Kornimate/medical-research-clean huggingface dataset:
electronic cigarette and surgery (ecigarsurg)

Conditions: Smoke Inhalation

Summary: since decades, literature has shown that smoking has negative effect on postoperative outcome. recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers. the use of electronic cigarette (e-cigarette) is spreading through the world. despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent. this prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. the main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

this study used a standardized questionnaire that was filled in preoperative period

Eligibility criteria:
inclusion criteria: * protocol approval * patients scheduled for elective surgery exclusion criteria: * \< 18 ans * refusal * not speaking * emergency surgery

Keywords: electronic surgery outcome anesthesia cigarette
a comparison of the safety and efficacy of cefdinir oral suspension versus amoxicillin/clavulanate in pediatric subjects with acute otitis media

Conditions: Acute Otitis Media

Summary: the primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with aom.


Eligibility criteria:
inclusion criteria: * clinical diagnosis, documented by medical history and physical examination, is acute otitis media \<=1 week * clinical signs and symptoms include \>=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane). * at least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane. * have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry. * generally in good health based on medical history, vital signs, physical exam, and historical laboratory results exclusion criteria: * previous enrollment in this study. * enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start. * hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens. * presence of tympanostomy tubes or otitis externa at evaluation 1. * systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) prior to evaluation 1 or during the study. * treatment with a long-acting injectable antimicrobial agent (e.g., penicillin g benzathine) within 4 weeks prior to study drug administration. * concomitant infection, that requires additional antimicrobial therapy. * evidence of chronic, suppurative otitis media. * evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media. * presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response. * known, severe renal impairment (i.e., creatinine clearance \< 30 mumid1.73 m2). * history of augmentin-associated cholestatic jaundicehepatic dysfunction.
lifestyle intervention with an interactive video game for type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. therefore, the investigators analyzed if regular use of the interactive videogame wii fit plus over 12 weeks is able to improve hba1c and weight in patients with type 2 diabetes.

patients with type 2 diabetes were recruited via treating physicians or articles in magazines and newspapers. participants were randomized in an intervention and a control group. the intervention group was sent the wii, the balance board and the interactive video game wii fit plus and were instructed to use these items 30 minutes each day during the next 12 weeks. the control group got the items 12 weeks later. at begin and after 12 weeks of intervention participants (and additionally for the control group: after 12 weeks of waiting phase) sent their health parameters, which had been measured in the context of the disease management program type 2 diabetes as well as questionnaires about physical activity and quality of life to the study center.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diabetes duration \< 5 years * age 50-75 years * body mass index \> or equal to 27 kg/m2 * participating in the disease management programme type 2 diabetes mellitus * physical and mental able for study participation exclusion criteria: * insulin or antidiabetic medication (exception: metformin and dpp-iv-inhibitors) * regular physical activity * depression * tumors * change of smoking status during the past 6 months or during the study * participation in other studies during the past 6 months

Keywords: type 2 diabetes mellitus physical activity lifestyle change motivation patient empowerment
effect of abrupt plavix® discontinuation on platelet function

Conditions: Coronary Artery Disease

Summary: the well established importance of regular administration of antiplatelet drugs stands on firm grounds, as large meta-analyses have shown these therapies to significantly reduce the risk of death. plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce the risk of periprocedural thrombotic complications, for up to one year. as the current recommendations suggest clopidogrel use for no longer than one year, the drug is normally discontinued within that period. in the limited state of knowledge on antiplatelet drug withdrawal, an early sound of alarm has risen from early thromboembolic complications reported after the interruption of antiplatelet treatment used in prevention of ischemic vascular disease. although little information is available, discontinuation of thienopyridines has been associated with increased thromboembolic complications, mainly acute stent thrombosis. these complications may signal a platelet sensitization effect to aggregating stimuli by antiplatelet drugs taken chronically. the current study aims to evaluate the impact of clopidogrel discontinuation on platelet function, in order to shed light on underlying mechanisms leading to increased risk of acute thrombo-occlusive events.


Eligibility criteria:
inclusion criteria: * group 1: patients suffering from stable cad scheduled to discontinue clopidogrel therapy at least one month after stent implantation * group 2: stable clopidogrel-naïve cad patients * patients willing to participate in the study and to sign the informed consent form exclusion criteria: * acute coronary syndrome or revascularization in the last 3 months prior to enrolment * concurrent ingestion of nonsteroidal anti-inflammatory drugs (nsaids, including cox-2 selective anti-inflammatory drugs), ticlopidine, dipyridamole, warfarin or acenocoumarol * major surgical procedure within 1 month before enrolment * platelet count outside the 100 000 to 450 000/μl range * hematocrit \< 25% or haemoglobin \< 100 g/l * patient undergoing dialysis for chronic renal failure

Keywords: clopidogrel discontinuation platelet aggregation
brief delay in cord clamping and neurobehaviour in preterms

Conditions: Preterm Birth

Summary: research hypothesis brief delay(\>30 sec to \<60 sec ) in cord clamping as compared to early cord clamping (\< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age

delayed cord clamping (dcc) : well described phenomenon in term infants . * the optimal timing of clamping of umbilical cord in preterm infants : a subject of debate. * even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹ * this low cost intervention can have significant public health importance in resource constrained settings. * the effect of this intervention on neurobehaviour of preterm neonates has not been assessed. * this aspect has been identified by who and cochrane as a potentially researchable area

Eligibility criteria:
inclusion criteria: * all preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan. * infants delivered vaginally or by caesarean section in cephalic presentation * singleton pregnancy * parental consent exclusion criteria: * fetus with gross congenital anomaly * fetus with hydrops * rh negative pregnancy

Keywords: preterm birth
microcurrent dressing to treat infections, before, during and after surgery

Conditions: Shoulder Arthropathy Associated With Other Conditions; Shoulder Arthritis; Shoulder Osteoarthritis; Shoulder Pain

Summary: deep periprosthetic infection following total joint arthroplasty is a major complication. although it only occurs in a small percentage of patients (\~1%), it results in substantial morbidity and a decline in functional outcome. a two stage revision and exchange is commonly required in order to clear the infection and provide the best opportunity for prosthetic replantation. following removal of the infected components, a minimum course of six weeks of parenteral antibiotics is given and resolution of the infection confirmed through the esr, crp, and repeated aspiration of the joint. in most instances a temporary spacer of antibiotic-loaded cement is inserted at the first stage and removed at the second operation. propionibacterium acnes is a gram-positive, non-spore-forming, anaerobic bacillus found in lipid-rich areas, including hair follicles, sebaceous glands, and moist areas of the shoulder and axilla. because of its low virulence, infections caused by p. acnes typically have a low-grade, indolent course, with shoulder pain often the only presenting symptoms after prosthetic replacement. p. acnes is particularly challenging to both diagnose and to eradicate, and is a substantial source of morbidity with shoulder arthroplasty. jumpstart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. these microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. jumpstart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours. the use of jumpstart as a prophylactic preoperative dressing to alter the skin flora and thereby decrease the risk of prosthetic infection has not been investigated to-date. given the morbidity of a prosthetic infection, this would be a remarkably valuable intervention for any joint replacement procedure.


Eligibility criteria:
inclusion criteria: * limited to total or reverse shoulder arthroplasty * all patients 18 years of age and older exclusion criteria: * under the age of 18 * revision shoulder arthroplasty patients * sensitivity or allergy to sliver or zinc or latex
autologous cellular therapy with prp-pc in chronic lung diseases: an observational study li-004

Conditions: COPD ILD

Summary: for this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. as circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. several growth factors are released by activated platelets becoming honing cells for healing within the tissue. the exact long-term mechanism of action of prp-pc in the lungs remains under investigation. safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both copd and ild.

study objective(s) primary * to determine if pulmonary function improves following ceullar therapy secondary * to determine if participants' perceived quality of life related to breathing improves following cellular therapy to evaluate the safety of autologous prp-pc administration for chronic lung disease

Eligibility criteria:
inclusion criteria: 1. subjects age 18 and older 2. diagnosis of copd or an interstitial lung disease exclusion criteria: pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-
association of conformational high-dose radiotherapy and of hyperselective transarterial chemoembolization in the treatment of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: indication : hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (tace).

: phase ii controlled randomized trial, multicenter, comparing the benefit of additive conformational radiotherapy after therapy with hyperselective chemoembolisation (tace) with treatment using three tace treatments (standard of care).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * ecog 0-1 * life expectancy ≥ 6 months * histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (easl-aasld) in cirrhotic patients * maximum lesion size ≤ 9 cm * non-eligible for surgery or percutaneous therapy * premature child-pugh a or b (7 points for the child-pugh score) * ast and alt \< 7 x unl * technical possibility of conformational external radiotherapy * technical possibility of tace * all the tumor mass must be able to be treated by tace * written consent signed by the patient * patients affiliated to a social security system exclusion criteria: * metastatic illness * minimal lesion size ≤ 5 mm * non controlled viral replication b * history of radiotherapy at abdominal level * subjects capable of procreating without efficient contraception * pregnancy or nursing female patient * contraindication of tace or external conformational radiotherapy * any other concomitant experimental treatment * contraindication of doxorubicin * patients who are unable to respect enslaving respiratory constraints if used by sites * patients who are unable to understand information and to follow protocol instructions
effects of home based stabilization and kegel exercises on postnatal females

Conditions: Low Back Pain

Summary: to compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females.


Eligibility criteria:
inclusion criteria: * cesarean delivery. * multi gravida females. * postpartum low back pain last for 1 year exclusion criteria: * low back pain before pregnancy. * urogenital infections. * history of pelvic floor or lumber surgery. * malignancy. * pelvic or lumber fractures

Keywords: disability low back pain females quality of life stabilization exercises
molecular effects of topical calcipotriene on morphea

Conditions: Morphea; Localized Scleroderma

Summary: this study will look into how topical treatment with synthetic vitamin d3, calcipotriene ointment, used as standard of care, works in patients with morphea. skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in rna and protein. a skin biopsy of unaffected skin will also be obtained and used for a control. this is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. this study will look at the differences between affected and unaffected skin. this study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.


Eligibility criteria:
inclusion criteria: * subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included. * subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline. * age ≥ 18 years. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded. * subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study. * subjects may not be receiving any investigational agents. * subjects must not be pregnant or nursing. * patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
electrical stimulation for the treatment of pain following total knee arthroplasty using the sprint beta system

Conditions: Total Knee Replacement; Total Knee Arthroplasty; Pain; Postoperative Pain; Orthopedic Disorder

Summary: the purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. this study involves a device called the sprint beta system. the sprint beta system delivers mild electrical stimulation to nerves in the leg that received the knee replacement. the sprint beta system includes a small wire (called a "lead") that is placed through the skin in the upper leg. it also includes a device worn on the body that delivers stimulation (called the sprint beta stimulator). about half the subjects in this study will receive the sprint beta system (treatment group) and half will not (control group). both groups will receive the standard of care.


Eligibility criteria:
key inclusion criteria: * scheduled to undergo a primary unilateral total knee replacement procedure key exclusion criteria: * body mass index \> 40 kg/m2 * conditions that place the subject at increased risk of infection * history of valvular heart disease * implanted electronic device * bleeding disorder * allergy to skin surface electrodes and/or medical-grade adhesive tapes * pregnant

Keywords: electrical stimulation neurostimulation tka pain pain following total knee replacement total knee arthroplasty
fiber mix and glycemic response

Conditions: Type2 Diabetes Mellitus

Summary: this study determines the acute effect of a dietary fiber mix on blood glucose levels. participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. all participants will consume white bread as the control food.

there is some evidence for increased dietary fiber intake to positively impact on metabolic outcomes in patients with type 2 diabetes, potentially via modulating gut microbial composition and functions. we have developed a dietary fiber mix that is consisted of fiber of various physicochemical properties to maximize the fermentability of the supplement and thus its effects on the gut microbiota. since the fiber mix also contains nutrients that will raise blood glucose levels, we need to characterize the glycemic response to the fiber mix itself, before we can use it in an upcoming trial to determine the effect of dietary fiber supplementation on the gut microbiota and glycemic control. enrolled participants will be assigned to a subject group based on their diagnosis of type 2 diabetes and fasting blood glucose concentrations. participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes will be assigned to the prediabetes/diabetes group. for the other participants, those with fasting blood glucose \ 100 mg/dl will be assigned to the prediabetes/diabetes group. participants will attend 8 food testing visits over 2 weeks. for each visit, participants will attend the research facility in the morning after an overnight fast. they will consume either white bread (with 50 g of available carbohydrates as a control food) or 60 g of the fiber mix (as a drink). postprandial glycemic response will be assessed by changes in blood glucose levels, to be monitored using a continuous glucose monitoring system (freestyle pro). a sensor will be placed on the participant's arm and will stay on until the end of the study. participants will provide photos of all the food and drink and a brief description of what they have consumed throughout the 2-week study.

Eligibility criteria:
inclusion criteria * aged between 18 and 65 years * understand and be able to follow written and oral instructions in english * provide written informed consent exclusion criteria * receiving insulin for diabetes treatment * receiving injectable prescription medicine * self-reported allergy or intolerance to any ingredients in the test food * any conditions deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research that may interfere with study outcomes, at the discretion of the investigators * any conditions deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators

Keywords: type 2 diabetes dietary fiber glycemic response
clinical trial to assess the efficacy and safety of combination therapy of motireb 5/100 mg in functional dyspepsia patients.

Conditions: Functional Dyspepsia

Summary: a phase ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of motireb 5/100 mg in functional dyspepsia patients.


Eligibility criteria:
inclusion criteria: 1. male and female aged 19 years or older 2. patient with functional dyspepsia met the rome iii criteria or symptom assessment form exclusion criteria: 1. patient with peptic ulcer or gastroesophageal reflux disease 2. patients with previous gastrointestinal surgery 3. patients with history of gastrointestinal bleeding, mechanical obstruction, perforation 4. patients with history of gastrointestinal cancer 5. patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis. 6. patients with zollinger-ellison syndrome 7. patients with irritable bowel syndrome 8. pregnant or lactating women 9. patients with hepatic abnormality 10. patients with renal dysfunction or chronic kidney disease 11. patients who are judged by the investigators to be unsuitable to participate in the clinical trial.