Kornimate/medical-research-clean huggingface dataset:
effect of vasopressin vs norepinephrine on pulmonary oxygenation and lung mechanics in patients with hypertension therapy during one-lung ventilation : preliminary study

Conditions: Hypertension

Summary: hypotension during anesthesia often occurs because reduced systemic vascular resistance and blocked sympathetic nervous system by anesthetic drugs. in patients who are taking hypertension medication, blood pressure drops are exaggerated by inadequate compensation mechanism due to decrease of blood vessel elasticity and desensitization of baroreceptors. in one-lung ventilation (olv) during thoracic surgery, persistent perfusion of non-ventilatory lungs can lead to increased intra-pulmonary shunt and hypoxemia. as a compensatory mechanism, the gravitational effect and hypoxic pulmonary vasoconstriction occur. among these, hypoxic pulmonary vasoconstriction is associated with pulmonary vascular resistance. norepinephrine and vasopressin, which are commonly used in patients with hypotension, affect systemic and pulmonary vascular resistance. however, no studies have been done on lung oxygenation and pulmonary mechanics of these vasoactive drugs in patients undergoing surgery on one lung. therefore, the purpose of this study is to investigate the effects of vasoactive drugs, norepinephrine and vasopressin, in patients with hypertension.


Eligibility criteria:
inclusion criteria: 1. adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy with unilateral lung ventilation during surgery. 2. patients taking hypertension drug ccb(calcium channel blocker), arb(angiotensin ii receptor blocker), acei(ace inhibitor, angiotensin converting enzyme inhibitor) at least 4 weeks. 3. american society of anesthesiologists (asa) classification 2\~3 exclusion criteria: 1. patients with heart failure (nyha class iii\~iv) 2. patients who are having moderate obstructive lung disease or restrictive lung disease 3. low dlco (\< 75%) 4. patients with pulmonary hypertension (mean pap\>25mmhg) 5. patients with liver disease (ast level ≥100 iu/ml or alt ≥ level 50 iu/l) or kidney disease (creatine level ≥ 1.5 mg/dl) 6. body mass index (bmi) \> 30 kg/m2 7. patients who cannot read explanation and consent form 8. patients who are pregnant

Keywords: lobectomy
mesalamine and reproductive health study

Conditions: Colitis Ulcerative; Crohn Disease

Summary: the purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate (dbp) from the use of asacol with clinical and intermediate markers of male fertility, including semen quality, sperm dna damage, transcript profiles of sperm mrna and sncrnas, and reproductive hormones. hypothesis 1: high exposure to dbp from the use of asacol is associated with decreased sperm concentration and motility, and increased sperm dna damage. hypothesis 2: high exposure to dbp from the use of asacol is associated with decreased serum testosterone, altered lh:testosterone ratio, and decreased inhibin-b. hypothesis 3: high exposure to dbp from the use of asacol is associated with altered transcript profiles of sperm mrnas and sncrnas.

there are 2 ways you can participate in the study. option 1 involves 6 one-hour visits to the massachusetts general hospital (mgh) andrology clinic over a 9 month period. at each visit you would be asked to fill out questionnaires and to provide a urine, semen, and blood sample. following visit 2, you are asked to switch your brand of mesalamine medication. after 4 months, you change back to your original brand of medication. the change in medication will be done in consultation with your primary gi doctor. if the cost of co-payment is greater for the new brand of medication, we will provide compensation to cover the difference. in the case you do not have prescription drug health insurance coverage, the study will reimburse up to $4000 to cover the cost for asacol, pentasa or lialda medication taken during your study participation. option 2 involves 4 one-hour visits to mgh andrology clinic. at each visit you complete questionnaires and provide a blood, urine and semen sample. you are eligible for option 2 if you are currently taking asacol or asacol hd and do not want to change your medication.

Eligibility criteria:
inclusion criteria: * must be taking mesalamine medication. willing to switch brand of medication for 4 months or currently taking asacol or asacol hd. * has not taken steroid medication within the previous 3 months. is able to come to mgh hospital for 6 visits. exclusion criteria: * is not taking mesalamine medication. unwilling to switch brand of medication for 4 months. * is or has taken steroid medication within the past 3 months. is unable to come to mgh hospital for 6 visits. * has had a vasectomy or has documented infertility.

Keywords: inflammatory bowel disease
perceptions on expected outcomes of immunotherapy in advanced cancer patients with poor performance status

Conditions: Non-small Cell Lung Cancer

Summary: to better understand your feelings and expectations about immunotherapy

primary objective: 1. to compare expectations of survival benefit from immunotherapy between advanced cancer patients with poor performance status (ps) and their oncologists. we hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of survival beyond 2 years. secondary objectives: 1. to compare expectations of therapeutic benefit of immunotherapy between advanced cancer patients with poor ps and their oncologists. we hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of cure, quality of life improvement, and lower likelihood of adverse events. 2. to qualitatively describe the priorities and preferences for information of advanced cancer patients with poor ps when considering immunotherapy treatment. 3. to evaluate the associations between discrepant expectations with patients' sociodemographic and clinical characteristics. 4. to compare patient and oncologist expectations with actual treatment outcomes and survival.

Eligibility criteria:
inclusion criteria: 1. patients being considered for or within 2 months of starting immunotherapy for advanced cancer 2. patient ≥18 years of age 3. ecog ≥2 4. cognitively able to understand consent and complete questionnaire as determined by the interviewer at the time of study enrollment 5. english speaking 6. willing to participate in the study and sign informed consent 7. the study will include medical oncologists that treat advanced cancers exclusion criteria: 1. treatment for curative intent 2. presence of delirium (as determined by score \>13 on mdas 46, appendix a)
evaluation of cats tonometer prism in lasik subjects

Conditions: Glaucoma; Ocular Hypertension; Normal Tension Glaucoma

Summary: the cats tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a lasik procedure when compared to a standard goldmann prism, validating the human lasik eye findings comparing cats tonometer and goldmann prisms to intracameral pressure in cadaver eyes.


Eligibility criteria:
inclusion criteria: subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial: * at least 22 years of age and undergone lasik treatment * subject has a clear understanding, english speakingand agrees to all the conditions of the informed consent form exclusion criteria: * subjects will be excluded from participation if they meet the following criteria: * subject has undergone ocular surgery within the last 3 months or lasik within 6 months * pregnant or nursing women * those who have had previous corneal surgery excluding lasik * keratoconus * corneal scarring * microphthalmos * buphthalmos * dry eyes with clinical epithelial breakdown upon exam * lid squeezers - blepharospasm * nystagmus * corneal or conjunctival infection.
clinical system accuracy evaluation with onetouch® verio flex blood glucose monitoring system (bgms)

Conditions: Diabetes Mellitus

Summary: the objective of this study is the evaluation of system accuracy based on en iso 15197:2015 (iso 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. iso 15197:20132 was harmonized with the regulations of the european union as en iso 15197:2015. this harmonization had no impact on the requirements and procedu¬res in iso 15197:2013; changes were made to the foreword and an informative annex. in this study, system accuracy evaluation will be performed for onetouch® verio flex (lifescan europe) on behalf of lifescan scotland limited (customer) with three different reagent system lots.


Eligibility criteria:
inclusion criteria: * male or female, with type 1 diabetes, type 2 diabetes (or subjects without diabetes) * signed informed consent form * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study. * if blood glucose values \ 300 mg/dl shall be measured after short term alteration in insulin therapy: * male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy. * signature of subjects to document consent with these procedures on informed consent form. exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with potential risk during the test procedures (at the study physician's discretion) * current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * being unable to give informed consent * \< 18 years * legally incompetent * being committed to an institution (e.g. psychiatric clinic) * language barriers potentially compromising an adequate compliance with study procedures * dependent on investigator or sponsor * if blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2), subjects with type 1 diabetes, suffering from: * coronary heart disease * condition after myocardial infarction * condition after cerebral events * peripheral arterial occlusive disease * hypoglycemia unawareness
comparison of the effects of tenoxicam and paracetamol on postoperative pain

Conditions: Postoperative Pain, Acute

Summary: postoperative pain is generally caused by inflammation and oedema related to tissue trauma. surgical tissue trauma is caused by many factors such as cotery-related burns, surgical incisions, dissections, and instrumental procedures like cutting, stretching, or compression. the pain stimulus is triggered by mediators released by the traumatic tissue and transmitted to the spinal cord and then to the upper centres of the brain. tenoxicam is an analgesic, anti-inflammatory, and antipyretic drug with a long duration of action, included in the oxicam subgroup of nsaids. tenoxicam has been studied and found effective for many rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout, extra-articular disorders, bursitis, tendonitis, and osteoarthritis. the primary aim of this study was to compare the effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination analgesic applications on the postoperative vas score of double-jaw surgery patients. the secondary aim was to investigate the effects of these interventions on the number of both opioid and rescue analgesic drug consumption postoperatively.


Eligibility criteria:
inclusion criteria: * patients between 18-50 aged of both genders who were scheduled for elective bimaxillary surgery * classified as american society of anesthesiologists (asa) risk class i or ii exclusion criteria: * having liver or renal dysfunction * coagulopathy disorder, * having psychiatric or medical conditions that might impair communication or compliance with the study procedures * having allergy or contra-indications to the study drugs .pregnancy. * patients who were planned to undergo additional simultaneous surgical procedures such as genioplasty were not included in the study. -

Keywords: maxillofacial orthognathic surgery; pain management; postoperative pain; tenoxicam
chemotherapy plus radiation therapy in treating patients with head and neck cancer

Conditions: Esophageal Cancer; Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.

objectives: * determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus. * measure the impact of concomitant hyper-fhx radiotherapy on organ preservation, organ function and quality of life parameters. * identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring. outline: patients receive concomitant chemoradiotherapy with curative intent. patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure. the first cycle of chemotherapy will begin with po doses of hydroxyurea every 12 hours on days 0-5. fluorouracil is given iv on days 0-4. radiation therapy bid is given on days 1-6. cycles repeat every 14 days for a total of 5 cycles. the disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly. projected accrual: approximately 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed diagnosis of carcinoma * stage ii-iii (t2, t3, n0 or t1-3, n1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus * no n2 or n3 * measurable disease is not required patient characteristics: age: * not specified performance status: * zubrod 0-3 life expectancy: * anticipated survival is 3-4 years (median) hematopoietic: * wbc count at least 3.5/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * not specified renal: * not specified cardiovascular: * not specified pulmonary: * not specified other: * no infection or severe medical illness * not pregnant prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy surgery: * no prior surgery

Keywords: stage ii esophageal cancer stage iii esophageal cancer stage ii nasopharyngeal cancer stage iii nasopharyngeal cancer stage ii lip and oral cavity cancer stage iii lip and oral cavity cancer stage ii hypopharyngeal cancer stage iii hypopharyngeal cancer stage ii laryngeal cancer stage iii laryngeal cancer stage ii paranasal sinus and nasal cavity cancer stage iii paranasal sinus and nasal cavity cancer stage ii oropharyngeal cancer stage iii oropharyngeal cancer
progestin treatment for endometrial stromal cells in adenomyosis

Conditions: Endometriosis

Summary: long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. as a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. in the treatment of adenomyosis, however, the beneficial effect of progestin was limited. it might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis. our previous study revealed that the expression of killer inhibitory receptors (kirs) on nk cells was decreased in eutopic endometrium in women with adenomyosis. it may be a compensatory effect in which the nk cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. it implies that the formation of adenomyosis might be due to "abnormal" endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. this finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women. in this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. the endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (mpa) or danazol. quantification of il-6 and il-8 mrna in endometrial cells, and the concentrations of il-6 and il-8 in cultured media will be done with real time rt-pcr and elisa respectively. the expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment.

eutopic endometrium was obtained and separated into single endometrial stromal cell (esc) in women with adenomyosis (study group) and without adenomyosis (control group). after becoming pre-confluent (covering 80% of the culture well), esc was cultured for 8 days solely or with the addition of medroxyprogesterone (mpa) or danazol. elisa was done to measure il-6, il-8, and tnf-alpha concentrations of the culture media. real-time quantitative rt-pcr was done to measure il-6, il-8, and tnf-alpha rna levels in esc.

Eligibility criteria:
inclusion criteria: * women with adenomyosis * at early- to mid-secretory phases exclusion criteria: * postmenopausal * malignancy
plasmaexchange in early septic shock

Conditions: Septic Shock

Summary: sepsis is defined by the occurrence of a systemic inflammatory response syndrome (sirs) in the context of infection. unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\> 60%). death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vwf cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (tpe) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. this therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. the investigators designed the exchange trial to analyze in a randomized fashion the benefit of tpe as an add-on treatment to state of the art standard sepsis care. only patients with early septic shock (\ 0.4 ug/kg bodyweight/min) will be included. those in the treatment group will receive 3 tpes within three consecutive days. the primary outcome is 28-day all cause mortality. to show an assumed reduction from 60% to 45% in the experimental group, a sample size of 173 patients per group has been calculated. the overall sample size is therefore n=346. the recruitment period is 3 years (+3 months observation) and will be performed in 11 national centers in germany. secondary endpoints (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on day 1, 2, 3 before and after tpe and on day 4, 5, 7 and 14. project management and data monitoring will be organized by the hanover clinical trial center and biostatistics including a web-based randomization will be performed by the institute of biometrics (prof. koch) at hannover medical school. the investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease.


Eligibility criteria:
inclusion criteria: * onset of septic shock within less than 12 hrs * noradrenaline dose of ≥ 0.4 ug/kg/min bodyweight (target mad ≥ 65 mmhg) ≥ 30 min exclusion criteria: * age\ 80 years * pregnancy * known history of transfusion reactions
comparing metabolic characteristics of persistent critically ill non-covid and covid-19 patients

Conditions: Persistent Critical Illness

Summary: the corona virus disease-19 (covid-19) pandemic has resulted in an overwhelming number of intensive care (icu) patient admissions, generally for acute respiratory distress, often resulting in persistent critical illness (pci). little is known about their metabolic and nutritional characteristics compared to other non-covid (non-co) categories of patients. the aim is to compare the metabolic characteristics and gastro-intestinal function of the previously admitted non-co and covid persistent critically ill patients, and the adherence to the icu nutrition protocol. prospective observation study including two consecutive cohorts of pci, defined by a prolonged mechanical ventilation requirement longer than 10days.

the metabolic and nutritional characteristics of the covid-19 patients requiring prolonged icu treatment compared to other non-covid (non-co) categories of patients remain poorly described. the aim was to compare the metabolic characteristics of the previously admitted non-co and covid pci patients. prospective observation study including two consecutive cohorts of pci, defined as requiring a mechanical ventilation for \>10 days. the comparative cohort is the first patient cohort previously registered as nct03938961. variables: demographic data, severity score (saps2, organ failure (sofa) scores), nutrition risk screening (nrs) score, c-reactive protein (crp), blood phosphate. nutritional variables: energy intake (detail of protein, lipids, glucose), fasting time, feeding route, prealbumin values, bowel activity, insulin requirements outcome: length of mechanical ventilation, icu and hospital stay and outcome. descriptive statistics

Eligibility criteria:
inclusion criteria: * adult patients requiring more than 10 days on mechanical ventilation exclusion criteria: * patients refusing use of their coded data * admission for brain injury or after cardiac arrest * admission for major burns \>20% body surface area (bsa)

Keywords: critical care metabolism nutrition propofol sedation hypophosphatemia refeeding syndrome insulin resistance malnutrition