Kornimate/medical-research-clean huggingface dataset:
peri-operative management of patients undergoing laparoscopic colorectal surgery

Conditions: Neoplasm; Diverticular Disease; Analgesia

Summary: the aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (pca) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. the second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.

patients will be randomized into one of 3 groups - a, b or c. in order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. each group will then either have an epidural, spinal or a pca for post operative analgesia depending on the randomisation. all patients will follow a common postoperative care pathway to standardize the other factors. patients will be asked to report parameters including pain visual analogue score (vas) chart three times a day. recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded. in addition whilst the patients fluid status is optimized during surgery with the oesophageal doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.

Eligibility criteria:
inclusion criteria: * patients with colorectal disease that requires a bowel resection who agree to have laparoscopic surgery with placement of an oesophageal doppler and a central line and who agree to be randomised with regards to a post operative analgesic regime. exclusion criteria: * patients will be excluded from the post operative analgesia trial if they have abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column, or for a reason identified by the anaesthetist. * patients will also be excluded if there is a contra-indication to oesophageal doppler such as oesophageal disease, recent oesophageal or upper airway surgery, moderate to severe aortic valve disease and bleeding diathesis.

Keywords: laparoscopic colon analgesia fluid optimised
the effect of vitamin d supplementation on glucose metabolism in non-diabetic african american adults

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is more common among african americans than caucasians. african americans are also at a higher risk for lower levels of vitamin d compared to other ethnic groups. the investigators don't yet know if there is a connection between not having enough vitamin d and type 2 diabetes in african americans. researchers have found that the less vitamin d caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for african americans. the investigators want to better understand how vitamin d status and diabetes risk are linked in african americans. also, the investigators want to see if supplementation with vitamin d will improve your blood pressure, blood sugar, \& insulin. all of these are in some way related to diabetes. the investigators want to measure changes in blood sugar \& blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes. the investigators hypothesize that vitamin d status is related to diabetes risk measured by hemoglobin a1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic african american adults and that body weight status may affect vitamin d status in response to vitamin d supplements compared to placebo.

participants will be randomly assigned to receive either a 60,000 iu vitamin d3 supplement every four weeks or an inactive placebo. all investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.

Eligibility criteria:
inclusion criteria: * african american by self-report * in good health exclusion criteria: * diagnosis of diabetes * health problems/medication affecting calcium and/or vitamin d metabolism * current use of vitamin/mineral/herbal/nutritional supplements * inability to swallow pills * pregnancy

Keywords: vitamin d status 25-oh d ionized calcium fasting glucose hemoglobin a1c fasting insulin glucose metabolism homa index blood lipids type 2 diabetes pth adiposity body fat percentage dual energy x-ray absorptiometry pulse wave velocity arterial stiffness flow-mediated dilation african american inflammatory markers
low dose ketamine for management of acute severe pain in the emergency department

Conditions: Pain

Summary: this study aims to address both the management and evaluation of pain. the primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. another aim is to examine the safety of low dose ketamine compared to opioids alone. the investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

management and assessment of pain in the emergency department (ed) can be challenging. treatment of pain is most often accomplished by parenteral opioids analgesics. however, inadequate analgesia is often a problem when opioids alone are relied on for pain control. in the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. ketamine may play a role in maximizing analgesia in the ed.

Eligibility criteria:
inclusion criteria: * english speaking * adults age 18-65 * able to understand and give informed consent * comfortable with the experimental protocol as outlined to them by the research team * severe pain, pain score of at least 50/100 on visual analogue scale (vas) or 5/10 numerical ratings score * acute pain, pain duration \< 7days * deemed by treating ed attending physician to require iv opioid analgesia * asa (american society of anesthesiologists) class i or ii exclusion criteria: * previously enrolled in the study * neurologic, respiratory, or hemodynamic compromise * gcs (glasgow coma scale) \<15 * pox \ 22 * sbp \ 180, or dbp \>110 * discretion of treating physician * pregnancy or breastfeeding * known or suspected allergy to ketamine or morphine * ketamine within 24 hours of presentation (prescription or illicit drugs) * conscious sedation in ed (per treating physician), includes ketamine (for non-study purposes) * known renal (cr\>2.0) or liver failure * unstable psychiatric disease (as per treating physician) * history of stroke * history of cardiac disease * prior myocardial infarction; angina (stable or unstable) * cardiac stents or bypass surgery

Keywords: ketamine acute pain pain control pain
distal vs. forearm radial artery access

Conditions: Coronary Artery Disease; Angina, Unstable; Angina, Stable; Non STEMI; Non ST Segment Elevation Myocardial Infarction; Acute Coronary Syndrome; Atheroscleroses, Coronary; Atherosclerotic Heart Disease With Ischemic Chest Pain; Chest Pain; Myocardial Infarction; Myocardial Ischemia; ST-segment Elevation Myocardial Infarction (STEMI)

Summary: the distal radial access (dra) to the coronaries has emerged recently. it's done via the distal radial artery in the radial fossa, which is known as the snuff-box. the rationale of conducting this research is to assess this new access advantages and disadvantages, in comparison with the standard conventional forearm radial access and examine if it's worthy to be a future alternative method for coronary angiography. it aims to randomly compare between the new distal radial access via the snuffbox and the conventional forearm radial access for percutaneous coronary angiography and angioplasty procedures. the objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time, and convenience of the patients and operators. candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery in the forearm. procedural and post procedural outcomes and complications are being reported while patients are in hospital. all patients undergo doppler ultrasonography within 24 hours after the procedure.


Eligibility criteria:
inclusion criteria: * patients who agree to participate in the study and sign the consent form. * patients with an indication for coronary catheterization * clinically stable patients * patients with palpable pulses on both access sites of the radial artery. exclusion criteria: * patients with stemi * patients with radial av shunt for hemodialysis * patients with previous cabg using radial artery * patients with previous cabg using lima, rima or both. * patients with renaud phenomenon or lymphedema

Keywords: cardiac catheterization coronary angiography coronary angioplasty snuff-box snuffbox snuff box radial fossa distal radial artery radial artery safeguard distal radial access distal radial angiography radial access angiography distal radial radial coronary arteries randomized controlled trial left distal radial artery percutaneous coronary intervention radial artery occlusion forearm radial access forearm radial artery coronary catheterization catheterization left distal radial angioplasty coronary artery disease radial vs distal
four interventions in the management of psychomotor agitation, safety and efficacy evaluation

Conditions: Psychomotor Agitation

Summary: this study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. all of the treatment options are already approved and currently used for this purpose. the options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. the investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.


Eligibility criteria:
inclusion criteria: * patients featuring psychomotor agitation, with clinical need for intramuscular injection exclusion criteria: * delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options

Keywords: violence aggression psychiatric emergencies psychomotor agitation violent patient
trial of s-1 plus cisplatin in gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-fu plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.

this is a randomized, controlled, open-label,multicenter study. patients are randomized to one of two treatment arms : s-1 plus cisplatin and 5-fu plus cisplatin.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * male or female. * age 18 -75. * previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study). * measurable disease, according to the response evaluation criteria in solid tumours(recist) * ecog performance status 0, 1 or 2 * haematological, biochemical and organ function: neutrophil count \>2.0 × 10 9/l, platelet count \> 100 ×10 9/l. serum bilirubin\ 5 × uln in patients with liver metastases,creatinine clearance \> 60 ml/min. * signed informed consent. exclusion criteria: * prior adjuvant/neoadjuvant therapy more than two regiments. * received any investigational drug treatment within 30 days of start of study treatment. * patients with active gastrointestinal bleeding. * neurological toxicity ≥ grade 2 nci-ctcae. * other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * history or clinical evidence of brain metastases. * serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * pregnancy women. * subjects with reproductive potential not willing to use an effective method of contraception. * patients with known active infection with hiv. * known hypersensitivity to any of the study drugs.

Keywords: gastric cancer
role of esophageal mast cell activation in noncardiac chest pain (nccp)

Conditions: Noncardiac Chest Pain (NCCP)

Summary: chest pain is a common clinical complaint. about 30% patients with chest pain will have a normal coronary angiogram and are described as having noncardiac chest pain (nccp). it is estimated that 25% of the population complain of chest pain at some time in their lifetime. the pathogenesis of nccp is unknown. esophageal hypersensitivity as a result of inflammation is considered to be an important mechanism in the development of this pain sensation. little is currently known about the interaction between inflammatory mediators and peripheral afferent nerve terminals in the esophagus. the mast cell is one of the most enriched pro-inflammatory cells in the gastrointestinal tract. activation of the mucosal mast cell releases a variety of mediators into adjacent tissues. we hypothesize that mediators released by mast cells sensitize esophageal nociceptors and induce pain sensation.

1. key objectives: to determine the density and activation of esophageal mast cells in non-cardiac chest pain patients. we expect to find mast cell activation, as measured by mast cell count or degranluation, tryptase staining, and histamine release, will be greater in nccp patients compared to controls, and the increased mast cell activation will correlate with the severity of nccp. these results will expand our understanding of the pathogenesis of esophageal originated nccp, and allow the development of new diagnostic and treatment options. 2. study population: (i) nccp (ii) reflux esophagitis (iii) control subjects. 3. summary of procedures: (i) symptom assessment by chest pain questionnaire; (ii) esophageal reflux evaluation by review of records of 24-hour ph monitoring; (iii) evidence of esophagitis by endoscopy; (iv) esophageal biopsy by endoscopy; (v) mast cell activation study in biopsy specimen by mast cell count, tryptase and transient receptor potential vanniloid-1 (trpv1) staining, and histamine release assay. 4. major risks \& discomforts: there are no major risks \& discomforts other than involved in standard upper gi endoscopy.

Eligibility criteria:
inclusion criteria: * nccp - presence of a history of chest pain with a negative cardiac evaluation, no evidence of gross esophagitis on endoscopy, and lack of any exclusion criteria; reflux esophagitis - presence of chest pain or heartburn, negative cardiac evaluation, lack of exclusion criteria and presence of esophagitis on endoscopy; * controls - lack of history of chest pain, lack of exclusion criteria and lack of esophagitis on endoscopy. it is anticipated that patients being evaluated for heme positive stool or gi bleeding would be included as controls. exclusion criteria: - history of ischemic heart disease, history of asthma, significant food allergies, celiac disease, chronic inflammatory conditions (sle, rheumatoid arthritis), atopic skin disease, varices, coagulopathy, recent drug treatment with steroids.

Keywords: nccp, mast cell, esophagus
verification of risk factors of thrombohemorrhagic complications in recipients after related liver transplantation

Conditions: Liver Cirrhosis; Liver Transplant; Complications

Summary: the aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.


Eligibility criteria:
inclusion criteria: * age over 18 years and up to 70 years; * signed informed consent for inclusion to the study; * end stage liver cirrhosis. exclusion criteria: * pregnancy; * extrahepatic factors influencing systemic hemostasis; * concomitant hematological diseases affecting the hemostatic system; * severe concomitant disorders.
home improvement initiative of the traitement optimisé medicamenteux after hospitalization

Conditions: Older Adult; Chronic Disease; Clinical Pharmacy; Surgery; Ambulatory Care

Summary: the hypothesis is that the intervention of an operational clinical pharmacy team (eopc), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization. the main objective of the study is to demonstrate that the intervention of an eopc in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay. the secondary objectives are to measure the impacts of eopc's intervention on: * unexpected readmissions, emergency use, medical complications and adverse drug reactions; * patient and health professional satisfactions (community pharmacists and physicians); * the costs of drug treatments in ambulatory care.


Eligibility criteria:
inclusion criteria: * patient (man or woman) * age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery; * affiliated to a social health insurance scheme; * for whom a return home is possible; * able to understand the objectives of the research and give informed, dated and signed consent. exclusion criteria: * patient (man or woman) * with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (smti); * with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team); * under the safeguard of justice; * under tutorship or curatorship.

Keywords: multicenter study before-and-after type study minimal risks and constraints
serranator® alto post market clinical follow up (pmcf) study

Conditions: Peripheral Arterial Disease; Arterio-venous Fistula; Arteriovenous Graft

Summary: the objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the serranator® alto in treatment of peripheral artery disease (pad), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

single arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (pad) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. the study will capture acute angiographic data.

Eligibility criteria:
* subject requires angioplasty * subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use
phototherapeutic keratectomy (ptk) on recurrent corneal erosions

Conditions: Recurrent Corneal Erosions

Summary: to determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (ptk) for recurrent corneal erosions.

a retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by ptk from 1996 to 2000 was performed. all eyes had failed to respond to conventional therapy. data regarding the preoperative and postoperative best-corrected visual acuity (bcva), spherical equivalent (se), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. the mean duration of symptoms prior to ptk was 18 months (range, 8 to 36 months). the corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the technolas 217c plano scan excimer laser. mean postoperative follow-up was 12 years (range, 10 to 14 years).

Eligibility criteria:
inclusion criteria: recurrent corneal erosions patients 21 to 50 years old conventional treatments have failed exclusion criteria: * diabetes * autoimmune diseases

Keywords: corneal erosions ptk
diabetes in neuropsychiatric disorders

Conditions: Schizophrenia

Summary: the purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis. we hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

antipsychotic medications are associated with an increased risk of diabetes. we focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Eligibility criteria:
* age 18-64 * maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study * no history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, cushing disease), * not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics) * no history of cocaine use in the previous 30 days, and * no laboratory evidence of diabetes at baseline (fasting glucose \<126 mg/dl or 2-hour glucose \<200 mg/dl on a glucose tolerance test)

Keywords: schizophrenia schizoaffective psychosis olanzapine