Kornimate/medical-research-clean huggingface dataset:
buprenorphine, clonidine, and dexamethasone on duration of brachial plexus blocks for upper extremity surgery

Conditions: Pain, Postoperative

Summary: the goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. the main question it aims to answer is whether there is a difference between interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

this study will be a prospective randomized single-blinded clinical trial. patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. a total of 120 patients will be recruited to participate. patients will be randomized via a 1:1 ratio to either the interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or interscalene block alone group the null hypothesis of this research study is that there will be no significant difference in morphine requirements between the interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * patients undergoing shoulder arthroscopy * patients willing to participate and sign informed consent exclusion criteria: * severe copd/other contraindication to general anesthesia * patient with a weight of less than 60 kg * dementia, not alert or oriented to person, place, or time * chronic pain patient with daily opioid use at home. * patient with allergy to local anesthetics * patient refusal * total shoulder arthroplasty * concomitant pain in different area from operative site. * pregnancy * patient with active infection on the injection sites for the blocks * patients unable or willing to understand or comply with the study protocol

Keywords: buprenorphine clonidine dexamethasone brachial plexus blocks pain shoulder surgery
a study of hr19024 in subjects with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: to evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of hr19024 injection in the treatment of advanced solid tumor


Eligibility criteria:
inclusion criteria: 1. ecog performance status 0 or 1 2. histologically confirmed advanced solid tumor 3. life expectancy of greater than or equal to (\>=) 12 weeks 4. at least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (recist 1.1) 5. able and willing to provide a written informed consent exclusion criteria: 1. subjects with unresolved toxicity （\> ctcae g1）of prior therapy at the time of enrolment 2. subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
study to develop a prediction model to understand the effect of low-dose aspirin on cancer that develops in the colon and/or the rectum, diseases that affects the heart or blood vessels and safety outcomes in european countries. the study is also called peacos model eu

Conditions: Colorectal Cancer; Cardiovascular Disease; Bleeding

Summary: in this study researchers want to learn more about the effect of low-dose aspirin on cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus), diseases that affects the heart or blood vessels and safety outcomes. study will focus on two groups of adults aged 50-59 and 60-69 years having an increased risk of heart and/or blood vessel disease who are taking either low-dose aspirin or no low-dose aspirin for heart and/or blood vessel disease prevention. the model will be based on information publicly available either on government organization websites or in scientific journals. based on these data researchers will focus in a first step to build a model of 2 million adults (1 million for each age group) for the uk population and in a second step, the model will be modified for use with other european countries, to reflect the epidemiology and guidelines for aspirin use in these countries.

observational study model is selected as "other" - reason: individual-level state transition model simulating the number of events of crc, cvd, safety events and deaths in hypothetical cohorts of 1 million adults aged 50-59 years and 1 million adults aged 60-69 years followed for 20 years or till death, whichever comes first. the hypothetical cohorts are reflective of a population eligible for taking aspirin for primary or secondary cvd prevention. time perspective is also selected as "other" - reason: individual-level state transition model built mimicking the uk population using data published in scientific international peer-reviewed journals or published data from government agencies. in a second phase, the model results will be extrapolated to other eu countries, modifying the model parameters to reflect the other eu countries epidemiology.

Eligibility criteria:
inclusion criteria: - european populations (uk and other european countries) of adults aged 50-59 and 60-69 years eligible for using aspirin for primary or secondary cvd prevention. subjects are eligible when they have no contra-indications, and are at increased risk of cvd (primary prevention) or have suffered from a previous cvd event exclusion criteria: - none
effect of root planing on surface topography.

Conditions: Chronic Periodontitis

Summary: in a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing with piezoelectric ultrasonic scraper \[pu\]; or 4) root planing with vertically oscillating ultrasonic device \[vou\]. post-treatment, the teeth will be extracted and their topography analyzed in 124 observations with white light confocal microscopy, measuring the roughness parameters rp, rv, rt, ra, rq, rku, and rsk.


Eligibility criteria:
inclusion criteria: * patients undergoing programmed tooth extraction for chronic advanced periodontitis. exclusion criteria: * patients with no advanced periodontitis or patients that refused the treatment.
norepinephrine to prevent hypotension in ceasrean delivery

Conditions: Hypotension; Cesarean Section Complications

Summary: this study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at menoufia university hospital.

informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee. all subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile. standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring after arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ecg leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ecg electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection. 10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr. patients will be then placed in sitting position. after skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at l3-l4 or l4-l5. the patient will be then returned to the left-tilted supine position. the study drug regimen will be started immediately after intrathecal injection.

Eligibility criteria:
inclusion criteria: * asa i \& ii * non laboring * normotensive * elective cesarean delivery under spinal anesthesia. * baseline systolic blood pressure 90-140 mm hg exclusion criteria: * known fetal abnormality. * preexisting or pregnancy-induced hypertension. * known cardiovascular or cerebrovascular disease. * thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia. * weight \ 100 kg, height \ 180 cm. * inability or refusal to give informed consent

Keywords: hypotension norepinephrine
pharmacoeconomic study assessing the cost of chronic hepatitis c treatment with peginterferon alfa-2b (pegintron) and ribavirin (rebetol) in the czech republic (study p04588)(completed)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to evaluate the costs associated with peginterferon alfa-2b (pegintron) plus ribavirin (rebetol) treatment for chronic hepatitis c in the czech republic. only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. the study will also evaluate the correlation between hepatitis c virus (hcv) therapy-related costs with ribavirin dosing and participant history.


Eligibility criteria:
inclusion criteria: * participants with chronic hepatitis c * at least 18 years old * eligibility determined based on the diagnosis and medical judgment only. exclusion criteria: * none
optimization of parameters of subthalamic nucleus stimulation

Conditions: Parkinson Disease

Summary: deep brain stimulation of the subthalamic nucleus is an effective treatment for parkinson's disease. the analysis of cerebral signals of the subthalamic nucleus by local field potentials, provides one of the main electrophysiological markers of the success of the stimulation. this marker can be used to evaluate new paradigms of stimulation. so far, little studied, the temporal characteristics of the stimulation are very important in the effectiveness of the stimulation of the subthalamic nucleus, in parkinson's disease. the first objective (study i) is to compare the effectiveness of the stimulation when it is applied with biphasic symmetrical pulses and when applied with the standard pulses applied so far. the second objective (study ii) is to see if, by applying pseudo-random time intervals between each stimulation pulse, if it would be possible to improve the efficiency and to limit the side effects of the stimulation. the third objective (study iii) is to evaluate the electrophysiological changes of the subthalamic nucleus caused by the general anesthesia, in the anticipation of the realization of the surgery of the stimulation of the subthalamic nucleus under general anesthesia.

study i and ii: patients who participate undergo pulse generator change under sedation. four sets of stimulation parameters will be compared. the efficacy of every set will be measured on induced changes in lfp recorded from the stn electrodes. lfp will be compared between before, during and right after each stimulation conditions. the stimulation order will be randomized. all other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5ma) . study iii: patients who participate undergo their first pulse generator implantation, performed under general anesthesia because of wire tunnelisation. the depth of anesthesia will be documented, recording the bis spectral analysis index. the difference in spectral amplitude density of lfp, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the bis index at the time of 2 minutes recordings.

Eligibility criteria:
inclusion criteria: * patients suffering from parkinson's disease, who must undergo surgery for the replacement of their neurostimulator (under sedation) or for the first positioning of it * capacity of discernment * informed signed consent exclusion criteria: * health considerations in regard to adding 13' in surgery room (e.g. pain or incomfort).
comparison of wide-field retinal imaging

Conditions: Retinal Disease

Summary: fundus imaging has become an integral tool in retinal diagnosis. although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered. ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown. in austria, there are two different wide-field imaging systems available. the first device on the market was the optos (optos plc, dunfermline, uk) and several years later the clarus 500 (carl zeiss, meditec ag, jena, germany) was introduced.

while both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment. aim: to compare two ce-marked imaging systems concerning the extent of retinal periphery area viewing. we would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients. fundus photography will be performed using two ultra-wide-field imaging systems (optos, daytona, optos plc, dunfermline, uk and clarus, 500 carl zeiss, meditec ag, jena, germany), performed by the same investigator. all images with sufficient quality will be exported and saved to hard-disk. the difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into photoshop cs6 image-editing system (adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.

Eligibility criteria:
inclusion criteria: * patient over 21 years old * myopic (at least -5.00dsph), hyperopic (over +3.00dsph) and emmetropic patients * written informed consent prior to any study specific action. exclusion criteria: * extensive cataract or severe corneal scaring that would affect image quality * fixation problems, nystagmus * pregnancy- for women in reproductive age a pregnancy test will be performed.

Keywords: retinal imaging wide field
effect of calories and fat content on the pharmacokinetics of lurasidone hcl

Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Summary: the objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of lurasidone hcl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Eligibility criteria:
inclusion criteria: * male and female 18 to 65 years of age * bmi \>= 19.5 and \<= 37 kg/m2 * no clinically relevant abnormal laboratory values exclusion criteria: * history or presence of renal or hepatic insufficiency * participated in a clinical trial in the past 30 days * use of con meds that prolong the qt/qtc taken within 14 days prior to study drug administration
sdm for stroke prevention in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

the goal of this study is to determine the extent to which the anticoagulation choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.

Eligibility criteria:
clinician inclusion criteria: • all clinicians (mds, np/pas, pharmds) that are responsible for the modality of anticoagulation in eligible af patients at participating sites, without exclusion patient inclusion criteria: * ≥ 18 years of age * chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (cha2d2-vasc score ≥ 1, or 2 in women) * able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent patient exclusion criteria: • clinician indicates that patient is not a candidate for a discussion about anticoagulation medication

Keywords: afib atrial fib shared decision making aid af
feasibility and usability of a virtual reality system

Conditions: Autism Spectrum Disorder; Intellectual Disability

Summary: intellectual disability (id) and autism spectrum disorder (asd) are often co-occurring neurodevelopmental disorders that require composite intervention. however, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. the virtual reality rehabilitation system (vrrs) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. the use of vrrs offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with asd and id, according to the criteria of the diagnostic and statistical manual of mental disorders (dsm-5); * age between 6 and 40 years; * cognitive level \<65 intellectual quotient * signed informed consent exclusion criteria: * subjects without diagnosis of asd and id, according to the criteria of the diagnostic and statistical manual of mental disorders (dsm-5); * age not between 6 and 40 years; * cognitive level \>65 intellectual quotient * unsigned informed consent
evaluating the efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan

Conditions: Hypercholesterolemia; Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan in patients with primary hypercholesterolemia and essential hypertension.

this trial is a phase 3 study to evaluate efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan in patients with primary hypercholesterolemia and essential hypertension. in "rosuvastatin/ezetimibe+telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "rosuvastatin/ezetimibe+telmisartan" for 8 weeks. in "rosuvastatin/ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "rosuvastatin/ezetimibe" for 8 weeks. in "telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "telmisartan" for 8 weeks.

Eligibility criteria:
inclusion criteria: * signed informed consent * subjects with hypertension and hyperlipidemia exclusion criteria: * patient with known or suspected secondary hypertension * other exclusions applied
safety and immunogenicity of two intradermal rabies vaccine regimens administered with and without human rabies immunoglobulin in subjects ≥ 1 years of age

Conditions: Rabies Infection

Summary: demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.


Eligibility criteria:
inclusion criteria: 1. healthy males and females ≥ 1 years of age 2. individuals/ individual's parents or legal guardians who have given written consent 3. individuals in good health 4. individuals who can comply with study procedures exclusion criteria: 1. behavioral or cognitive impairment or psychiatric disease. 2. unable to comprehend and to follow all required study procedures for the whole period of the study. 3. history of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study. 4. individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy. 5. individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. 6. known or suspected impairment of the immune system (including but not limited to hiv, autoimmune disorders, immunosuppressive therapy as applicable). 7. female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry. 8. female of childbearing potential, refusal to use an "acceptable birth control method" through day 50. 9. female of childbearing potential, with a positive pregnancy test prior to enrollment. 10. received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks. 11. allergic to any of the vaccine components. 12. allergic to any of the human rabies immunoglobulin components. 13. contraindication or precaution against rabies vaccination. 14. contraindication or precaution against man rabies immunoglobulin administration. 15. planning to receive anti-malaria medications (e.g. mefloquine) 14 days prior to day 1 vaccination through day 50. 16. participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 17. received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. 18. body temperature ≥ 38.0°c (≥ 100.4°f) within 3 days of intended study vaccination. 19. received rabies vaccines or rabies immunoglobulin or have been exposed to rabies. 20. part of the study personnel or immediate family members of study personnel conducting this study. 21. current or history of drug or alcohol abuse within the past 2 years.

Keywords: rabies vaccines intradermal human rabies immunoglobulins