Kornimate/medical-research-clean huggingface dataset:
the role of ischaemia-reperfusion injury in the pathogenesis of muscle wasting after thoracic aortic surgery

Conditions: Muscular Diseases

Summary: single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery

some patients who are critically ill develop a syndrome of muscle weakness called intensive care unit acquired paresis. this syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the icu, reduced mobility and prolonged rehabilitation in survivors. it has also been shown to increase the risk of death on icu, due to an inability to wean patients from mechanical ventilation. most patients recover; however in some, the effects last for many years and patients may not recover fully. although there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. from the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to intensive care unit acquired paresis (e.g. infection, inflammation, oxidative stress, immobility). this research aims to investigate the role of these proteins in human tissue from patients who are at risk of intensive care unit acquired paresis. even patients who do not go on to develop the full syndrome, in the early stages of icu care, show some signs of muscle changes and loss of strength.

Eligibility criteria:
inclusion criteria: * all adult (\>18) patients undergoing major aortic or aortic valve surgery exclusion criteria: * pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)
cocktail approach for cytochrome p450 and p-glycoprotein activity assessment using dried blood spot

Conditions: Healthy Volunteers

Summary: phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. it consists of the administration of probe substances metabolised by a specific cytochrome or transported by p-glycoprotein (p-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. the administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and p-gp in a single test. the aim of this project is the validation of a phenotyping cocktail of low dose probe drugs for the assessment of cytochrome p450 and p-gp activities by simple capillary blood sampling and dried blood spot (dbs) analysis. the cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of cyp1a2, cyp2b6, cyp2c9, cap2c19, cyp2d6, cyp3a4 and p-gp, respectively. the modulation of the activity of cytochromes or p-gp will be evaluated by the administration of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic pathways or the p-gp mediated transport.


Eligibility criteria:
inclusion criteria: * healthy male volunteers aged from 18 to 60 years * bmi between 18 and 25 * understanding of french language and able to give a written inform consent. exclusion criteria: * smoker * taking drugs which alter cyps activity * renal or hepatic impairment * medical history of porphyria * medical history of chronic alcoholism or abuse of psychoactive drugs * liver transplantation * sensitivity to any of the drugs used * wearing contact lenses (risk of coloration with rifampicin) * ecg showing long qt interval (\>0.46sec) * alteration of hepatic tests * presenting genetic polymorphism of poor cyp 2b6, 2c9, 2c19, 2d6 metabolisers
oral versus intravenous acetaminophen for postoperative pain control

Conditions: Postoperative Pain; IVF

Summary: the investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen

oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. the perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. this medication is more commonly known as tylenol. intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. we are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. female, aged 18-45 4. ability to take oral medication and be willing to adhere to the study intervention regimen exclusion criteria: 1. known clinically significant liver disfunction 2. known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other 3. known current substance use disorder 4. chronic pain syndrome 5. weight less than 50 kg

Keywords: oocyte retrieval postoperative pain control in vitro fertilization tylenol
chronic posterior laryngitis with suspected laryngopharyngeal reflux

Conditions: Chronic Posterior Laryngitis (CPL)

Summary: this study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (cpl) in patients with documented pharyngeal acid reflux.


Eligibility criteria:
inclusion criteria: * one or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness. * patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria. * must have a total score of 5 or more on the chronic posterior laryngitis index (cpli) grading system. exclusion criteria: * a number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol. * if the patient is on certain medications this will also preclude them from taking part.

Keywords: chronic posterior laryngitis cpl pharyngeal acid reflux esomeprazole nexium
bronchial ultrasonography via a fibrescope: pilot study in tumoral disease

Conditions: Pulmonary Neoplasms

Summary: the exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. this allows targeted samples of the identified lesions. a new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

the main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology. the dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Eligibility criteria:
inclusion criteria: * assumed proximal neoplastic pulmonary pathology * planned bronchoscopy and biopsy exclusion criteria: * pregnancy * breastfeeding

Keywords: pulmonary neoplasms endobronchial ultrasonography primary
orientation of the lymphocyte response to the occurrence of atherosclerotic complications after kidney transplantation

Conditions: Disorder Related to Renal Transplantation

Summary: the incidence of atherosclerotic complications is increased after kidney transplantation. traditional risk factors do not fully explain this increased risk. atherosclerosis is an inflammatory disease in which all players in the immune response are involved. the impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation. the investigators therefore propose to study the impact of the expansion of regulatory t cells on the risk of atherosclerotic complications after transplantation. since november 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the grand east interregion. it was planned to include 500 patients and to date a little more than half have been included. after completion of the blood test, the tubes are routed over the biomonitoring platform (cic-bt 506 besançon) and the samples are stored in crb dijon. the atherosclerotic events are recorded prospectively. the investigators hope to implement as part of orly is, a second study to determine the impact of an expansion of regulatory t cells on the risk of atherosclerotic events. our hypothesis is that a cell rate regulatory t below the median results in an increase of 5% of atherosclerotic complications.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged over 18 years 2. patients receiving a renal transplant 3. patients able to understand the benefits and risks of testing 4. patients gave written informed consent. exclusion criteria: 1. inability to understand the advantages and disadvantages of the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study. 2. immunosuppressive therapy immediately prior to transplantation 3. cancer (except skin cancer) or malignant blood disease being treated; active infection; decompensated cirrhosis \[patients had cancer and considered as cured or in remission, patients with virus infection of hepatitis b or hepatitis c and having no cirrhosis may be included\]. this study is strictly non-interventional, participation in another study is not a cons-indication to the inclusion in this study and no exclusion period is required for inclusion in another study after inclusion in this study (art l. 1121-12 (loi n°2004-806 du 9 août 2004).

Keywords: transplantation immunology atherosclerosis
a study to test the interaction of two medications for treatment of overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together


Eligibility criteria:
inclusion criteria: * healthy adult males \& females ages 18-65; * body weight \>50kg; bmi between 19-32; * signed and dated informed consent; qtc interval \<450 msec; exclusion criteria: * resting blood pressure \>140/90 mmhg or hr \>100 at screening; * history of drug allergy or other allergy which, in the opinion of the pi, contraindicates their participation; * positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing; * positive hiv, hepatitis b, c at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study; * history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions; * history of chronic constipation and/or regular laxative use; donation of more than 500ml of blood within 56 days prior to dosing; * clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the investigators assessment

Keywords: solabegron, oxybutynin, healthy adults, drug interaction
alendronate compared to metformin in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: this is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

abstract background: since metformin (mf) induces osteoblast growth and differentiation while alendronate (aln) act as an antiosteolytic agent. the aim of the present study is to evaluate and compare the efficacy of 1% aln and 1% mf gel as a local drug delivery system in adjunct to scaling and root planing (srp) for the treatment of intrabony defects in patients with chronic periodontitis. methods: the study had 3 groups comprising of ninety subjects, divided into three groups 1% mf with srp, 1% aln with srp and placebo gel with srp. clinical parameters (plaque index (pi), modified sulcus bleeding index (msbi), probing pocket depth (ppd), and clinical attachment level (cal) were recorded at baseline, 3, 6 and 9 months. radiographic parameters intrabony defect depth (ibd) and defect depth reduction (ddr%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months

Eligibility criteria:
inclusion criteria: * all the subjects were systemically healthy * subjects with sites having cal ≥ 3 mm, ppd ≥ 5 mm, * vertical bone loss ≥ 3 mm on intraoral periapical radiographs (iopa) and * subjects with no history of periodontal intervention in the last 6 months. exclusion criteria: * patients with systemic diseases like cardiovascular disease * diabetes or hiv infection or on medications like corticosteroids which may impede the healing in periodontal tissues. * pregnant/lactating females * tobacco users * alcoholics * patients with unsatisfactory oral hygiene (plaque index greater than 1.5) * teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility * furthermore, patients allergic to metformin and alendronate or those taking metformin and alendronate systemically were excluded.

Keywords: alendronate, metformin
effects of long term macrolide antibiotic therapy in patients with copd

Conditions: COPD

Summary: the purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with chronic obstructive pulmonary disease (copd) by reducing the number of exacerbations and the degree of airway inflammation.

copd is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations. macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in copd. we hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with copd. if these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * clinically stable for 6 weeks * able to swallow tablets exclusion criteria: * clinically significant respiratory disease other than copd * women of child bearing age * patients receiving existing medication which may interact adversely with trial drug * history of clinically significant liver disease

Keywords: copd exacerbations airway inflammation
incentivized smoking cessation for diabetics

Conditions: Smoking Cessation; Diabetes Mellitus, Type 2

Summary: this pilot study aims to test the feasibility of providing incentives to patients with t2d contingent on remote biochemical verification using a smartphone carbon monoxide (co) monitor. the investigators will use an ecological momentary assessment (ema) smartphone application and co sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

individuals with type 2 diabetes (t2d) are at an increased risk of many cancers, though the causal link is not well understood. continuing to smoke after a t2d diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. smoking cessation is recommended as a standard treatment for diabetes. however, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting. contingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. this approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. this is a multicenter pilot randomized controlled trial that will recruit participants in oklahoma and in strathclyde, scotland. this pilot study aims to test the feasibility of providing incentives to patients with t2d contingent on remote biochemical verification using a smartphone carbon monoxide (co) monitor. the investigators will use an ecological momentary assessment (ema) smartphone application and co sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. two different contingency management structures will be explored to investigate the length of time incentives need to be offered. qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between uk and us health settings. the results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. the ultimate aim is to develop an effective intervention that could be scaled to the t2d population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.

Eligibility criteria:
inclusion criteria: * aged 18 to 75 * type 2 diabetes diagnosis greater than 1 year prior to enrollment * currently smoking at least 5 cigarettes per day * self-reported quit attempt in past 12 months exclusion criteria: * unwilling to make a quit attempt * unable to use smartphone ico monitor following training session
optimizing sedentary behavior interventions to affect acute physiological changes

Conditions: Sedentary Behavior

Summary: an emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including tv viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. we propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.

primary aim: to determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day. secondary aim: to assess whether existing and new measurement approaches can detect specific changes in sedentary behavior. exploratory aim: to establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).

Eligibility criteria:
inclusion criteria: 1. males or females 50 -70 years of age 2. able to attend 4 measurement visits with study staff in 3 consecutive weeks 3. spend at least 8 hours per day sitting 4. willing and able to wear study device for 21 days 5. able to read and write in english 6. able to provide written informed consent exclusion criteria: 1. do not sit for at least 8 hours per day 2. unable to attend 4 visits 3. diagnosis of serious chronic condition that would limit the ability to stand
impact of prophylactic octreotide to pancreatic exocrine secretion

Conditions: Periampullary Tumors

Summary: this study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. the patients were randomly assigned to intervention (use of octreotide) or placebo groups. octreotide was injected subcutaneously every 8 hours for 7 days. every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. the pancreatic juice is drained through the external stent by negative pressure and amounted. primary endpoint was the amount of pancreatic juice for each postoperative day. secondary endpoint was the rate of pancreatic fistula.

this study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. the patients were randomly assigned to intervention (use of octreotide) or placebo groups. octreotide of 100ug(1ml) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. the placebo group was managed with normal saline (1ml) for same period. every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. the pancreatic juice is drained through the external stent by negative pressure (barovac) and amounted. postoperative care of patients was same between groups such as pain control and supportive care. the amount of drained pancreatic juice via external stent was recorded everyday. primary endpoint was the amount of pancreatic juice for each postoperative day. secondary endpoint was the rate of pancreatic fistula.

Eligibility criteria:
inclusion criteria: * patients who will undergo pancreatoduodenectomy for periampullary tumors exclusion criteria: * patients with preoperative pancreatitis * patients who did not undergo pancreatoduodenectomy * patients who underwent bypass surgery or total pancreatectomy * patients who injection of octreotide less than 5 days