Kornimate/medical-research-clean huggingface dataset:
efficacy of nefopam and morphine in balanced analgesia for acute ureteric colic

Conditions: Renal Colic

Summary: this study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.

the balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. we hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.

Eligibility criteria:
inclusion criteria: * acute flank with visual analog pain scale score equal or more than 5 * and most possible diagnosis after initial clinical exam is acute renal colic exclusion criteria: * pregnant or lactating women * patients whose use of any of the study drugs is contraindicated * patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses * recent episode of acute myocardial infarction or patients with significant heart failure * patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses * patients with bleeding tendency * patients who have history of any seizure * patients with documented organic brain injury * patients taking warfarin * patients whose primary diagnosis is not renal colic

Keywords: renal colic analgesia nefopam ketorolac
obesity, physical inactivity or dietary fat ?

Conditions: Obesity

Summary: obesity is the consequence of a chronic disequilibrium of fat balance. genetic factors determine predisposition to obesity, but the most often mentioned idea is that environmental factors, such as a high-fat diet and a sedentary lifestyle, join to favour weight gain and explain the increased prevalence of obesity in our westernized societies. since lipogenesis is negligible in humans, obesity represents the consequence of altered fat partitioning between oxidation and storage, likely due to a preferential directing of dietary fat towards adipose tissue and away from muscle. interventions that favour partitioning of dietary fat towards muscle for oxidation might thus protect against weight gain. exercise may be one kind of such intervention but the scant data on dietary fat metabolism does not allow clear conclusions, in particular in obese subjects. one question concerns the impact of the type of fat eaten: the effects of physical inactivity may vary according to the length and saturation degree of the fatty acids. we hypothesize that 1) physical activity of moderate intensity, independently of its effect on energy balance, will favor a preferential trafficking towards adipose tissue, will modify the expression of genes implicated in fat oxidation and storage and partly correct the abnormalities observed in obese subjects, 2) effects of physical activity vary according to the saturation degree of fat. twelve obese subjects, aged 18 to 55, will undergo tests before and after 2 months of training at current recommendations to ascertain dietary fat partitioning using stable isotopes and to determine changes in gene expression with muscle and adipose tissue microbiopsies.


Eligibility criteria:
inclusion criteria: * men between 18 and 55 * imc \>25 and \ 102 cm * familial antecedents of obesity * physical inactivity (pal\<1.5, according to mospa-questionnaire and accelerometry) * acceptation of physical training and body weight control during the study exclusion criteria: * any drug interfering with energetic or lipid metabolism * any contradiction to moderate physical training * diabetes or arterial hypertension treatment * any other pathology (cardiovascular, psychiatric, renal or hepatic disease, viral hepatitis or vih) * consumption of more than 40 g alcohol per day * recent voluntary or involuntary weight modification (3kg the next three months) * a recent trip outside france before and during stable isotope measures.

Keywords: obesity exercise fat oxidation overweigh (imc>25 and imc<30)
case series on the clinical performance of va clavicle and clavicle hook plate 2.7 systems

Conditions: Clavicle; Acromioclavicular Joint; Fracture

Summary: the purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the clavicle plate and clavicle hook plate system. a minimum of 76 patients with clavicle fractures or dislocations of the ac joint surgically treated with any plate from the dps va-lcp clavicle system will be enrolled in this observational post-market clinical investigation. outcomes will be collected until up to 2 years after surgery.

common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) \[1-3\]. the newly developed depuy synthes (dps) variable angle locking compression plate (va-lcp®) clavicle 2.7 system was designed to address these problems. the system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications. the objective is to describe the short and long-term clinical performance and safety of both systems, as well as the functional outcomes of this patient population. outcomes will be collected at baseline, 2 weeks, 6 weeks, 3 months, 6 months 1, and 2 years after surgery. in addition, the surgeons' experience and utility of the devices will be surveyed. for the short term evaluation, an interim analysis will be done as soon as 30 patients in each group have completed 6 months of follow-up (fu). the final evaluation of long-term outcomes will be done after 2 years of fu. all treatments and follow-up visits are according to standard of care.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * unilateral clavicel injury and primary surgical treatment within 21 days from injury with a dps va-lcp® clavicle plate according to manufacturer's instruction use: * va-lcp® clavicle plates 2.7: fixation of clavicle bone fragments * va-lcp® clavicle hook plates 2.7: fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint * va-lcp clavicle button hook plates 2.7: fixation of acromioclavicular joint dislocations * expected ability to attend postoperative fu visits * patient informed and consent obtained according to the irb/ec defined and approved procedures exclusion criteria: * stable clavicle fractures * systemic infection or infection localized to the site of the proposed implantation * concomitant nerve or vessel injury * polytrauma (injury severity score ≥ 16) * bmi ≥40 * uncontrolled severe systemic disease or terminal illness * intraoperative decision to use other implant
randomized trial to reduce environmental tobacco smoke in children with asthma

Conditions: Asthma; Lung Diseases

Summary: the purpose of this study is to test the effects of reducing indoor environmental tobacco smoke (ets) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.

background: asthma, a disease characterized by increased airway reactivity and inflammation in response to a variety of stimuli, is emerging as the most prevalent and serious environmental health problem among children in the united states. numerous studies, both prospective and cross-sectional, suggest that exposure to ets is one of the predominate risk factors for childhood asthma, but this has not been confirmed in a controlled trial. design narrative: the randomized, double-blind prospective trial involving 225 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on unscheduled asthma visits and asthma symptoms. the intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert to reduce exposure to ets in the experimental homes and inactive (placebo) units in the control group homes. the following hypotheses are tested. (1.0) children assigned to the ets reduction group will have a greater than 20 percent reduction in unscheduled asthma visits during one-year follow-up compared with those in the control group. (1.1) children assigned to the ets reduction group will have significant improvements in asthma symptoms compared with children in the control group. (1.2) children assigned to the ets reduction group will have greater than 10 percent reduction in ets exposure and exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group.

Eligibility criteria:
inclusion criteria: * age 6-12 years at enrollment * doctor diagnosed asthma by icd-9 billing codes (from billing records) * greater than 1 exacerbation(s) in the past year requiring an unscheduled asthma visit * exposed to the smoke of greater than or equal to 5 cigarettes in and around the house per day * lived within a 9-county area surrounding the city of cincinnati exclusion criteria: * already using a hepa air cleaner * lacked electricity * had a coexisting medical problem * family planned to move in the next year

Keywords: asthma hepa ets
examining the efficacy, safety and improved tolerability of travoprost bak free ophthalmic solution (travatan-z) compared to prior prostaglandin therapy

Conditions: Glaucoma

Summary: examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (bak) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.


Eligibility criteria:
inclusion criteria: * adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye) exclusion criteria: * age

Keywords: glaucoma
a tool to help patients with muscle symptoms after taking a statin medication.

Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Cardiovascular Diseases; Pharmacists; Placebo Effect

Summary: the goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. the main questions the trial aims to answer are: 1. compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (sams) more likely to retry statin therapy? 2. compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy? researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change. all participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. their clinician will then contact them for a follow-up visit as needed.


Eligibility criteria:
inclusion criteria: * kpco member * sold a statin from kpco pharmacy in the previous six months * have a gap of \>1.0x the days' supply in refilling their statin * patient who stopped therapy (or delayed filling prescription) due to some perceived side effect * has email address available in kp.org (and therefore has access to a computer with internet) exclusion criteria: * unable to verbalize comprehension of study or impaired decision-making * non-english speaking * limited life expectancy (e.g. hospice or palliative care) * pregnant or planning to become pregnant * patients on kaiser permanente's "do not call" list for research will also be excluded.
vac bioburden wound care assessment

Conditions: Upper Extremity Wound; Lower Extremity Wound; Soft Tissue Abscesses; Traumatic Wounds

Summary: the purpose of this study is to compare the microbiologic burden and need for further operative debridement of patients undergoing primary surgical debridement of infected tissue, soft tissue abscesses, or traumatic wounds of the upper and lower extremity.

bacterial bio-burden as measured by quantitative microbial pcr prior to debridement, immediately following initial debridement, after 2 days of vac veraflo (or conventional vac) therapy, and at the time of repeat operative debridements, if needed. we will use the microgen pcr platform (dba microgen diagnostics, llc, lubbock, tx.) to report on the bacterial burden (reported on a log scale of bacteria per gram) present at the time of debridement. our goal is to be able to assess the bioburden quantitatively at each time point to discern a change. exploratory outcomes to be measured: number of operative debridements required prior to reconstruction, number of days until final reconstruction, number of days until decision is made by surgeon that further debridements are no longer necessary, length of hospital stay, wound surface area will be monitored from enrollment through when the veraflo is removed. this is likely a 3-month interval.

Eligibility criteria:
inclusion criteria: * 18+yo with an injury or infection of the upper or lower extremity for which surgical debridement (in the operating room) followed by vac application is planned. exclusion criteria: - patient with wounds distal to the ankle.
exploring the interaction between metabolic disorders and nlpr3 inflammasome activation in dr inflammatory damage

Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Anti-vascular Endothelial Growth Factor

Summary: diabetic retinopathy (dr) is one of the most serious microvascular complications of diabetes. early diagnosis and treatment of diabetes is the key to prevent visual impairment in dr patients. this study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of dr patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with nlrp3 activation in dr inflammatory damage. dr patients with macular edema will receive anti-vascular endothelial growth factor (anti-vegf) treatment; these patients will be divided into two groups: responders group and non-responders group.


Eligibility criteria:
inclusion criteria: 1. patients \> 40 years old. 2. con (non diabetes control group)：patients undergoing phacoemulsification surgery. 3. ndr (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery. 4. npdr (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months. 5. pdr (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months. 6. patients voluntarily signed informed consent. exclusion criteria: 1. con (non diabetes control group)：patients with a history of other ophthalmic operations. 2. ndr (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history. 3. npdr (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography. 4. pdr (proliferative diabetes retinopathy):patients undergoing vitrectomy。 5. patients with active ocular inflammation, high myopia, pregnancy.

Keywords: diabetic retinopathy metabolomics nlpr3 diabetic macular edema anti-vascular endothelial growth factor
a study to assess the effect of a probiotic on upper respiratory tract infections in healthy children

Conditions: Upper Respiratory Tract Infections; Upper Resp Tract Infection

Summary: this study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.


Eligibility criteria:
inclusion criteria: 1. have a parent/guardian able to give written informed consent. 2. if ≥7 years, be able to give written informed assent. 3. healthy children aged 2 - 8 years old. 4. in general good health, as determined by the investigator. 5. attending a registered childcare provider or school. 6. willing to consume the study product daily for the duration of the study. exclusion criteria: 1. has urti symptoms at the time of randomisation. 2. are \<2 or ≥9 years old. 3. diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects. 4. has a family household member that smokes cigarettes in the home. 5. has taken antibiotics within the previous 2 weeks prior to randomisation. 6. has taken probiotic supplements within the previous 2 weeks prior to randomisation 7. daily intake of immune stimulating products, including but not limited to echinacea, vitamin c and zinc in the 2 weeks before randomisation (multivitamins allowed). 8. has any significant health conditions that would prevent them from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. 9. taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. 10. has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed). 11. has a gastrointestinal or chronic infective disease (i.e., coeliac disease, diarrhoea, crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, hiv, cancer, etc.), or with a history of such diseases. 12. planned extensive travel (for \>1 month) during the study duration. 13. parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. 14. participants may not be receiving treatment involving experimental drugs. if the participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study. 15. any participant who is the child of an employee of the study site or an atlantia clinical trials employee or their close family member or a member of their household.

Keywords: probiotic microbiome
comparison of intra-articular steroid injection and radiofrequency thermocoagulation in coxarthrosis patients

Conditions: Pain Hip Burning

Summary: the investigators aimed that the comparison of effectiveness of the intra-articular steroid injection and radiofrequency thermocoagulation of the sensory branches of the femoral and obdurator nerves in coxarthrosis patients

osteoarthirtis is a deficency of articular cartilge which is caused by genetic, metabolic and biochemical factors. this is a pathologic period with cartilage, bone and sinovium destruction. pharmacological treatments and/or phsiycal medicine may not be enough to reduce pain in patients with chronic pain of osteoarthiritis. intraarticular steroid injection is the most common used intervention method in analgesia of hip osteoarthirtis. thus; cartilage inflammation can be decelerated and osteophyte formation can be prevented. on the other hand; because of less vascularity of hip joint, frequent steroid injections may cause aseptic necrosis. in past decades, treatment to pain of hip joint pain caused by ostheoarthrits, radiofrequency ablation treatment is used to sensory nerves which cause pain. especially, it can be a solution in patients who do not want to undergo a surgery. patients diagnosed with coxarthrosis will be randomly divided into two groups. one group will receive intra-articular steroid injection and the other group will receive radiofrequency thermocoagulation to the hip sensory nerve branches (femoral and obdurator). it was planned to compare the vas scores of the patients before and 1-3 months after the procedure with their effectiveness.

Eligibility criteria:
inclusion criteria: * - older than 18-year-old * clincal, radiological (grade 3-4) and laboratory examinations ara related with diagnosis of hip joint osteoarthirtis * despite of previous medical and physical treatment, vas score \> 5 and above * norological examination without critical motor and sensory deficency * patients who sign informed consent. exclusion criteria: * coagulation disorders (bleeding diathesis) * usage of antitrombotic, anticoagulant medications * sepsis and local infection on intervention area * allergic to any of drugs which is used in intervention * without informed consent approval
evaluation of efficacy of lumbar plexus bloc after hip surgery

Conditions: Pain; Postoperative

Summary: compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. each group randomized, includes 30 patients. block performed preoperatively surgery under general anesthesia. postoperative evaluation of pain (vas) as first endpoint, and also morphine consumption via pca device. follow-up : 24h. expectation : sizeable reduction of pain with block, of duration.

compare lumbar plexus block (randomized) * ropivacaine 0.475%, 0.4 ml/kg * saline 0.4 ml/kg . each group includes 30 patients. block performed preoperatively. surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in o2. sufentanil added peroperatively as clinically needed. postoperative evaluation of pain (vas, by an independant blind observer) as first endpoint, and also morphine consumption via pca device. adverse effects (nausea, vomiting, etc) recorded follow-up : 24h. expectation : sizeable reduction of pain with block, of duration.

Eligibility criteria:
inclusion criteria: * adults * asa 1-3 exclusion criteria: * cognitive impairement * asa iv

Keywords: ropivacaine posterior lumbar plexus block hip arthroplasy analgesia postoperative