Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of torrent pharmaceutical ltd.'s olanzapine orally disintegrating 5mg tablets under fed condition

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's olanzapine orally disintegrating 5 mg tablets versus zyprexa® zydis® 5 mg tablets (reference formulation; eli lilly and company, usa). dosing periods were separated by a washout period during fed study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
valsartan efficacy on modest blood pressure reduction in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the manipulation of blood pressure in acute cerebral ischemia has been a matter of debate until now. the investigators are clearly in need of more detailed data on how antihypertensive treatment affects outcome in acute phase of stroke. this study will assess the effects of modest blood pressure (bp) lowering manipulation in acute period of ischemic stroke on death or dependency at 90-day.


Eligibility criteria:
inclusion criteria: * age over 18 years * patients admitted within 24 hours and can be enrolled within 48 hours after qualifying ischemic stroke onset * patients with systolic blood pressure above 150 mm hg and no more than 185 mm hg at least twice of 3 or more times at 5 minutes intervals after resting * baseline nihss score at least 2 points, not more than 21 points * full functional independence prior to the present stroke indicated by an estimated premorbid mrs score of 0 or 1 * informed consent from the patients or authorized representatives must be obtained in writing enrollment into the study exclusion criteria: * patients who received thrombolytic therapy (intravenous or intraarterial) * patients with acute intracerebral hemorrhage diagnosed by neuroimaging * patients with moderate or severe cardiac failure (new york heart association class iii and iv) * patients with medical condition which need urgent or special antihypertentive therapy, such as hypertensive encephalopathy, aortic dissection, acute renal failure, acute pulmonary edema, or acute myocardial infarction * comatose at screening * known or suspected cerebral aneurysm or arteriovenous malformation * any other clinical relevant serious disease, including uncontrolled diabetes, severe liver disease, or severe renal disease at the time of randomization * life expectancy of less than 3 months due to comorbid conditions, such as malignancy * participation in another drug trials or planned use of vascular interventions within the previous 30 days * women who are pregnant, breast feeding, or of child bearing potentials * contraindication to arbs, such as history of angioedema to arbs, renovascular hypertension

Keywords: acute ischemic stroke blood pressure valsartan death dependancy
bli based adenoma surveillance strategy

Conditions: Colorectal Polyp

Summary: bowel cancer is the third most common cancer in the uk. it develops through smaller growths in the bowel called polyps. early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. however, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. we therefore need to know which polyps to remove and which ones to leave. one way of doing this is to have a better look at these polyps. this can be done by new technologies. one of them is called blue light imaging (bli). this is a new light source at the end of the camera which is activated by the push of a button. it will help us in looking at these polyps more closely. this helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. it would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). by reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the trust, the study aims to see if using blue light during endoscopy helps us to identify and characterize small polyps better

advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. however, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. blue light imaging (bli) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. a specific bli classification was recently developed to enable better characterisation of colorectal polyps (bli adenoma serrated international classification - basic). the use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists. blast is a multicentre prospective observational study which will compare bli optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (\<10mm) identified at colonoscopy.

Eligibility criteria:
inclusion criteria: * \> 18 years of age able to provide informed consent exclusion criteria: * history of polyposis syndrome history of inflammatory bowel disease history of poor bowel prep
np2 enkephalin for treatment of intractable cancer pain

Conditions: Intractable Pain; Neoplasms

Summary: the purpose of this study is to examine the impact of intradermal delivery of np2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. a second purpose is to confirm safety and secondary efficacy measurements.

chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. existing treatments have limited efficacy and also suffer significant side effects. this is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of np2 in subjects who have intractable pain due to malignant disease. np2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. delivery of np2 directly to the site of pain caused by cancer is intended to provide increased enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Eligibility criteria:
main inclusion criteria: * histologically confirmed malignant disease. * intractable pain related to malignancy. * females must be postmenopausal or practicing birth control. * able to provide appropriate written consent. main exclusion criteria: * positive pregnancy test prior to receiving study treatment. * serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes). * evidence of active hepatitis b, hepatitis c, or hiv infection. * evidence of viral, bacterial, or fungal infection in the planned treatment area.

Keywords: pain cancer malignancy intractable gene therapy enkephalin opioid
effects of preoperative operating room environment presentation in hypertensive patients

Conditions: Hypertension; Anxiety; Blood Pressure

Summary: the aim of this study was to investigate the effects of preoperative operating room environment introduction on preoperative hypertension and blood pressure in hypertensive patients.

procedure to be applied: in order to eliminate the other factors that cause essential ht, the patients' blood pressure due to ht should be controlled, the surgery will be planned as the first case in the morning and the patients will need 8 hours fasting period. patients' gender, age, height, weight values, asa scores, body mass index (bmi) values will be recorded. hemodynamic parameters (blood pressure, heart rate and spo2 values) will be recorded in the services of the patients, in the preop unit and in the operation room. hypertension requiring intervention or additional medication will be excluded from the study. a randomized number of patients will be included in the study according to the results of power analysis. introduction of the operating room environment (iore): the procedure to be performed on the day of surgery will be simulated and accompanied by an anesthesiologist. the patient's hemodynamic data (blood pressure, pulse rate, respiratory rate, spo2) will be measured at the time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to the operating room with a service nurse. the hemodynamic data of the patient will be measured in the preop unit and the patient will be taken to the operating room with anesthesia doctor. here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale (st-stai) will be completed and the patient will be left in service again. the procedure will be similar to the process that the patient will experience on the operation day.

Eligibility criteria:
inclusion criteria: * elective surgery * informed consent, * essential hypertension was diagnosed, * between the ages of 40-80, * american society of anesthesiologists (asa) class ii-iii exclusion criteria: * drug allergy, * with a history of malignant hyperthermia, * uncontrolled hypertension, * cancer and psychological problems, * patients with cardiac and endocrine diseases * emergency surgery

Keywords: hypertensive patients introduction of operating room anxiety blood pressure
tas1r1, tas1r3, tlr2, tlr4, ca6 gene polymorphism on dental caries

Conditions: High Caries Risk; Low Caries Risk

Summary: the aim of this study is to examine the effects of tas1r1, tas1r3, tlr2, tlr4, ca6, gene polymorphism on caries risk in adults.

to date, genes can be grouped into categories based on the factor influencing dental caries. the major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits. ca6 exists in the human saliva and has a critical role of buffering, immune response and taste.toll-like receptors are expressed in the tongue gustatory papillae where they may initiate immune responses to pathogens.genetic variations in the tas1r1 and tas1r3 for umami cause perception of these tastes differently.

Eligibility criteria:
inclusion criteria: * adult be between 25 and 44 years old * subject has dmft (decayed, missing, filled, permanent tooth) ≥ 5, or, dmft ≥14 * same oral health, diet and socioeconomic status exclusion criteria: * systemic or genetic disorders * orthodontic appliances * pregnant women

Keywords: caries risk, gene polymorphisms
a prospective study of pharmacogenetic factors and gene expression profile

Conditions: Colon Cancer

Summary: this study is a parallel translational study of a randomized phase iii trial investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified folfox-6 regimen as adjuvant therapy for patients with stage ii/iii colon cancer (midas trial: protocol ncccts-467) . patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .


Eligibility criteria:
inclusion criteria: * curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection) * ajcc/uicc high-risk stage ii, stage iii colon cancer stage ii patient with high risk of relapse, if they fulfill one or more of the following criteria:(t4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion) * patients who are participating in the randomized phase ii trial of folfox 6 or 12 cycles * patients should sign a written informed consent for this translational study before or during participating in a randomized phase iii study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified folfox-6 regimen as adjuvant therapy for patients with stage ii/iii colon cancer exclusion criteria: * patients who do not agree with sampling of peripheral blood for genetic analysis * patients who are considered not to be suitable for this study at investigator's discretion
sustained-release morphine pharmacokinetics in roux-en-y gastric bypass subjects

Conditions: Bypass Complications

Summary: the purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (rygb) differ from subjects who did not. our hypothesis is that exposure is comparable. indeed, in the study obemo (determinants of oral morphine answer among obese patients before and after gastric bypass; nct00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

this is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and body mass index (bmi). in the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.

Eligibility criteria:
inclusion criteria: rygb group (n=12) : * subjects who undergone rygb for at least 24 months * stable weight since almost one year (or weight loss below 10kg over the last year) control group (n=12) : * volunteers subjects, matched for age, sex, and body mass index * no history of bariatric surgery same characteristics * subjects volunteers for the study * age 20-65 years * written consent exclusion criteria: * known allergy to morphine or naloxone * patients not affiliated to the french social security system * subjects yet recruited in a study with remuneration * abnormalities in liver function prothrombin ratio \ 5 times the usual values and/ or alanine aminotransferase \>5 times the usual values and/ or in renal function (creatinine clearance modification of diet in renal disease (mdrd) \< 60ml/ min * respiratory insufficiency defined by an oximetry below 90% * pregnancy and breastfeeding * use of drugs contra-indicated or not advised with morphine: * agonists-antagonists opioids ( buprenorphine, nalbuphine, pentazocine ), naltrexone * alcohol intake \> 30g by day * cough medicine morphine-like ( dextromethorphan, noscapine, pholcodine ) * codeine, ethylmorphine * other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol ) * barbiturates, benzodiazepines * rifampicin

Keywords: obesity roux-en-y-gastric bypass pharmacokinetics pain morphine
bms-354825 in patients with chronic accelerated, or blast phase chronic myelogenous leukemia or philadelphia positive acute lymphoblastic leukemia

Conditions: Leukemia, Myeloid, Chronic-phase; Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Summary: the purpose of this clinical research study is to understand the safety and efficacy of bms-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (cml) or philadelphia positive acute lymphoblastic leukemia (all) who are resistant to or intolerant of imatinib mesylate (gleevec).


Eligibility criteria:
inclusion criteria: * patients with philadelphia chromosome positive, chronic, accelerated or blast phase bml or all. * patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate. * men and women, 14 years of age or older. * adequate renal function. * adequate hepatic function. * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. exclusion criteria: * patients who are eligible and willing to undergo transplantation during the screening period. * women who are pregnant or breastfeeding. * a serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy. * uncontrolled or significant cardiovascular disease. * medications that increase bleeding risk. * medications that change heart rhythms. * dementia or altered mental status that would prohibit the understanding of rendering of informed consent. * history of significant bleeding disorder or unrelated to cml. * evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy. * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Keywords: chronic myelogenous leukemia (cml) chronic, accelerated, blast phase philadelphia chromosome positive acute (ph+all)
different modes of ventilation during cardiopulmonary bypass

Conditions: Postoperative Pulmonary Dysfunction

Summary: 66 patients divided into 3 groups with different modes of ventilation.

sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (p: pressure controlled ventilation, v: volume controlled ventilation, c: control) in accordance with the mode of ventilation. patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (pao2/fio2), alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.

Eligibility criteria:
inclusion criteria: * patients undergoingvalve surgeries * patients undergoing coronary artery bypass grafting surgeries exclusion criteria: * emergency cases. * off-pump surgeries. * patients with chronic lung diseases with forced expiratory volume in first second (fev1) or forced vital capacity (fvc) less than 40% of the predicted value. * massive blood transfusion during surgery. * complicated surgeries. * redo surgeries. * patients with decompensated heart failure prior to surgery. * patients refusal

Keywords: cardiopulmonary bypass pressure-controlled ventilation volume-controlled ventilation atelectasis pleural effusion lung compliance
fixation of displaced midshaft clavicular fractures in adults by intramedullary elastic rod

Conditions: Clavicular Fracture

Summary: clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. the rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. open reduction and plate-screw ﬁxation was considered as the gold standard with the advantages of ﬁrm ﬁxation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. intramedullary ﬁxation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate however, early intra-medullary implants, such as hagie pins and kirschner wires, have been gradually replaced due to insufficient stability. in addition, various nails such as elastic stable intramedullar

fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.

Eligibility criteria:
adults pt aged (16-55 ) how is active presented with mid shaft clavicular fracture, displacement with no comorbidity and excluding pt with polytrauma aged above 55y or below 16y ,pt with fracture lateral 3rd and pt with comorbidity

Keywords: fixation of midshaft clavicular fracture by intramedullary