Kornimate/medical-research-clean huggingface dataset:
laparoscopic versus open left colonic resection

Conditions: Colon Cancer; Benign Disease

Summary: the main goal of this study is to clarify if laparoscopy (lps) could become the standard approach in patients undergoing left colonic resection. 268 patient candidates to left colonic resection were randomly assigned to lps (n=134) or open (n=134) approach. postoperative care protocol was the same in both groups. trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. cost-benefit analysis was based on hospital costs. long-term morbidity, quality of life, and 5-year survival have also been evaluated.

the study design was explained to the potential participants who were asked to sign a written informed consent before randomization. eligible patients were randomly allocated to lps or open surgery. randomization list was computer generated. assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Eligibility criteria:
inclusion criteria: * age \> 18 years * suitability to elective surgery exclusion criteria: * cancer infiltrating adjacent organs assessed by computed tomography * cardiovascular dysfunction (new york heart association class \> 3) * respiratory dysfunction (arterial po2 \< 70 mmhg) * hepatic dysfunction (child-pugh class c) * ongoing infection * plasma neutrophil level \< 2.0x109/l

Keywords: left colon cancer
masked hypertension in patients with obstructive sleep apnoea

Conditions: Obstructive Sleep Apnea

Summary: assessment of the possible difference in masked hypertension prevalence when it is evaluated by automated office blood pressure measurement (aobpm) instead of office blood pressure measurement (obpm) in patients with obstructive sleep apnoea.

rationale: obstructive sleep apnoea is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50%+ blood oxygen desaturation \> 4%). it is considered to be an important risk factor for arterial hypertension. in these patients is highly prevalent nocturnal hypertension (nh) and also masked hypertension (mh). ambulatory blood pressure monitoring (abpm) is considered to be a gold standard for the diagnosis of nh and mh. results of abpm are compared with office blood pressure measurement which could be falsely elevated in some patients (white coat effect). for this reason, automatic office blood pressure measurement was developed. nowadays some devices like bptru were developed. this was validated on some patient groups but robust data for patients with obstructive sleep apnoea are missing. process: patient with ronchopathy and suspected obstructive sleep apnoea undergo automated office blood pressure monitoring followed by office blood pressure monitoring at the department of exercise medicine and cardiovascular rehabilitation. after education, ambulatory blood pressure monitor will be provided to patients for the following 24 hours. in the same night, respiratory polygraphy will be performed in the sleep laboratory, department of respiratory medicine, university hospital olomouc. all data will be statistically evaluated after completion of the target number of subjects. patients without obstructive sleep apnoea (apnoea-hypopnoea index \< 5) will not be included in statistical evaluations.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnoea syndrome exclusion criteria: * non- compliance of patients with blood pressure monitoring
pk of mmf in cadaveric vs living donor liver transplant recipients

Conditions: Transplantation, Liver

Summary: the purpose of this study is to measure the amount of mmf and tacrolimus concentration in the blood at a given time. currently mmf is ordered as a set dose and tacrolimus is given based on body weight. while the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). the way these different types of transplants break down drugs could be different. measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.

the purpose of this study is to measure the amount of mmf and tacrolimus concentration in the blood at a given time. currently mmf is ordered as a set dose and tacrolimus is given based on body weight. while the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). the way these different types of transplants break down drugs could be different. measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose. 12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study. each patient will have 12 (twelve) blood samples (half a teaspoon) drawn at 0,1, 2, 3, 4, 4½; 5, 6, 7, 8, 10 and 12 hours from an intravenous line placed during the operation. at the same time, 24-hour urine will be collected to measure your kidney function. after 4 to 6 days post transplant when the will be switched to oral mmf, again 10 (ten) blood samples a half teaspoon each will be drawn at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant. total blood drawn over 3 months will be about 7 tablespoons. a 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit (as a standard of care). the 24-hour urine will be collected at 1 and 3 months after transplant as well. if a woman, who could become pregnant, a pregnancy test will be done before your transplant. they would also have to use birth control during the study period and 6 months after the completion of study.

Eligibility criteria:
inclusion criteria: * adult * female patients * negative pregnancy test * willing for contraception during the study period and 6 weeks after study exclusion criteria: * serum creatinine \> 2.5 mg/dl * on dialysis * hiv +ve * re-transplantation * on ventilator * multi-organ transplant * platelets \< 50,000 * wbc \< 2,500

Keywords: mycophenolate mofetil hydrochloride pharmacokinetics tacrolimus
influence of mechanical ventilation mode on arterial pressure variations- a pilot study

Conditions: Blood Pressure; Critical Illness; Hypovolemia

Summary: mechanical ventilation has been known to produce changes in the flow of blood through the major blood vessels in the body. these changes may go undetected, but with continuous arterial blood pressure measurements, changes in the arterial waveform can be visualized. although we know that these arterial pressure variations occur during mechanical ventilation, little is known about the effects of various modes of mechanical ventilation on these changes. the most common modes of ventilation used in icu are volume control, pressure control and airway pressure release ventilation. objective we have designed a prospective randomized pilot study to determine the effects of the commonly used ventilator modes on the arterial pressure.


Eligibility criteria:
inclusion criteria: patients 18 yrs of age and older, patients on mechanical ventilation, patients deeply sedated in the icu with rass scores of atleast -3, patients having an a-line for blood pressure monitoring, patients with stable hemodynamics. exclusion criteria: patients with moderate-severe ards, patients requiring high inspiratory oxygen requirements, high peak inspiratory pressures requirement for ventilation, presence of arrhythmia, patients with spontaneous breathing activity, patients on weaning mode, patients having chf or cor pulmonale.
anti-vegf therapy versus dexamethasone implant for dme

Conditions: Clinically Significant Macular Edema Due to Diabetes Mellitus

Summary: we look at a randomized comparative study of 2 fda approved anti-vegf agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.

a randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 fda approved anti-vegf agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients. patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. primary inclusion criteria are : well controlled diabetes(hba1c\<7%) and co-morbidities. central subfield thickness of 300 microns or greater bcva \< or equal to 6/12. exclusion criteria: contraindications to the aforementioned drugs confounding ocular co-morbidities that can affect visual assessment(except cataract grade ii or less as per the locs iii classification) refusal for enrolment a comprehensive ocular and systemic examination will be performed along with fundus fluorescein angiography, optical coherence tomography and intraocular pressure measurements with the goldmann applanation tonometer. the bcva will be recorded using snellen's chart intravitreal injections will be administered using a standardized technique and under strict asepsis. no postoperative antibiotics will be given. patients will be followed on postoperative days 1, 7 and then monthly for 2 years. at each visit, the bcva, iop, ocular exam and oct scans will be performed at each visit. patients will be treated as per the guidelines laid out for the treat and extend study. for the dexamethasone implant, re-injections will be allowed first 3 months after the first injection. switch therapy is permissible for anti-vegf agents after 6 months; first to the other anti-vegf(for 6 more injections) and then to the dexamethasone implant. rescue laser therapy is as per physician's description. primary outcome measure: the bcva in each group from baseline to final follow-up at 2 years. secondary outcome measure: change in cst from baseline to years, the number of injections required per group and the complications, if any. statistical analysis will include demographic descriptions, the shapiro wilk test to look for normality of distribution, multiple measures anova test, fisher's exact test, chi-square test and paired and unpaired t-test wherever appropriate.

Eligibility criteria:
inclusion criteria: * well controlled diabetes(hba1c\<7%) and co-morbidities. central subfield thickness of 300 microns or greater bcva \< or equal to 6/12. exclusion criteria: * contraindications to the aforementioned drugs confounding ocular co-morbidities that can affect visual assessment(except cataract grade ii or less as per the locs iii classification) macular ischemia or proliferative disease refusal for enrolment
the role of periodic alveolar recruitment maneuvers in intraoperative protective ventilation

Conditions: Mechanical Power; Alveolar Recruitment Maneuvers; Protective Ventilation; Postoperative Pulmonary Complications

Summary: the goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. it aims to answer whether a periodic alveolar recruitment maneuvers (parm) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: parm alone (alveolar recruitment maneuvers \[arm\] repeated every 30 min), positive end-expiratory pressure (peep) alone (a peep of 6 to 8 cm h2o), or a combination of peep and parm (a peep of 6 to 8 cm h2o combined with arm repeated every 30 min). the primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (pao2) / inhaled oxygen concentration (fio2) ratio (p/f ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (pacu) and three postoperative days, the concentration of soluble advanced glycation end products receptor (srage) and clara cell protein 16 (cc16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.


Eligibility criteria:
inclusion criteria: 1. undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h. 2. had an intermediate risk of developing postoperative pulmonary complications. 3. pulse oxygen saturation in room air ≥ 94%. 4. aged 60 to 80 years. exclusion criteria: * 1. had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery. 2. had a history of pneumonia within 1 month prior to surgery. 3. had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. had a progressive neuromuscular illness. 5. with an american society of anesthesiologists (asa) physical status of iv or higher. 6. intracranial hypertension. 7. body mass index (bmi) ≥30 kg/m2. 8. were involved in other interventional studies.
estimation of osteoporosis' prevalence in france: pilot study in the department of the alpes-maritimes

Conditions: Osteoporosis

Summary: the purpose of this study is to estimate osteoporosis' prevalence in france and is a pilot study in the department of the alpes-maritimes.


Eligibility criteria:
inclusion criteria: * patient member of caisse primaire d'assurance maladie exclusion criteria: * patient incapable of understanding the questionary

Keywords: osteoporosis
ruling out coronary artery disease and myocardial injury by biomarkers

Conditions: Coronary Artery Disease

Summary: a considerable proportion of patients with clinically suspected coronary artery disease (cad) do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis. in patients with suspected cad, we will assess the ability of cardiovascular biomarkers to identify patients with (a) angiographically normal epicardial coronary vessels (b) absence of significant epicardial coronary stenosis, as assessed by coronary computed tomography angiography (ccta). patients will be stratified according to the presence or absence of dynamic changes of high sensitivity cardiac troponin t levels above the 99th percentile.

this is an observational study of patients with suspected coronary artery disease referred to coronary computed tomography angiography (ccta). the plan is to include 1000 patients prior to ccta at two centers. blood samples for biomarker measurement will be obtained prior to the procedures. the diagnostic results of the imaging tests will be compared to the levels of circulating troponins. patient will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization. symptoms of angina pectoris according to the canadian cardiovascular society grading of angina pectoris and symptoms of chronic heart failure according to the new york heart association classification of chronic heart failure will be recorded.

Eligibility criteria:
inclusion criteria: * consenting patient over the age of 18 referred to ccta for suspected coronary artery disease exclusion criteria: * inability to provide informed consent. * short life expectancy (\<12 months) due to non-cardiovascular disease
a study of bbt002 in healthy volunteers (hvs) and in adult patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is a randomized, blinded, placebo-controlled single (sad) and multiple ascending dose (mad) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of bbt002 in healthy volunteers (hvs) and in adult patients with chronic obstructive pulmonary disease (copd).

the study consists of three parts: * part a (single dose in hvs in sequential ascending dose cohorts, sad in hvs part) * part b (three repeated doses in hvs in sequential ascending dose cohorts, mad in hvs part) * part c (two repeated doses in patients with copd, mad in patients part)

Eligibility criteria:
key inclusion criteria (parts a, b, c) 1. age of 18-65 years (hvs), 35-75 years (patients) 2. body mass index between 18-32 kg/m², capped at 120 kg 3. negative pregnancy tests for women of childbearing potential 4. willingness to refrain from alcohol consumption for 24 hours prior to each study visit 5. non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers 6. adequate contraception use (for men and women of childbearing potential) 7. no clinically significant abnormalities or history of relevant diseases key inclusion criteria (part c only) 1. documented history of copd with a post-bronchodilator fev1/fvc \< 0.70 2. fev1 ≥ 30% and fev1\<80% predicted at screening. key exclusion criteria for (parts a, b, c) 1. positive viral serology for human immunodeficiency virus (hlv), hepatitis c virus (hcv), or hepatitis b (hbv) 2. immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections 3. history of major metabolic, dermatological, liver, kidney, hematological or other significant disorders 4. clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function 5. positive drug/alcohol tests or abnormal vital signs at screening or day -1 6. abnormal electrocardiogram(ecg) findings 7. history of drug/alcohol abuse in the past 2 years 8. history of severe allergic reactions or hypersensitivity key exclusion criteria for (part c only) 1. current diagnosis of other significant pulmonary disease 2. significant or unstable cardiovascular diseases 3. recent clinically significant infection 4. inability to perform spirometry
early phase 2 clinical study of ts-142 in patients with insomnia disorder

Conditions: Insomnia Disorder

Summary: multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.


Eligibility criteria:
inclusion criteria: * outpatients * patients diagnosed with insomnia disorder according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * patients who scored 15 or higher on the insomnia severity index (isi) at visit 1 * other protocol defined inclusion criteria could apply exclusion criteria: * patients with a history of any of the following diseases according to the dsm-5 criteria: 1. hypersomnolence disorder 2. narcolepsy 3. breathing-related sleep disorders 4. circadian rhythm sleep-wake disorder 5. parasomnias 6. restless legs syndrome 7. substance/medication-induced sleep disorder * patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy * patients with a history of poorly controlled diabetes mellitus (hba1c \>8%) * patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (\>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder * other protocol defined exclusion criteria could apply
fexofenadine in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of tnf-α signalling


Eligibility criteria:
inclusion criteria * moderate to severe ra (disease activity score-28 joints: das-28 \> 3.2) were recruited. * age between 18 - 60 years having active disease according to the diagnosis of an experienced rheumatologist, being under treatment with disease-modifying anti-rheumatic drugs (dmards), not receiving cytokine inhibitors * signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. exclusion criteria: * history of biological dmards. * history/presence of acute heart disease, liver and kidney diseases, copd * intolerance or allergy to fexofenadine or methotrexate * alcohol abuse * any changes in using medication (changing the dosage or type of medicines * receive hormone replacement therapy, warfarin, and other anticoagulants
embryo aneuploidies and ovarian stimulation

Conditions: Embryo Aneuploidies

Summary: there is a considerable concern about the effects of controlled ovarian hyperstimulation (coh) for in vitro fertilization- embryo transfer (ivf-et) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos. the main question remaining is if coh may increase the aneuploidies rate in young and healthy women. therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a coh cycle. to get rid of the male factor influence, donated sperm will be used.


Eligibility criteria:
donor inclusion criteria: * 18 to 35 years old. * bmi: 18-25kg/m2 * regular menstrual cycles * normal kariotype * no previous controlled ovarian hyperstimulation (coh) treatments. donor exclusion criteria: * endometriosis * policystic ovarian syndrome * recurrent miscarriages. recipient inclusion criteria * aged until 45 years old * no systemic diseases * following egg and sperm donation treatment. recipient exclusion criteria: * uterine disease (polyps, myomas, mullerian defects) * recurrent miscarriages.

Keywords: aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis