Kornimate/medical-research-clean huggingface dataset:
prevention of infections in cardiac surgery (pics) prevena study

Conditions: Surgical Site Infections

Summary: this vanguard study will be conducted at two study sites in canada. it is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (prevena) versus standard wound dressing to reduce chest wound infections.

despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. the best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. a large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. the proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.

Eligibility criteria:
inclusion criteria: - ≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies) exclusion criteria: * on systemic antibiotics or with an active bacterial infection at the time of surgery * patients previously enrolled in this trial * patients known to be colonized with methicillin-resistant s. aureus (mrsa)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of prevena * participation in other studies that may interfere with this trial

Keywords: negative pressure wound management system open-heart surgery antibiotic prophylaxis surgical site infection
assess the feasibility and efficacy of the collarx® bupivacaine implant laparoscopic inguinal or umbilical herniorrhaphy

Conditions: Hernia; Postoperative Pain

Summary: this study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following laparoscopic inguinal or umbilical herniorrhaphy.

inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the united states (us) undergo the procedure annually.common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection. bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. collagen is a protein that is found in all mammals. the collarx bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. when inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. the high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. this open-label study will assess pain intensity after surgery in patients who receive the collarx bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.

Eligibility criteria:
inclusion criteria: 1. man ≥18 years 2. has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal preperitoneal \[tapp\] approach or totally extraperitoneal \[tep\] approach) or laparoscopic umbilical herniorrhaphy to be performed according to standard surgical technique under general anesthesia. 3. willing to use opioid rescue analgesia. exclusion criteria: 1. has a known hypersensitivity to amide local anesthetics, opioids, or bovine products. 2. scheduled for bilateral inguinal herniorrhaphy. 3. undergone a prior herniorrhaphy at the location scheduled for repair. 4. undergone major surgery within 3 months of the scheduled herniorrhaphy.
phase ii study of da-3031(peg-g-csf) in chemotherapy-induced neutropenia

Conditions: Chemotherapy Induced Neutropenia

Summary: this study is to examine which dose of da-3031(peg-g-csf) has similar efficacy and safety compared to daily g-csf in chemotherapy-induced neutropenia.

eligible subjects are randomly assigned to receive once-per-cycle da-3031(peg-g-csf) or daily g-csf(up to 10 days). this study is conducted for 1 cycles of chemotherapy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of stage ii or iii breast cancer 2. age : ≥18, ≤70 3. tac regimen as adjuvant therapy 4. anc≥1,500/mm3, platelet≥100,000/mm3, ecog : 0 or 1 5. creatinine \< 1.5 x uln 6. total bilirubin/ast/alt \< 1.5 x uln, alp \< 2.5 x uln 7. have given a written, informed consent exclusion criteria: 1. received any other investigational drugs within 30 days of informed consent date 2. received systemic antibiotics within 72 hours of chemotherapy into this study or radiation therapy within 4 weeks of informed consent date 3. infective symptom before chemotherapy into this study 4. pregnant or lactating women 5. prior bone marrow or stem cell transplantation 6. other malignancy history within 5 years 7. hiv positive 8. prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date 9. prior chemotherapy

Keywords: peg-g-csf
study to investigate the effect of the a1 agonist capadenoson on ventricular hr in patients with persistent or permanent atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: this trial has the primary goal to show that bay68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.


Eligibility criteria:
inclusion criteria: * male and/or female (without childbearing potential) white patients * history of persistent or permanent atrial fibrillation * 18 to 75 years of age exclusion criteria: * patients with high-risk cardiovascular diseases * stroke or myocardial infarction * relevant pathological changes in the ecg or echocardiography * medication affecting ventricular response in afib

Keywords: atrial fibrillation capadenoson
a study of markers of glucocorticoid effects in patients with addisons disease (doscort)

Conditions: Addison Disease

Summary: doscort is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. patients with addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. blood, saliva, urine, health related quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.


Eligibility criteria:
inclusion criteria: 1. males and females at ages 20-65 years 2. previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. addison´s disease 3. a stable daily glucocorticoid replacement dose for at least 3 months prior to study entry 4. an oral glucocorticoid replacement dose of 15-30 mg hydrocortisone total daily dose 5. if needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry 6. body mass index (bmi) of 20-35 kg/m2 7. ability to comply to the protocol procedures and having signed informed consent to participate in the study exclusion criteria: 1. clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study 2. clinically significant renal dysfunction with a serum creatinine above 150 mmol/l 3. pregnant or lactating women 4. diabetes mellitus 5. systemic infections 6. regular dehydroepiandrosterone (dhea) medication for the past 4 weeks 7. any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility 8. alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator 9. hypersensitivity to the active substance or any excipients used in the study drug of choice 10. any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids 11. any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial

Keywords: biomarker glucocorticoids metabolism
analysis of antihypertensive treatment efficacy

Conditions: Arterial Hypertension

Summary: analysis of antihypertensive treatment efficacy.


Eligibility criteria:
inclusion criteria: * arterial hypertension * intake of atacand before study enrollment exclusion criteria: * hypersensitivity to candesartan or any other ingredient of atacand * liver function impairment and/or cholestasis * severe renal insufficiency (serum creatinine \> 265 µmol/l) * pregnant and lactating women

Keywords: arterial hypertension
pharmacist interventions in rural elderly warfarin patients

Conditions: Atrial Fibrillation; Thrombosis; Cardiac Failure; Hemorrhage

Summary: the primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.


Eligibility criteria:
inclusion criteria: * age ≥65 years * living site of participant outside the city eg. rural site * expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before exclusion criteria: * hospitalization * vegetarianism * patients not able to provide an informed consent * the use of drug that has an x level of clinical significance of interaction with warfarin according to lexicomp interact base

Keywords: pharmacist interventions, warfarin, elderly rural patients
integrated depression care

Conditions: Depression Mild; Depression Moderate; Depression Severe

Summary: the integrated depression care (ideca) programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

the following deliverables apply: 1. development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels; 2. training module for physicians and other care providers in population health management for patients with depression; 3. training module for case managers/integration of a case management function into existing depression service offerings; 4. a patient education module for depression self-management; 5. a financing model for integrated depression care.

Eligibility criteria:
inclusion criteria: * persons between 18-65 * presenting to the general practitioner's office * with depressive symtomatology exclusion criteria: * severe depression warranting direct referral to specialized services inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.
study to assess adverse events and the movement of oral venetoclax tablet through the body of female participants aged 18-75 years with impaired renal function

Conditions: Renal Impairment; Renal Disease

Summary: renal insufficiency is common in participants with blood cancers. the main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (esrd) requiring hemodialysis. venetoclax is an investigational drug being developed for the treatment of various hematologic malignancies. study doctors put the participants in 1 of 2 groups, called treatment arms. each group receives a different treatment. approximately 12 female participants between 18 and 75 years, with body mass index (bmi) between 18 to 42 kg/m2 will be enrolled in approximately 4 sites across the world. participants with normal renal function will receive single dose of oral venetoclax tablet. participants with esrd will receive oral venetoclax tablets just prior to hemodialysis (period 1 day 1) and between dialysis days (period 2 day 1), doses in the two periods will be separated by at least 7 days. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 42.0 kg/m2. * postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). * women of childbearing potential, practicing at least 2 protocol specified methods of birth control that are effective from at least 30 days before starting study drug through at least 30 days after the last dose of any study drug. * group 1 only: must be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ecg) with normal glomerular filtration rate (gfr) at screening. * group 2 only: stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile, and ecg. participant with end stage renal disease (esrd) requiring dialysis on hemodialysis must have been receiving hemodialysis for at least 1 month. exclusion criteria: - participants on a strict vegetarian or vegan diet.

Keywords: renal impairment renal disease end stage renal disease (esrd) venetoclax venclexta
therapeutic effect of direct current stimulation on cognitive function of mild to moderate alzheimer patients

Conditions: Alzheimer Disease

Summary: the current study is planed to compare the efficacy of real (anodal and cathodal) vs sham transcranial direct current stimulation (tdcs) applied over the left dorsolateral prefrontal cortex (dlpfc) on cognitive functions and cortical excitability of patients with alzheimer disease (ad). thirty three with mild to moderate alzheimer's disease (ad) patients (diagnosis of probable ad according to the criteria of the national institute of neurological and communicative disorders and stroke alzheimer disease and related disorders association \[nincds-adrda\] were included in this study) were randomly classified into one of three groups (eleven for each group). the first group received anodal tdcs over left dlpfc and 2rd group received cathodal tdcs on the left dlpfc and the 3rd group received sham tdcs stimulation, daily for 10 consecutive days (5 days/week for 2 weeks). minimental state examination (mmse), psychometric assessment for cognitive functions (mmse, wechsler memory scale, wechsler adult intelligent scale) were assessed before, after 10th sessions, and then after 1 and 2 month. cortical excitability was assessed in both hemispheres before and after the end of sessions. neurophysiological evaluations included resting and active motor threshold (rmt and amt), and cortical silent period (csp). at the time of recruitment, none of the patients taking antidepressants, or neuroleptic, sedative-hypnotic drugs for at least two weeks before the assessment. all participants or their caregivers will give informed consent before participation in the test and after full explanation of the study protocol. outcome: the real group received (anodal and cathodal) tdcs are expected to have more improvement on cognitive functions compared to sham tdcs group. tdcs is considered new adjuvant non pharmacological therapeutic tool for management of ad patients with mild to moderate degree dementia.


Eligibility criteria:
inclusion criteria: * thirty patients with a diagnosis of probable ad according to the criteria of the national institute of neurological and communicative disorders association (nincds-adrda) (mckhann g et al.,1994) will be included in this study. exclusion criteria: * previous history of stroke * metabolic disturbances * other major medical illness or epilepsy * patients metallic objects in the body * patients subjected to a craniotomy in the past.

Keywords: alzheimer disease direct current stimulation cognitive function memory
clinical research of electro-acupuncture combined psychological intervention on internet addiction disorder

Conditions: Addiction

Summary: this research adopted multicentered, randomly and parallel control methods to observe the clinical effects of electro-acupuncture combined psychological intervention on internet addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.

this research was aimed to discuss the impact of acupuncture treatment on the impulsive behavior of internet addiction disorder (iad) sufferers, with the detection of magnetic resonance spectroscopy (mrs), the assessment of young's internet addiction test (iat), barratt impulsivity scale (bis-11) and go/no-go task, hopefully that this research could provide basis for the further study as well as the establishment of comprehensive assessment and treatment protocol of iad.

Eligibility criteria:
inclusion criteria: * subjects manifested three or more among the seven following conditions within one year could be defined as internet addiction: * (1) tolerance, complied with either one: ①satisfaction obtaining through markedly increasing time online ②spending same period of time online but with dramatic declining satisfaction. * (2) any following symptoms appeared after quitting internet surfing: ①obvious withdrawal syndrome: a-- quitted or decreased long time internet surfing. b--within one month after a, two or more following symptoms appeared: (a) depressed. (b) psychomotor fidgety. (c) compulsively thought things happened online. (d) hallucinated or dreamed about internet related stuff. (e) consciously or unconsciously carried out tapping the keyboard movement. c--the symptoms in b led to unexpected damage to one's social life, work and other important aspects of life, even depression. ②desperate to surf the internet or seek similar online service in a bid to relieve or avoid withdrawal syndrome. * (3) more frequent online behaviors or longer online time than planned. * (4) had been trying hard to reduce or control internet use but never succeeded. * (5) spent large amount of time on internet related things, such as purchasing online books, trying out new browsers, organizing downloaded files, etc. * (6) giving up or reducing important social, work or entertainment activities. * (7) despite unfavorable physical, mental, social or work consequences, continued to use internet. exclusion criteria: * other psychiatric disease history. * drug addiction history * severe cardiovascular disease, blood diseases, malignant tumors or any other contraindication of electro-acupuncture. * allergic to acupuncture treatment. * participants with intracranial diseases or abnormal scalp structure. * participants with metal implant. * color blindness, left handedness. * women in gestation or lactation period.
a community trial for visceral leishmaniasis (vl)

Conditions: Visceral Leishmaniasis

Summary: visceral leishmaniasis (vl) / kala-azar (ka) is a public health problem in the many countries in the world including bangladesh. where more than 90,000 vl cases have been reported since 1994. the disease is fatal if not treated. even with treatment the mortality rate is high (10%). vl is a vector-borne disease, caused by the parasite leishmania donovani (ld) and is transmitted by female sandfly sp. phlebotomus argentipes. not all people exposed to the ld parasite develop disease. according to our observation only about 30% of the infected with ld parasite develop disease within one year of diagnosis. malnutrition and intestinal helminth infection have been found to be associated with the risk of active vl. down regulation of th1 cellular immune response confers susceptibility to active vl. both malnutrition and intestinal helminth infection down regulate the th1 cellular immune response. till now there is no established prophylaxis against active vl among the people exposed to the ld infection. many studies including ours have been shown that periodic regular deworming reduced malnutrition significantly. micronutrient such as zinc and iron as well vitamin a supplementation also improve malnutrition and may enhance th1 cellular immune response. thus we hypothesize that periodic deworming and. micronutrient and vitamin a supplementation together may reduce the risk of active vl among the people exposed to the ld infection. the study will be carried out in the harirampur union, trishal, mymensingh. this area is highly endemic for vl. two hundred asymptomatic vl patients aged 2-60 will be enrolled to the study. children aged less than 2 years, pregnant women, active vl case, person with chronic disease, disable individuals and those who will refuse written consent will not be enrolled to the study. after enrollment subjects will be divided into two groups through randomization. one group will receive deworming and nutritional supplement (intervention group) and other group will receive placebo (placebo group). two groups will be followed for 12 months through active surveillance for developing of active vl. in addition morbidity data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline, before and after treatment of active vl will be carried out successful completion of the study and derived results from it will provide useful information that whether periodic deworming with micronutrient and vitamin a supplementation can reduce the risk of active vl among the people exposed to the ld infection.


Eligibility criteria:
inclusion criteria: * an individual with positive rk39 strip test, without past history of vl and/or symptom and sign of chronic illness. exclusion criteria: * children aged \< 2 years, * adults aged \> 60 years, * patients of active vl, * pregnant women, * people with chronic or debilitating conditions.

Keywords: visceral leishmaniasis kala-azar bangladesh malnutrition asymptomatic albendazole iron zinc vitamin a