Kornimate/medical-research-clean huggingface dataset:
perioperative use of a selective cox2 inhibitor in patients undergoing elective colorectal surgery: the effect on post-operative bowel motility and post-operative pain

Conditions: Prevention of Post Operative Ileus

Summary: perioperative celecoxib to promote bowel movement and to reduce post-operative pain after elective colonic resection.

post-operative ileus is a common surgical complication occurring in with up to 20% of patients, with a significant clinical and economical effect. many preventative measures have been tested to promote gastrointestinal motility following intestinal surgery have been suggested. the medical intervention in the proposed study includes administration of a selective cox-2 inhibitor, specifically celecoxib, in the peri-operative period following an elective colon resection. celecoxib is a nonsteroidal anti-inflammatory drug (nsaid) with anti-inflammatory, analgesic, and antipyretic therapeutic effects. the drug is approved for use in by the ministry of health in israel and in the united states. the study aims to assess the use of this widely used medication for evaluation of the clinical effect on post-operative bowel transit, as well as the drugs' effect on post-operative pain.

Eligibility criteria:
inclusion criteria: * patients between the age of 18 and 80 * patients planned for elective colorectal surgery with primary anastomosis * asa score of 1-3 * patients that are able to sign an informed consent and comply with the protocol exclusion criteria: * patients with inflammatory bowel disease * patients that require emergency surgery * patients with renal failure, measured by creatinine level \> 1.5 mg/dl (\>106.1 micro mol/l) * patients with significant liver failure (known cirrhosis, bilirubin level\>2 mg/dl or 34.2 µmol/l) * patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group. * patients treated chronically with any type of cox inhibitor. * patients treated with nsaids including aspirin 7 days prior to the date of surgery. * patients with active peptic disease * patient expected to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics or neuroleptics in the postoperative period * patient with dysphagia or that have a difficulty swallowing capsules or tablets, or is unable to tolerate oral medication * pregnant / lactating women. * patients participating in any other interventional clinical trial
pagetex® photodynamic therapy device for the treatment of extra mammary paget's disease of the vulva (empv).

Conditions: Paget Disease of the Vulva; Paget Disease, Extramammary

Summary: vulvar paget's disease is a rare skin tumour which affect caucasian post-menopausal women. the disease is revealed by erythematous, eczematous, pruritus and vulvar burns. the diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. the reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases). photodynamic therapy (pdt) is already used in some dermatological pathologies and could therefore be an alternative treatment. the objective of this study is to assess the efficacy and evaluate the safety of the new pdt device "pagetex" for the treatment of vulvar paget's disease.


Eligibility criteria:
inclusion criteria: * non-invasive, primary or recurrent vulvar paget's disease after surgical resection * ability to give informed consent. * ability to adhere to the study protocol * patients must have biopsy (\< 1year) proven recurrent extra mammary paget's disease * effective contraception for women of childbearing potential exclusion criteria: * invasive vulvar paget's disease * underlying adenocarcinoma * subject to photosensitive disorders / reactions * treatment with imiquimod / aldara 5% cream in the last 3 months * photodynamic therapy used to treat mpv lesions in the last 3 months * use of photosensitive agents in the last 3 months * treatment with an experimental drug in the 30 days prior to the start of the study, * allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate) * allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in metvixia® * patient with porphyria * patient already treated with topical corticosteroids on the injured area in the last 3 months * patients with immunity disorders (hiv, transplantation) * clinical follow-up impossible for psychological, family, social or geographical reasons, * legal incapacity * pregnant or lactating woman * refuse to participate in or sign the consent of the study

Keywords: photodynamic therapy (pdt) medical device paget disease metvixia®
4k versus 3d total laparoscopic bilateral oophorectomy: tools in comparison

Conditions: Ovarian Diseases

Summary: evaluate whether the 4k laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3d laparoscopy

all patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic doppler ultrasound and/or magnetic resonance imaging and/or ct scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. the primary objective of the study is to compare surgical times between the 3d and 4k vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system

Eligibility criteria:
inclusion criteria: * patients with benign ovarian pathology requiring bilateral oophorectomy * asa score \<3 * patients who have signed the appropriate informed consent * patients who are not pregnant or diagnosed with pelvic inflammatory disease * no history of prior major abdominal surgery exclusion criteria: * suspected neoplastic pathology * patients not eligible for surgery

Keywords: benign ovarian disease laparoscopy annessiectomy ovariectomy resident tridimensional high definition surgery 3d 4k
mind-body exercise for copd: a pilot study

Conditions: COPD

Summary: this is a pilot randomized controlled trial of feasibility and preliminary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * physician diagnosis of copd * fev1\<65% of predicted and fev1/fvc\<0.70 * ≥45 years old exclusion criteria: * copd exacerbation requiring er visit or hospitalization within past month * planned major pulmonary intervention in coming 3 months * severe peripheral vascular disease/claudication or other physical condition precluding walk test * inability to perform bicycle ergometry * severe cognitive dysfunction (mmse ≤ 24) * inability to speak english * current participation in a pulmonary rehabilitation or regular practice of tai chi
notal-oct v.2.5 vs commercial oct in amd patients

Conditions: AMD - Age-Related Macular Degeneration; Diabetic Macular Edema

Summary: primary objective: to evaluate the level of agreement between the notal-oct v2.5 and a commercial oct in the presence of fluid as identified in the oct images, in the central 10 degrees of the macula in amd (age-related macular degeneration) patients. secondary objectives: 1. to evaluate the level of agreement between the notal-oct v2.5 and a commercial oct in the presence of fluid as identified in the oct images, in the central 10 degrees of the macula in dme (diabetic macular edema) patients. 2. to evaluate patient experience when self-operating the notal-oct v2.5.

to evaluate the sensitivity and specificity regarding the presence and absence of fluid on oct images of amd patients. oct images from the central 10 degrees of the macula in amd patients will be obtained using the notal oct v.2.5 and a commercial oct device (zeiss cirrus / heidlberg spectralis). these images will be evaluated for the presence/absence of fluid in the images by a human grader. the sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the notal oct v2.5 images with the presence/absence of fluid in the commercial oct images. to evaluate the sensitivity and specificity regarding the presence and absence of fluid on oct images of dme patients. oct images from the central 10 degrees of the macula in dme patients will be obtained using the notal oct v.2.5 and a commercial oct device (zeiss cirrus / heidlberg spectralis). these images will be evaluated for the presence/absence of fluid in the images by a human grader. the sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the notal oct v2.5 images with the presence/absence of fluid in the commercial oct images. patients will complete a questionnaire regarding the usability of the notal-oct v.2.5 device

Eligibility criteria:
inclusion criteria: * ability and willingness to give informed consent (ic) * 18 years of age or older * diagnosis of amd (age-related macular degeneration) and/or dme (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record * ability to undergo oct (optical coherence tomography) testing * visual acuity of 20/400 snellen (6/120) or better in the study eye exclusion criteria: - any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.
an observational study evaluating patients with chronic liver diseases associated with hepatic steatosis

Conditions: Chronic Liver Disease

Summary: hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. the condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. diagnosing chronic liver diseases can be challenging and treatment may be limited. in-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. we therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.


Eligibility criteria:
inclusion criteria: * adult patients/healthy control participants (age 18 or above) who can give their informed consent * suspected liver disease: * non-alcoholic steatohepatitis * alcoholic steatohepatitis * autoimmune hepatitis * primary biliary cholangitis * primary sclerosing cholangitis * inflammatory bowel disease * polycystic ovary syndrome * hereditary haemochromatosis * chronic pancreatitis * cystic fibrosis * alpha-1 antitrypsin deficiency exclusion criteria: patients with: * malignant diseases * viral hepatitis * human immunodeficiency virus * contraindications to liver biopsy

Keywords: non-alcoholic fatty liver disease non-alcoholic steatohepatitis steatosis autoimmune hepatitis primary biliary cholangitis primary sclerosing cholangitis haemochromatosis alfa-1-antitrypsin deficiency chronic pancreatitis chronic liver disease inflammatory bowel disease omics mass spectrometry
determining feasibility and acceptability of sharing video recordings with patients with als and caregivers

Conditions: Amyotrophic Lateral Sclerosis

Summary: our objective in the proposed project is to: (a) operationalize and determine the feasibility and acceptability of a trial where clinic multi-disciplinary clinic (mdc) visits are audio/video recorded and shared with patients with als and their caregivers; (b) gather preliminary data examining the impact of routinely adding audio/video recordings of clinic visits to uc on self-management ability and other behavioral, health and health services outcomes at baseline (t0) and other regular interviews from enrollment (t1= 1 week, t2= 3 months); and (c) identify factors pertinent to the acceptability of our study protocol and the audio/video recording of visits.

we will conduct a single-site, two-arm, parallel group, patient-randomized, controlled, pilot trial with 3-month follow up, to determine the feasibility, acceptability, and potential effectiveness of sharing audio/video recordings of multidisciplinary als clinics with patients and their caregivers. we will recruit 24 patients with als and their caregivers over a recruitment period of 1 year. we are primarily interested in determining the feasibility of the trial and acceptability of the audio/video intervention. we will also explore the impact on the patients' ability to self-manage their care as well as exploratory outcomes, at baseline (t0 = pre-visit), at t1 (1 week), and at t2 (3 months).

Eligibility criteria:
inclusion criteria: * diagnosed and primarily treated for amyotrophic lateral sclerosis (als) * aged 18 years or greater * can communicate in english (verbally, on a computer, or with assistance) * have email * have internet access * willing to have their multidisciplinary clinic visit audio/video recorded for a 3 month period exclusion criteria: * those without the capacity to provide consent, either themselves or via proxy

Keywords: neurology health communications
feeding tube practices and colonization of the preterm stomach in the first week of life

Conditions: Preterm Birth

Summary: project summary rationale many nicu's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. the researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. the researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization. objectives the investigators plan to conduct an intervention study in premature infants receiving probiotics (\< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. the main outcome will be bacterial concentration in the stomach after one week of life. methods the study is a prospective, randomized controlled trial in preterm infants. infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. the intervention will last one week. the infants will be followed until discharge. the investigators plan to include 11 infants in each group. primary outcome concentration of bacteria in gastric aspirates on day seven.


Eligibility criteria:
inclusion criteria: * under 32 weeks ga at birth * admission time considered to be more than seven days * signed informed consent within 48 hours after birth exclusion criteria: * transfer to another hospital within seven days * major gastrointestinal malformations * no tube feeding within first 48 h of birth
caffeine supplementation, resistance training and blood antioxidant status

Conditions: Caffeine

Summary: the purpose of this study is to verify the effect of acute caffeine intake on resistance training volume and blood antioxidant status, in a randomised, double-blind, placebo-controlled crossover trial.

caffeine is one of the most commonly consumed psychoactive substances in the world. several previous studies confirmed that caffeine improves several aspects of exercise performance, including resistance training outcomes. interestingly, caffeine and its catabolic products, theobromine and xanthine, exhibit antioxidant and prooxidant properties. additionally, resistance training promotes the generation of reactive oxygen species, which are important for the cellular adaptation process. hovewer, to the best of our knowledge, there is no information as to how caffeine combined with resistance training affects blood antioxidant status. therefore, the aim of this study was to examine acute effects of caffeine supplementation on resistance training volume and blood antioxidant status in resistance trained men.

Eligibility criteria:
inclusion criteria: * written consent to participate, * medical permission by physician * "resistance-trained," defined as having a minimum of two years of resistance training experience * minimum of 2 workout sessions per week in the last 6 months exclusion criteria: * neuromuscular or musculoskeletal disorders * current injury * using any medications, dietary supplements or ergogenic aids which could potentially affect the study outcomes * a positive smoking status * potential allergy to caffeine

Keywords: sports performance, resistance training, nutrition, athlete
real world glycemic effectiveness of linagliptin

Conditions: Diabetes Mellitus, Type 2

Summary: a non-interventional cohort study using existing data from patients in the optum clinical database which contains electronic health record (ehr) data from providers across the united states to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness


Eligibility criteria:
inclusion criteria: * ≥ 1 written prescription for linagliptin (tradjenta®, jentadueto®, or jentadueto xr®)in the ehr (electronic health record) data during the identification period * ≥ 40 years of age based on the year of the index date * first active date in the ehr is ≥ 180 days prior to the index date * ≥ 1 diagnosis code representing type 2 diabetes (t2dm) in the ehr data during the 180-day pre-index period or on the index date * ≥ 1 hba1c value during the 180-day pre-index period or on the index date * ≥ 1 hba1c value 60 to 180 days after the index date exclusion criteria: * ≥ 1 written prescription, medication administration or medication history record for linagliptin or other dipeptidyl peptidase (dpp-4) inhibitor in the ehr data during the 180-day pre-index period * ≥ 1 written prescription or medication administration for a new antihyperglycemic medication other than linagliptin on the index date new antihyperglycemic medication will be defined as a written prescription or medication administration for any antihyperglycemic medication that was not present in the patient's written prescription, medication administration, or medication history records during the 180-day pre-index period. individual antihyperglycemic medications will be distinguished by generic name using the column labelled "medication name" in tables 2 through 13. combination products containing two generic ingredients will be considered as two distinct antihyperglycemic medications note: this exclusion criterion is designed to exclude patients from the study sample if they start a new antihyperglycemic medication other than linagliptin on the index date. patients that start a new antihyperglycemic medication in the follow-up period will not be removed from the study sample to avoid creating a biased sample. addition of a new antihyperglycemic medication during follow-up will be evaluated through the sensitivity analysis described in section 9.7.4.4. while we will be capturing additions of new therapies, discontinuation of linagliptin is not able to be accurately measured in electronic record data. the electronic record data capture prescriptions written by a prescriber, but it is not possible to know if patients received and adhered to their medication and there are no structured data fields to identify if and when a medication was discontinued by the patient or the provider * ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ transplant, or bone marrow transplant in the ehr data during the 180-day pre-index period or on the index date * ≥ 1 diagnosis code representing malignancy in the ehr data during the 180-day preindex period or on the index date
impact of continuous regional analgesia in severe trauma patients

Conditions: Limb Fracture

Summary: regional analgesia, based on its physiological effects and efficacy, is used for optimal perioperative pain relief. however, for acute pain in multiple trauma patients in a critical condition, it has not been prospectively studied. the use of regional anaesthesia in this group of patients extend to the management of trauma patients and of other painful procedures performed at the patient's bed. the use of ra in such patients must be analyzed in the light of associated conditions that can increase the risk of systemic toxicity and complications: coagulopathies, infection, immunosuppressive states, sedation and problems associated with mechanical ventilation. the investigators aim to assess the role of continuous peripheral nerve blocks (cpnb) in multiple trauma patients, in order to show the benefits in terms of opiates consumption decrease, sedation limitation, improvement in ventilator free days and patients outcome

inclusion of multiple trauma patients with limb fractures and need for sedation and prolonged mechanical ventilation. patients should meet the following criterias: pressure of cerebral perfusion\>60mmhg, normothermia, paco2 35-40 mmhg, ph\> 7.20, normal coagulation parameters, hb\> 8g / dl (without head trauma) or hb\> 10g / dl (if associated head trauma). randomization in two patients groups: "ra group" versus "nora group methods: group without locoregional anesthesia: sedation using midazolam and sufentanil: multi-daily adjustment of doses every 4 hours using behavioral pain scale score \ 4. group with locoregional anesthesia: sedation using midazolam and sufentanil: multi-daily adjustment of doses every 4 hours using behavioral pain scale score \ 4 + peronerval block catheter from 0 to 24h after admission in intensive care unit using ropivacaine 0.2% with a continuous infusion at 1ml/10 kg /h follow-up up to 5 days for the 2 group. the main objective: sufentanil consumption (reported in µg / kg / d) for the same levels of behavioral pain scale and ramsay scales values.

Eligibility criteria:
inclusion criteria: * patient older than 18 years * multiple trauma patient ( with or without head trauma) * patient admitted to icu * patient with limb fracture (s) * patient requiring sedation and mechanical ventilation for more than 48h * patient affiliated to a social security system * patient whose informed consent was obtained from the family exclusion criteria: * patient currently enrolled in another trial * patient with coagulation disorders * patient whose access to the puncture sites is not feasible (underlying lesions) * patient with allergies to local anesthetics (la) * patient whose family did not give informed consent * patient younger than 15 years and 3 months * tetraplegic patient * dying patients * patients with more than 3 different fracture sites

Keywords: intensive care unit ; limb fracture ; regional analgesia