Kornimate/medical-research-clean huggingface dataset:
clinical study to investigate the pk profiles and safety of ckd-385 in healthy volunteers under fasting conditions

Conditions: Cardiovascular Diseases

Summary: clinical study to investigate the pharmacokinetic profiles and safety of high-dose ckd-385 in healthy volunteers under fasting conditions

a randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose ckd-385 in healthy volunteers under fasting conditions

Eligibility criteria:
inclusion criteria: 1. healthy adult aged more than 19 at the time of screening 2. those who had 18.0kg/m² ≤ body mass index (bmi) \< 30.0kg/m² # bmi=weight(kg) / height(m)² 3. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination. 4. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ecg results at screening. 5. those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations. 6. those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product. exclusion criteria: 1. those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth). 2. those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug. 3. those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening. 4. those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs. 5. those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products. 6. those who have taken any drugs that may affect the clinical trial within 10 days. 7. those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products. 8. those who are deemed insufficient to participate in this clinical study by investigators.
acetyl-l-carnitine in the treatment of septic shock

Conditions: Septic Shock

Summary: this placebo-controlled study investigates acetyl-l-carnitine in the treatment of septic shock requiring vasopressors.

this is a cross-over study which infuses alc for 12 out of 18 hours (and placebo the other 6). patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Eligibility criteria:
inclusion criteria: * documented or presumed infection * shock requiring vasopressors exclusion criteria: * dialysis * hepatic failure * seizures

Keywords: septic shock acetyl-l-carnitine
pilot trial to evaluate problem solving therapy and apple watch for college students

Conditions: Alcohol Use Disorder

Summary: the goals of this pilot trial are to test the preliminary efficacy of problom-solving therapy (pst)-apple watch in a 2-arm pilot randomized control trial (rct), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.

the aims of this study are (1) to test feasibility \& acceptability of screening for aud symptoms/alcohol misuse and recruitment among college students, and (2) to test preliminary efficacy of pst-apple watch in a 2-arm pilot randomized control trial (rct).

Eligibility criteria:
inclusion criteria: * male and female college students aged 18-25 yr * english-speaking * current alcohol use more than or equal to 2 days/week via phone screening * completion of audit screening and meet criteria for (past year) mild, moderate or severe aud during audadis-5 interview * completion of written informed consent * interested in cutting back alcohol intake or changing his/her drinking * baseline screening study visit exclusion criteria: * participation in past 6 months in aud or substance use treatment * current use of medications used to treat aud (e.g., naltrexone) * lifetime diagnostic and statistical manual of mental disorders (dsm)-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder * current use of psychoactive drugs * not currently enrolled in college * not interested in cutting back alcohol intake or changing his/her drinking * pregnancy or intention to become pregnant
comparative physiologic technology study

Conditions: Peripheral Arterial Disease

Summary: this study is designed to test two hypotheses: 1. the padnet+ testing system produces clinically equivalent results as the parks flo-lab testing system in a group of patients referred for evaluation of pad of the limbs when performed by a registered vascular technologist (rvt). 2. the padnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the padnet+ system but are not vascular technologists nor hold the rvt certification.


Eligibility criteria:
inclusion criteria: * all patients referred to the mgh vascular labs for diagnostic testing for pad exclusion criteria: * none
effects of navigation versus conventional total knee arthroplasty on the levels of inflammation markers

Conditions: Arthroplasty Complications; Inflammatory Response

Summary: total knee arthroplasty (tka) is a well-established modality for the treatment of advanced knee osteoarthritis with high satisfaction rate. however, the traditional cutting jigs for distal femur cutting inevitably violates the medullary canal of femoral bone. the process of intramedullary reaming for the insertion of distal femur cutting jigs stimulated the dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or cardiac stress perioperatively. there are emerging refinements aiming to reduce the insult to the medullary canal of the distal femur as well as to improve the prosthetic alignment, such as navigation assisted tka or robotic surgery. in addition to better prosthetic alignment, computer-assisted navigation tkas also mitigate perioperative blood loss and systemic emboli. the publication previously published by the investigators showed that navigation tkas can lead to lesser extent of elevation of endothelial injury markers than the traditional tkas. however, the detrimental effects of intramedullary reaming seem to be multi-dimensional and the whole picture has not been elucidated clearly at present. previous studies have shown that operative trauma can trigger marked immune responses. operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory response, with 80% of the leucocyte transcriptome being affected. most studies of hip or knee surgery found that operation-triggered immune reactions are associated with postoperative recovery, infection, and even mortality. the navigation tkas avoid the process of intra-medullary reaming, which is the mandatory part of conventional tka for the distal femur cutting. the investigators hypothesize that the reaming process may exert substantial inflammatory response, which can be manifested by higher level of inflammatory markers in the serum and hemovac drainage samples obtained from the participants undergoing conventional tkas.


Eligibility criteria:
inclusion criteria: * end stage knee oa necessitating tkr surgeries exclusion criteria: * autoimmune diseases, malignancies, previous knee surgery or post-traumatic arthritis
chronic remote ischemic preconditioning as a complement to conventional prenatal care for preeclampsia

Conditions: Preeclampsia

Summary: pre-eclampsia is a disease specific to pregnancy that affects 3-5% of women. it is defined by the appearance of high blood pressure after 20 weeks of amenorrhea associated with the presence of proteins in the urine, dysfunction of organs such as the liver, kidneys, lungs or brain, or dysfunction of the placenta. the cause of this disease is still unclear but it would most likely be a placental origin. pre-eclampsia is a progressive disease that can lead to important complications. to date, there is no treatment for pre-eclampsia other than childbirth and more particularly placental delivery. nevertheless, it is possible in some cases to stabilize arterial hypertension and thus to hope for a prolongation of the pregnancy. our research project aims to study the effect of preconditioning on blood pressure. preconditioning consists of using a blood pressure cuff and inflating it on the upper limb -like during a standard blood pressure measurement- for several minutes followed by a rest period in order to create "ischemia-reperfusion" periods. this technique would allow the release of beneficial substances into the bloodstream that would lower blood pressure. this method has been used for several years in different specialties and has produced good results on the heart, kidneys, lungs and brain. with this technique we hope to stabilize or even reduce blood pressure in cases of pre-eclampsia and thus prolong the pregnancy.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age between 24 0/7 and 36 6/7 weeks' gestation * hospitalization for non-severe pre-eclampsia (non-severe hypertension = systolic blood pressure between 140 and 160mmhg, diastolic blood pressure between 90 and 110mmhg associated with one of these: proteinuria \>=300mg/24h/thrombocytopenia 100-150g/l/central symptoms such as headache responding to standard analgesics/hyperreflexia without clonus/decreased fibrinogen/haptoglobin \<0.1/utero-placental dysfunction with iugr and/or umbilical doppler class ii) * maternal age \>18 years * good comprehension of french allowing easy understanding of the information protocol and the consent form exclusion criteria: * chronic hypertension * renal disease * pre-pregnancy diabetes * autoimmune disease (sapl, sle, sjögren) * severe pe (systolic blood pressure \>160mmhg, diastolic blood pressure \>140mmhg, hepatic cytolysis at twice the norm, right hypochondrium or epigastric pain, central symptoms such as clonus or headache resistant to usual treatment or disturbed consciousness, thrombocytopenia \ 97 micromol/l) * suspected fetal anomaly or malformation * hellp syndrome * eclampsia attack * pathological fetal monitoring * known maternal upper limb vascular anomaly * severe maternal cardiac pathology * maternal history of deep vein thrombosis of the upper limb

Keywords: preconditioning
comparison between levofloxacin and prulifloxacin, in internal medicine patients with acute exacerbation of copd

Conditions: COPD Exacerbation

Summary: the primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). the effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of copd (sputum purulence, sputum volume, cough, dyspnea, fever)

the aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of copd, previously treated unsuccessfully with other antibiotics, and hospitalized in internal medicine. these patients reflect the reality of patients admitted to internal medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.

Eligibility criteria:
inclusion criteria: * - presence of purulent sputum documented by colorimetric assay (allegra et al., resp med 2005), plus at least two of the following signs-symptoms * increased cough * increased dyspnea * increase in sputum volume appeared at least 3 days * previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital * ≥ 60 years * fev1 \<80% and ≥ 30% and ratio fev 1 / fvc \<70% * chest x-ray negative for inflammatory infiltrates * informed consent exclusion criteria: * asthma * pulmonary neoplasms * a history of allergy or hypersensitivity to quinolones * impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system * a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months) * history of tendinopathy * note or severe renal impairment creatinine\> than twice the upper limit of the normal range or hepatic impairment (ast and / or alt\> twice the upper limit of the normal range) * patients with sepsis, tuberculosis or other infections in other organs or systems * cystic fibrosis * patients with inherited tolerance to intolerance, lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase * pregnant or breastfeeding * drug or alcohol addiction * experimental concomitant treatment with other drugs

Keywords: copd exacerbation fluoroquinolones,
a study comparing doxycycline and levofloxacin for treating copd exacerbations

Conditions: COPD

Summary: this study will include patients with chronic obstructive pulmonary disease (copd) who present with an acute exacerbation. participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. the aim is to compare how effective each antibiotic is in improving symptoms after 2 days of treatment.

this randomized controlled trial will evaluate the effectiveness of two antibiotics-doxycycline (a tetracycline) and levofloxacin (a fluoroquinolone)-in the treatment of acute exacerbations of chronic obstructive pulmonary disease. participants will be assigned to one of the two treatment groups and will receive either doxycycline 100 mg twice daily or levofloxacin 500 mg once daily for 5 days. the primary outcome is clinical cure. this will be evaluated 2 days after completion of antibiotic therapy, based on symptom resolution and laboratory markers.

Eligibility criteria:
inclusion criteria: * diagnosed cases of copd exacerbation of copd able to provide written consent no anti biotic taken with in past 4 weeks exclusion criteria: * hypersensitivity to any drugs pneumonia evidence on xray/ hrct chest any other pulmonary condition e.g asthma pregnancy/breast feeding taking treatment for other active infections

Keywords: copd
a triple combination antiviral coronavirus therapy (triact) for covid-19

Conditions: SARS-CoV Infection; Covid19

Summary: new outpatient treatments for covid-19 are urgently needed. there is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. the purpose of this trial is to evaluate the efficacy of nitazoxanide (ntz), ribavirin (rbv) and hydroxychloroquine (hcq) versus placebo in participants with proven sars-cov-2 infection the study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. the purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. participants will be actively followed for 28 days.

participants will be randomized into one of two treatment plans * triple combination: * nitazoxanide (500 mg po bid for day 1and then 500 mg bid for 4 days) * ribavirin (600 mg po bid for day 1and then 400 mg bid for 4 days) * hydroxychloroquine sulfate (400 mg po bid for day 1 and then 200 mg bid for 4 days) * no active medication: * placebo administered according to the above schedule viral load (qpcr via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. immune status will be determined by antibody testing of blood collected at baseline and day 28. symptom questionnaires will be completed daily for 10 days and day 28.

Eligibility criteria:
inclusion criteria: * documented sars-cov-2 infection by qpcr assay performed within the past 7 days exclusion criteria: * covid-19 symptoms requiring hospitalization * po2 \< 92% * short of breath at time of enrollment * retinal eye disease * known glucose-6 phosphate dehydrogenase (g-6-pd) deficiency * known chronic kidney disease, stage - 5 or receiving dialysis * current use of: * class 3 aad (amiodarone, dronaderone, dofetilide, sotalol) * class 1a aad (procainamide, quinidine, disopyramide) * flecainide * ssri: citalopram (celexa), escitalopram (lexapro) * chlorpromazine * cilostazol (pletal) * donepezil (aricept) * droperidol * fluoconazole * methadone * ondansetron (zofran) * thioridazine * macrolides (clarithromycin, erythromycin) * fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) * tamoxifen * pregnancy or women who are breast feeding * inability to tolerate oral medications * allergy or prior adverse reaction to either hydroxychloroquine sulfate, ribavirin, or nitazoxanide * allergy to adhesives * qtc interval \> 450 msec for men and women * history of torsade de pointes vt or prior cardiac arrest or congenital long qt interval * non-english-speaking
peri-implant disease perception before and after non-surgical peri-implant therapy

Conditions: Peri-implant Mucositis; Peri-Implantitis

Summary: the present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. using validated psychometric tools, including the brief illness perception questionnaire (brief-ipq) and the oral health impact profile-14 (ohip-14), the study evaluates patients at baseline and three months after therapy. the study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 80 years * diagnosis of peri-implant disease requiring non-surgical therapy * presence of at least one dental implant loaded for a minimum of one year * history of periodontitis * good general health * ability to provide written informed consen exclusion criteria: * pregnant or lactating individuals * inability to perform basic oral hygiene procedures * inability to understand or complete study questionnaires

Keywords: oral health impact profile 14 brief-illness perception questionnaire non-surgical peri-implant therapy
effect of vitamin d supplementation on muscular strength, musculoskeletal pain and headache

Conditions: Vitamin Deficiency

Summary: the primary aim of the present trial is to study the effect of daily vitamin d supplementation on muscular power and force among non-western immigrants living in oslo, norway, and secondarily to study the effect of musculoskeletal pain and headache. the investigators have also prespecified a number of additional research questions about anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney function, which because of multiple comparisons should be interpreted with caution unless the statistical evidence for an effect is very strong.

vitamin d deficiency is a widespread public health problem among immigrants from non-western countries in norway. as a background for preventive strategies it is important to have best possible knowledge about health consequences of poor vitamin d status, and in this respect much is lacking. the investigators will aim to study the effect of vitamin d supplementation on muscular strength , musculoskeletal pain and headache among non-western immigrants in norway with background from middle east, africa and south asia. in addition the intervention gives us the opportunity to study the effect of vitamin d on indicators of other important health issues including anemia, diabetes , lipids, inflammation, metabolism and bone health. the study will also contribute with insight on how to achieve a high compliance. this is of interest in a broader context as poor compliance has been experienced as a problem in primary health care among immigrants with poor vitamin d status. the study is a randomized, double blinded, placebo-controlled trial which compares two doses of vitamin d supplements, 400 iu and 1000 iu, with placebo and the tablets will be taken daily in a period of 4 months. three muscle strength tests will be used, and they will be performed before and after the intervention: counter movement jumps, chair rising and handgrip. level and location of musculoskeletal pain and headache will be recorded at baseline and at end of the study. a blood sample will be collected from the study subjects at baseline and after 4 months. the level of vitamin d and markers of anemia, metabolism and bone turnover, inflammation, diabetes, lipids and kidney function will be measured.

Eligibility criteria:
inclusion criteria: * male and female between 18 - 50 years old * immigrants with background from middle east, africa and south asia. exclusion criteria: * daily use of vitamin d supplementation and frequently use of artificial uv light exposure. * pregnancy * malabsorptive disorders * fracture in the leg /arm within the preceding 6 months. known osteoporosis * tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone. * regular use of medication that interfere with vitamin d/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates, * regular use of strong pain killers. * medication for diabetes
video-assisted instruction in type 2 diabetes patients

Conditions: Education, Patient

Summary: the aim of the study of examine the effect of video-assisted instruction on type 2 diabetes patients' insulin treatment self-management and insulin administration skills. the research will be conducted as a single group pre-test post-test quasi-experimental study. the sample of the study will be consisted of 50 patients with type 2 diabetes. before the training, the patients will be self-injected a dose of insulin. after giving verbal training, the patients will watch a video recording of insulin treatment and administration. the author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.

the aim of the study of examine the effect of video-assisted instruction on type 2 diabetes patients' insulin treatment self-management and insulin administration skills. the research will be conducted as a single group pre-test post-test quasi-experimental study. the sample of the study will be consisted of 50 patients with type 2 diabetes. before the training, the patients will be self-injected a dose of insulin. after giving verbal training, the patients will watch a video recording of insulin treatment and administration. the author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.

Eligibility criteria:
inclusion criteria * 18-65 years * no hearing or communication problems * self-injecting insulin exclusion criteria * health care professionals * chronic complications * pregnant

Keywords: self-management type 2 diabetes mellitus video-assisted instruction