Kornimate/medical-research-clean huggingface dataset:
topical gentamicin cream versus alternating gentamicin and mupirocin cream in peritoneal dialysis

Conditions: Rate of Exit Site Infection; Rate of Atypical Mycobacterial Infection; Rate of Peritoneal Dialysis

Summary: catheter-related infection, namely exit site infection and peritonitis, is the commonest complication of peritoneal dialysis. this complication causes significant morbidity and mortality in patients requiring peritoneal dialysis. topical application of mupirocin 2% cream was first proven to be effective in reduction of staphylococcus-related catheter infection in 1990s. subsequent randomized trial published in 2005 showed that gentamicin cream was superior to mupirocin 2% cream in reducing both gram's positive and gram's negative related catheter infection. however, a retrospective report published in 2007 puts the use of prophylactic antibiotic cream into a question. it reported an emergency of non-tuberculous mycobacterial infection in a dialysis center in hong kong after practising prophylactic application of gentamicin cream at the catheter exit site. the following prospective, randomized and open-label study aims to find out an optimal regimen of topical antibiotic prophylaxis in patients requiring peritoneal dialysis.

topical antibiotics therapy is a well-recognized prophylactic therapy towards the catheter exit site infection in peritoneal dialysis patient. previous data has shown the superiority of gentamicin cream over the mupirocin cream in this aspect. however, the efficacy of the combination therapy using gentamicin cream alternating with mupirocin cream has not been tested. there is a potention benefit of reducing drug resistant strain in the combination group theoretically.

Eligibility criteria:
inclusion criteria: 1. patient aged 18 years old or above 2. patient has tenckhoff catheter inserted 3. patient is expected to continue his or her dialysis in our center in the subsequent 3 years exclusion criteria: 1. patient fails to sign the written consent 2. patient known to have allergy to either gentamicin or mupirocin 3. patient has suffered from peritonitis or exit site infection 30 days before the enrollment. 4. patient, suffering from terminal illness, has life-expectancy of less than one year 5. patient expected to undergo peritoneal dialysis for less than one year, such as patients planning for elective renal transplantation or suffering from acute renal failure necessitating dialysis while waiting for the kidney to recover. 6. pregnant patient 7. patient known to be non-compliant 8. patient bound by another clinical study
a test of nutritional interventions to enhance weight loss maintenance

Conditions: Overweight; Obesity; Weight Loss Maintenance

Summary: the purpose of this study is to compare standard behavior therapy (bt), bt plus meal replacements (mr) and a condition focusing on the nutritional changes to the home food environment (hfe) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. a second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. this study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of mrs or a program of comprehensive nutritional change.


Eligibility criteria:
inclusion criteria: * male and female participants between the ages of 18 and 65 * body mass index (bmi; kg/m2) between 27-45 * able to travel regularly to the study location * interested in participating in a weight loss program. exclusion criteria: * currently enrolled in another organized weight loss program * lactose intolerance * taking medications that affect appetite (unless dosage had been stable for at least the previous six months) * history of gastric bypass or other surgical weight loss procedures * medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss * pregnancy or planning to become pregnant during the next two years - * breastfeeding * consuming an amount of alcohol that could interfere with study completion

Keywords: nutritional intake psychosocial outcome
faecal microbiota transplantation for microscopic colitis

Conditions: Microscopic Colitis

Summary: a pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.


Eligibility criteria:
inclusion criteria: * diagnosis of microscopic colitis * date of diagnosis/histological confirmation \< 12 months * active disease according to hjortswang's criteria exclusion criteria: * diagnosed with ulcerative colitis or crohn's disease * diagnosed with celiac disease * active gastrointestinal infection * previous bowel resection of bowel (except appendectomy) * previous cholecystectomy * treatment with systemic steroid within 4 weeks, including budesonide * antibiotics 3 months prior * severe immunodeficiency, * pregnancy, planned pregnancy and breastfeeding * treatment with constipants such as psyllium, loperamide, bile binders, opium drops or codeine up to 2 weeks before inclusion and during participation
crochet octopus in the process of heel lance in neonates

Conditions: Procedural Pain

Summary: the main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates. the hypothesis of the study was "crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".

the study was conducted as randomized controlled. it included term neonates born between may 2020 and august 2020 at a training and research hospital. the study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. during the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. control group neonates experienced the process without any intervention. as for the data collection, "newborn identification form", "neonatal-infant pain scale (nips)" and "observation form" were utilized. the whole process was video-recorded.

Eligibility criteria:
inclusion criteria: * being a healthy term neonates, * being 5-15 days, * taking of blood sample for guthrie test routinely. exclusion criteria: * admitted to the neonatal intensive care units * his/her being taken any analgesics prior to the intervention, * having any congenital anomalies

Keywords: neonate pain heel lance developmental care
nurse-led smoking cessation program with follow-up in healthy life centres: a randomized clinical trial

Conditions: Smoking Cessation; Smoking Behaviors; Nurse's Role; Cardiovascular Diseases

Summary: a better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. in this is prospective, multi-center, randomized, open, blinded end-point (probe) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . the primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. we also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.


Eligibility criteria:
inclusion criteria: * age\> 18 years and smokes at least 1 cigarette daily * hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization) * established atheroscledrotic cardiovascular disease * sign informed consent and is expected to participate according to ich /gcp exclusion criteria: * does not usually live or work in the vestre viken catchment area * any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical * lack of norwegian and english knowledge * short life expectancy (\<12 months)
prognosis value of non-invasive methods for the diagnosis of chronic liver disease

Conditions: Chronic Liver Disease

Summary: the aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

all consecutive patients with chronic liver disease will be followed during 20 years.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * chronic hepatitis b * alcohol liver disease * non alcoholic liver disease exclusion criteria: * ascitis

Keywords: diagnosis survival non-invasive method cirrhosis fibroscan
behavioral economics of human drug self-administration

Conditions: Drug Dependence

Summary: the objective of this protocol is to examine the utility of behavioral economics for understanding reinforcer interactions as they pertain to drug self-administration. in a series of 6 experiments, the researchers will attempt to quantify the effects of qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their interactions. this work represents a continuation of research by this investigator in the area of addiction and pharmacology.


Eligibility criteria:
inclusion criteria: * use of 20 or more cigarettes per day * co levels \>15 ppm * more than 12 alcohol drinks per week and beer as preferred alcoholic beverage
effectiveness of quetiapine xr on the control of symptoms of manic phase of bipolar disorder.

Conditions: Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State

Summary: the primary purpose of the study is to assess the efficacy of quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to bipolar disorder. this trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.


Eligibility criteria:
inclusion criteria: * patients with type i bipolar disorder in manic phase according to standard scales and physician criteria. * patients of both genders, aged 18-65 years old being at the first episode * patients with chronic bipolar disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality exclusion criteria: * psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to quetiapine, clinically severe disease, unstable diabetes mellitus, neutropenia, other laboratory abnormalities

Keywords: bipolar disorder bipolar affective psychosis mania manic disorder manic state
primary antibiotic prophylaxis using co-trimoxazole to prevent spontaneous bacterial peritonitis in cirrhosis

Conditions: Spontaneous Bacterial Peritonitis

Summary: a multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival

see above

Eligibility criteria:
inclusion criteria: 1. patients with child-pugh class b or c cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment. 2. patient at least 18 years of age 3. documented informed consent to participate exclusion criteria: 1. patients with current or previous spontaneous bacterial peritonitis (defined as ascitic polymorphonuclear (pmn) cell count \>250/mm3 with either positive or negative ascitic fluid culture without evident intra-abdominal surgically treatable source of infection. a white cell count \>500 cell/mm2 or positive microbial culture may be considered as evidence of previous sbp if the site pi considers this was in the context of a likely clinical diagnosis of sbp). 2. patients receiving palliative care with an expected life expectancy of \<8 weeks 3. allergic to co-trimoxazole, trimethoprim or sulphonamides 4. pregnant or lactating mothers 5. patient enrolled in a clinical trial of investigational medicinal products (imps) that would impact on their participation in the study 6. patients with serum potassium (\>5.5 mmol/l) related to pre-existing kidney disease which cannot be reduced\* 7. patients receiving antibiotic prophylaxis (except for rifaximin)\* 8. patients with long-term ascites drains\* 9. women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment 10. patients with pathological blood count changes 1. patients with haemoglobin (hb) \<70g/l\* 2. granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter\* 3. severe thrombocytopenia with a platelet count \<30 x109 /l\* 11. patients with severe renal impairment, with egfr \<15 ml/min\* 12. patients with skin conditions: exudative erythema multiform, stevens-johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms 13. patients with congenital conditions: congenital glucose-6-phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as hb köln and hb zürich 14. patients with acute porphyria 15. any clinical condition which the investigator considers would make the patient unsuitable for the trial. * it is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. patients can be re-screened for eligibility if this occurs.
pharmacokinetics and safety profile of digoxin in infants with single ventricle congenital heart disease

Conditions: Congenital Heart Disease

Summary: this is a prospective, multi-center, open-label, pk and safety profile study of enteral digoxin in children \<6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.

the eunice kennedy shriver national institute of child health and human development (nichd) funded this protocol titled "pharmacokinetics and safety profile of digoxin in infants with single ventricle congenital heart disease", protocol number nichd-2018-dgx01. the investigational new drug (ind) sponsor and principal investigator for this protocol is christopher p. hornik, md, mph. the contracting officer's technical representative (cotr) to represent the government for this task order is perdita taylor-zapata. the duke irb number for this study is pro00102130. this study employs a central irb, the wirb-copernicus group (wcg). the c-irb (wcg) study number is 20190888 / nichd-2018-dgx01. this is a prospective, multicenter phase 1 study with a primary objective to characterize the pharmacokinetics of enteral digoxin in infants with single ventricle congenital heart disease. the secondary objective is to determine the safety profile of enteral digoxin in infants with single ventricle congenital heart disease. digoxin is used for the treatment of heart failure in pediatric patients and acts by controlling numerous functions of the cardiovascular system. digoxin use in single ventricle congenital heart disease may decrease interstage mortality. the study will be conducted in approximately 48 subjects at approximately 13 investigational centers. the proposed duration of the study is approximately 196 (±) days. please see the protocol and synopsis for more information.

Eligibility criteria:
inclusion criteria: * diagnosis of single ventricle congenital heart disease * status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation * age ≤ 30 days of life at time of stage 1 palliation * age \< 6 months at time of enrollment * require treatment with enteral digoxin per their treating medical provider if their planned maintenance treatment dosing regimen is within the labeled dose range of 7.5 - 20 mcg/kg/day divided in 2 or 3 equal doses * informed consent from parent(s) or legal guardian(s) exclusion criteria: * serum creatinine \> 2 mg/dl at enrollment * diagnosis of second degree or higher atrioventricular conduction block at enrollment * diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment * known hypersensitivity to digoxin or other forms of digitalis * extracorporeal life support (i.e., ecmo, dialysis, ventricular assist device) at enrollment * received digoxin prior to enrollment * received or anticipated to receive a loading dose of digoxin. * any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
treatment effects of herbst appliance in skeletal class ii cases during prepubertal and postpubertal periods

Conditions: Class II Malocclusion, Division 1

Summary: the study was directed to compare the treatment outcomes of subjects with class ii malocclusion who were treated with herbst appliance before and after puberty.

thirty-six class ii patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). all patients were treated with metallic splint supported herbst iv appliance. pretreatment and post-herbst iv treatment cone beam ct(cbct) scans were obtained for both groups. dentoskeletal and tmj measurements made on the cbct scans were analysed.

Eligibility criteria:
inclusion criteria: 1. skeletal class ii malocclusion with retrognathic mandible (anb \>5°, snb\<76°) 2. normal growth pattern (sn/mp angle was in 25°- 35° range) 3. unilateral or bilateral class ii molar relationship greater than or equal to one-half a cusp width. 4. minimal or no crowding in the mandibular arch (0-5mm). 5. average inclination or slight retroclination of the lower incisor. 6. an overjet greater than 5 mm. exclusion criteria: 1. skletal class i 2. craniofacial syndrome.

Keywords: class ii malocclusion. prepubertal patients. postpubertal patients. herbst appliance.
5-minute mindful pain management strategy

Conditions: Pain; Chronic Pain; Musculoskeletal Pain

Summary: this project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute mindful mapping intervention for adults with chronic musculoskeletal pain (n=60) relative to a time- and attention-matched control condition.

this was a two-arm (mindful mapping vs. serial sevens), remotely delivered, parallel-group, pilot rct. all procedures were approval by the local irb and preregistered (nct06394765). written informed consent was obtained from all participants prior to their inclusion in the study. participants were randomly assigned (1:1) to either the mindful mapping intervention (n=30) or a control condition, serial sevens (n=30). randomization was performed using a computer-generated sequence.

Eligibility criteria:
inclusion criteria: * having a chronic pain diagnosis * being able not to commit to another (new) treatment during the course of the study * understanding english instructions fluently * being 18 and above exclusion criteria: * having learned to practice mindfulness meditation any time in the past * being unable to perform most basic tasks due to pain or pain treatment
pediatric hiv disclosure benefits study (phd-bs) - sankofa 2

Conditions: HIV

Summary: the purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 hiv pediatric clinics in ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.

in this 5-year study, the investigators would like to build upon the successful sankofa trial by testing the intervention in a larger scale study delivered in "real-world" clinic conditions over time in ghana. the purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 hiv pediatric clinics in ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. the study will recruit dyads of 720 children (ages 7-18) and their caregivers from twelve (12) clinics, which will be randomly assigned to each of the four roll-out schedules ("wedge steps"), with three clinics per step. the two groups in the study are usual care and disclosure intervention. during the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. no formal pediatric disclosure guidelines or educational materials exist in ghana. during the intervention period, the manualized, with standard operation procedures, sankofa intervention will be delivered. the intervention is guided by the disclosure model and contains key elements to target well-documented, modifiable barriers to promote disclosure. the primary outcome is disclosure after one year (48 weeks) of the intervention. secondary outcomes are antiretroviral medication adherence, health (virologic, immunologic, psychosocial, behavioral), cost, and implementation. the trial will be conducted with a strong team of interdisciplinary investigators at two universities in ghana, yale and johns hopkins university in partnership with the ghana ministry of health (moh), ghana health service (ghs) and a community advisory board.

Eligibility criteria:
inclusion criteria: * hiv infected children * children between the ages of 7-18 who do not know their hiv diagnosis (based on caregiver account and medical records confirmation) and their caregivers will be eligible to participate in the study exclusion criteria: * hiv-infected children less than 7 years * hiv-infected children with congenital or developmental disorders * hiv-infected children with comorbidities such as sickle cell disease or diabetes that require frequent clinic visits or hospitalizations * children with aids-defining illness or end stage aids.

Keywords: resources limited settings hiv infected children