observational study of safety and effectiveness of novomix® 30 for the treatment of diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia, europe, japan and north america. the aim of this observational study is to evaluate the safety and effectiveness while using novomix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. the primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.


Eligibility criteria:
inclusion criteria: * age according to approved label and physician discretion * type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before exclusion criteria: * subjects who previously enrolled in this study * subjects who are unlikely to comply with protocol requirements * hypersensitivity to biphasic insulin aspart or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
an investigation to validate speech perception assessment for adult cochlear recipients using a mobile research app

Conditions: Hearing Loss

Summary: the study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the mobile research app to measure and validate speech perception endpoints in adult cochlear implant recipients.


Eligibility criteria:
inclusion criteria: * adults 18 years of age or older. * uses a hearing device or devices (hearing aid/s and/or cochlear implant/s). * fluent speaker in the language used to assess clinical performance as judged by the investigator. * willing and able to provide written informed consent. exclusion criteria: * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation). * women who are pregnant.
complete digital workflow for construction of full arch implant supported screw retained restoration

Conditions: Prosthesis Durability

Summary: this study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a complete digital workflow to construct full arch implant-supported screw-retained restoration.


Eligibility criteria:
inclusion criteria: * • inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- angel's class i maxillo-mandibular relationship and iv- adequate bone height and width for placement of standard diameter implants. exclusion criteria: * history of drug administration that interfere with bone quality ii- surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.
design and application of airborne visual real-time evaluation system for air medical rescue

Conditions: Medical Emergencies

Summary: this study intends to use ar (augmented reality) smart wearing equipment combined with 4g + satellite information transmission system to achieve two-way real-time information transmission in air-to-ground medical rescue.

investigators are going to add a pair of wearable smart glasses with ar function to the original flight helmet .during the rescue, the doctors are asked to wear the special helmet, through the device's camera system and headset, investigators can obtain graphics and sound of the helicopter cabin .at the same time, it also receives the historical data of patients and real-time diagnosis as well as rescue guidance from the ground medical institutions. in short ,it can not only transmit the patient's information in the cabin to the ground medical institutions in real time, but also transmit the rescue plan of the ground medical experts to the rescue helicopter in real time to ensure the safety of patients in transit ,which will save the time for medical staff to hand over after landing and reduce errors. at present, most of the airborne information exchange systems in air medical rescue in china focus on the internal use of the army, which are incompatible with the medical information systems of most hospitals on the ground. moreover, these systems can only achieve limited information transmission, and can not delivery rescue scene images in real time. civil air medical rescue conditions are relatively backward, most of them rely on 2g/3g/4g mobile communication technology, which can lead to failure in case of bad weather or sudden major disasters, and bring great security risks to patients in air medical rescue. if the airborne visual real-time evaluation system can be successfully completed, it will be popularized and applied in chinese airborne first aid alliance, and eventually a standardized airborne medical rescue information management system will be formed. furthermore, a three-dimensional rescue system for civil airborne medical rescue will be built to reduce the potential safety hazards of patients in airborne medical rescue, and to enhance the rapid response ability and organization of medical institutions.

Eligibility criteria:
inclusion criteria: * critically ill patients who require air transportation support; * patients informed consent and sign the informed consent form exclusion criteria: * none

Keywords: air medical rescue satellite information transmission augmented reality
prospective study for molecular biomarkers and spatial transcriptomics of stage iva nasopharyngeal carcinoma

Conditions: Stage IVA Nasopharyngeal Carcinoma

Summary: this clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in stage iva nasopharyngeal carcinoma.

primary endpoint: evaluation of the major pathological response of stage iva nasopharyngeal carcinoma patients. secondary endpoint: evaluation of failure-free survival and overall survival of stage iva nasopharyngeal carcinoma patients. outline: this is a prospective observational study. patients of stage iva nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. tumor tissue specimens are obtained from patients when recruited and disease progression. the samples are analyzed for biomarkers and spatial transcriptomics. the biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death). the analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in stage iva nasopharyngeal carcinoma. this will lead to the definition of risk groups and stratification of patients and will help in precision medicine of stage iva nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed stage iva nasopharyngeal carcinoma 2. no evidence of distant metastasis (m0) 3. written informed consent exclusion criteria: treatment with palliative intent

Keywords: nasopharyngeal carcinoma biomarker spatial transcriptomics
a study of opc-262 in patients with type 2 diabetes

Conditions: Diabetes Type 2

Summary: the purpose of this clinical study is to evaluate the superiority of the efficacy of opc-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of opc-262 to placebo.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes patients with hba1c above 6.5% and below 10% 2. patients who are capable of giving informed consent 3. patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) exclusion criteria: 1. patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus 2. patients with a medical history of diabetic coma 3. patients with poorly-controlled hypertension 4. patients with heart failure 5. patients with a complication of active hepatitis or hepatic cirrhosis 6. patients undergoing treatment of glomerular diseases other than diabetic nephropathy 7. patients with a history or complication of malignant tumor
efficacy of risedronate in patients with painful periprosthetic resorption of the hip prothesis

Conditions: Prosthesis Loosening

Summary: this is an experimental study, prospective, comparative. this clinical trial is randomized and double-blind, residronate versus placebo. the study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. the first group receives active drug (risedronate 75mg) and the second a placebo. patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month. evaluations are planned evry 6 months.


Eligibility criteria:
inclusion criteria: * male or female subjects, 18 years of age or older. * written informed consent * subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis) * painful aseptic loosening * subject has pain 4 or greater on a 10 point visual pain rating scale * for subject woman of reproductive age, they must use reliable method(s) of contraception and/or abstinence, for the duration of therapeutic product exposure. exclusion criteria: * subjects with septic loosening of hip prosthesis . subjects with bilateral disease * subjects with implant mobility associated with pre-operative and intraoperative loosening * subjects under anti-osteoporotic treatment * subjects having stopped a biphosphonate traetment for less than one year * subjects with known allergy or sensitivity to any of the components in the study medication. * subjects with hypocalcemia * females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study. * subjects with severe kidney failure ( creatinine \< 30 ml/min)). * subjects participation in another research study * subjects with previous osteonecrosis of the jaw