Kornimate/medical-research-clean huggingface dataset:
evaluation of miebo (perfluorohexyloctane) eyedrops in habitual contact lens wearers

Conditions: Dry Eye; Dry Eye, Evaporative; Dry Eye Disease; Evaporative Dry Eye; Evaporative Dry Eye Disease; Kerato Conjunctivitis Sicca

Summary: miebo (perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop. this drop was recently approved by the food and drug administration (fda) for the treatment of meibomian gland disease (mgd). all published data on miebo has been done in non-contact lens wearers. as contact lens dropout rates seem to be an ongoing problem for practitioners, we are performing this study utilizing this novel new drug with contact lens patients to determine if the drops assist comfort in typical soft contact lens wearing patients. if the study determines that miebo assists in the overall comfort of contact lens patients this could be a possible way to help keep patients in their contact lenses longer.

the study design is a single center, open label, double arm study with no control and no randomization. we will enroll 50 patients who are adjusted contact lens wearers who have corrected visual acuity of 20/25 or better at distance. 25 patients will be in daily disposable contact lens of varied manufacturers. the other 25 will be in monthly disposable contact lenses of varied manufacturers. subjects will insert the miebo eye drops four times a day, and with their contact lenses removed every day. subjects will be required to wait at least 30 minutes before inserting their lenses after drop use. subjects will be seen on day 0 for initial screening, on day 7 and finally on day 30. the window for visits on day 7 is +/-3 and for day 30 +/- 7 days. visits on day 7 and 30 will be conducted at least one hour post miebo insertion. overall vision and comfort will be assessed during the study. the primary endpoint is to show that miebo eye drops are safe to use in contact lens wearers. the secondary endpoint is to show changes in comfort in contact lens wearing individuals.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years of age * habitual contact lens wear for ≥ 60 days * willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol. exclusion criteria: * previous use or known allergy to miebo * subjects with corneal abnormality or eye pathology that would affect the outcome in the investigator's opinion. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.

Keywords: contact lens dry eye disease
the efficacy and safety of peg-rhg-csf in mobilizing autologous hematopoietic stem cells in lymphoma

Conditions: Lymphoma

Summary: a single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

the objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; kps score ≥70; ccr≥ 50 ml/min, tbil\< 25.65 umol/l, alt and ast \< 2 times the upper limit of normal value;

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old, regardless of gender; 2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; 3. kps score ≥70; 4. ccr≥ 50 ml/min, tbil\< 25.65 umol/l, alt and ast \< 2 times the upper limit of normal value; 5. anc ≥ 1.5×109/l，plt ≥ 80×109/l，hb ≥ 75g/l，wbc ≥ 3.0×109/l； 6. patients can tolerate chemotherapy； 7. no active infection before chemotherapy; 8. the retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form; 9. the researcher thinks that the subjects can benefit. exclusion criteria: 1. patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level); 2. those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before; 3. subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment; 4. severe mental or nervous system diseases; 5. those who are allergic to peg-rhg-csf, rhg-csf and any active ingredients or auxiliary materials of other preparations expressed by escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions; 6. pregnant or lactating female patients; women of childbearing age refuse to accept contraceptive measures; those who plan to become pregnant during the study period; 7. the researcher judges other subjects who are not suitable to participate.
prospective data collection of newly diagnosed hodgkin's disease and non-hodgkin's lymphoma cases

Conditions: Hodgkin Disease; Lymphoma, Non-Hodgkin

Summary: prospective data collection of newly diagnosed hodgkin's disease and non-hodgkin's lymphoma cases

prospective data collection of newly diagnosed hd and nhl.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed hodgkin's disease and non-hodgkin's lymphoma exclusion criteria: * patients with diagnosis other than hd and nhl.

Keywords: hd nhl
efficacy and safety of milnacipran in the treatment of fibromyalgia in an elderly population

Conditions: Fibromyalgia

Summary: participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (fms) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. the investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (fms), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.


Eligibility criteria:
inclusion criteria: * male or female patients. * age 65 years or older. * fibromyalgia diagnosed according to acr 1990 criteria. * pain score ≥ 10 on gracely scale at screening and baseline assessments. * discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation. exclusion criteria: * uncontrolled hypertension (bp ≥ 140/90) at screening or baseline evaluations. * baseline orthostasis (documented drop in sbp ≥ 20 mmhg or in dbp ≥ 10 mmhg within 3 minutes after standing) at screening or baseline evaluations. * psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the mini. * significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or qtc prolongation on baseline ekg (\> 450 msec). * uncontrolled narrow angle glaucoma. * history of seizures. * use of mao inhibitor drugs within the last 14 days. * abnormal baseline liver or renal function tests. * dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol. * obstructive uropathy in males.
dapagliflozin therapy in cardiac surgery

Conditions: Diabetes Mellitus, Type 2; Cardiac Surgery

Summary: this randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

sodium-glucose cotransporter 2 inhibitor(sglt2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(t2dm). in recent studies, sglt2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. patients with t2dm have poorer cardiac surgery outcomes compared with non-diabetics. based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with t2dm. this randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at screening 2. scheduled for cardiac surgery 3. diagnosis of type 2 diabetes 4. provision of signed informed consent prior to any study specific procedures exclusion criteria: 1. emergency surgery and non-primary surgery 2. moderate and severe dehydration; systolic pressure≤90mmhg; unstable haemodynamics 3. history of diabetic ketoacidosis; type 1 diabetes mellitus 4. receiving therapy with an sglt2 inhibitor within 4 weeks prior to enrolment 5. known allergy or hypersensitivity to dapagliflozin or other sglt-2 inhibitors 6. estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation 7. serious hepatic disease 8. women who are pregnant, nursing, or who plan to become pregnant while in the trial 9. currently enrolled in another investigational drug study, or less than 30 days

Keywords: sglt2 inhibitors cardiac surgery diabetes mellitus
risk factors for colorectal cancer in patients with inflammatory bowel disease undergoing surveillance: a prospective cohort study

Conditions: Inflammatory Bowel Disease; Colorectal Cancer

Summary: both ulcerative colitis and crohn's colitis are associated with an increased risk of developing colorectal cancer (crc). although the increased risk of crc in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. recently, several of these risk factors were implemented in the updated british guidelines for surveillance which are now used to determine surveillance intervals in our center. the new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for ibd (inflammatory bowel disease) -associated crc are solely based on retrospective studies. prospective data on the phenotype and genotype reliably predicting the risk of crc is needed to further optimize surveillance in the future. objectives: 1. to confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of ibd patients undergoing regular surveillance. dysplasia or colorectal cancer will be the primary outcome. 2. to provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in ibd patients and that this is associated with 5-asa (5-aminosalicylic acid) or anti-tnf (tumor necrosis factor) maintenance therapy. 3. study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.


Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis * disease duration ≥ 8 years * inflammation of at least 30% of colonic mucosa at some point between ibd diagnosis and inclusion * age 18 - 70 years * signed informed consent exclusion criteria: * high grade dysplasia or colorectal cancer before inclusion * subtotal or total colectomy before inclusion * clotting disorder or use of anticoagulants that can not be temporarily discontinued * serious comorbidities which prevent performing a colonoscopy * limited life expectancy * clinical or endoscopical disease activity (at the discretion of the treating physician)

Keywords: ibd colitis dysplasia colorectal cancer
high protein diet in patients with long-chain fatty acid oxidation disorders

Conditions: Very Long-chain Acyl-CoA Dehydrogenase Deficiency; Trifunctional Protein Deficiency; Carnitine Palmitoyltransferase 2 Deficiency; Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency

Summary: the study also determines if eating a diet higher in protein alters body composition, energy balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.

at baseline, the amount of muscle and fat in the whole body and inside the liver and muscle will be measured. all subjects will complete a moderate treadmill exercise test and a test to determine how they use sugar (oral glucose tolerance test). the amount and type of energy burned by each subject will be measured. subjects will be randomly assigned to follow either a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. at the end of 4 months, the tests will be repeated.

Eligibility criteria:
inclusion criteria: * diagnosis of a long-chain fatty acid oxidation disorder including vlcad, cpt2, lchad or tfp deficiency * 7 years old or greater * able to comply with diet guidelines exclusion criteria: * pregnant * enrolled in another study that alters diet composition * cannot complete treadmill exercise study

Keywords: fatty acid oxidation disorders
phenylephrine versus tranexamic acid to control bleeding in patients undergoing inferior turbinoplasty by coblation

Conditions: Intraoperative Bleeding; Coblation Turbinoplasty

Summary: coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. it induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. the volume reduction and tissue fibrosis are immediate and sustainable. bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. in this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i and ii * scheduled patients for coblation turbinoplasty surgery with inferior turbinate hypertrophy exclusion criteria: * known allergy to study drugs. * history of coagulopathy or bleeding disorders. * patients with hypertension or ischemic heart disease. * patients on anticoagulants, antiplatelets or nsaids * history of deep vein thrombosis, stroke or peripheral vascular disease.
corticosteroid vs. amniotic fluid injections in patients with trigger finger

Conditions: Stenosing Tenosynovitis

Summary: the proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. adverse events were extremely rare and not related to study participation. given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. this study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient is diagnosed with stenosing tenosynovitis exclusion criteria: * patient is less than 18 years of age * pregnancy * enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.

Keywords: corticosteroid
pre-procedural anxiety and sedation.

Conditions: Anxiety

Summary: colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. it is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. such fears can result in anxiety that may decrease the tolerance and cooperation of the patient, limit the success of the procedure, and increase the likelihood of complications. therefore, colonoscopy is frequently performed under sedation. the anxiety level of the patient before the procedure may increase the requirement for sedation. it is important for the anesthesiologist to predict the effective dosages of sedation before the procedure to ensure rapid and comfortable sedation as well as prompt recovery and discharge of the patient. this prospective cohort study is planned to evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.

patients scheduled for elective colonoscopy for screening are enrolled. on the day of the procedure, demographic data are collected and all patients are asked to complete the spielberger state-trait anxiety inventory (stai-i and stai-ii) in an isolated, calm room before being transferred to the procedure room. all patients are monitored with electrocardiogram, pulse oximetry, noninvasive blood pressure and bispectral index measurement at 5-min intervals. oxygen is administered at 4 l/min via a face mask, propofol 2% infusion is started via an effect-site target controlled infusion system (marsh model). once the patient reaches the desired level of sedation as determined by bis value of 60, the procedure is started. this monitorization and sedation protocol is the routine management of outpatient colonoscopies and gastroscopies in our institution. for this study the patients' anxiety levels are evaluated with the stai score. this is not an intervention but an evaluation of the patients. drug dosing or sedation management are not adjusted according to the anxiety scores but are calculated with the patients' weight. during the procedure: * hemodynamic parameters * the total propofol dosage * the number of tci interventions * complications (respiratory depression, need for ventilation, nausea, vomiting, laryngospasm, and agitation) * the procedure duration * surgeon satisfaction with sedation instrument scores are recorded. these collected data are studies to determine a correlation between the propofol dose and the pre-procedural anxiety of the patients.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiology physiologic assessment score i-ii patients * 18-65 years old * planned elective colonoscopy under sedation exclusion criteria: * the use of anxiolytic medications * history of colonic resection or any intraabdominal surgery * predicted allergy to propofol * patients refusing sedation

Keywords: colonoscopy deep sedation anxiety
study of travatan in subjects with iris pigmentation changes

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. to be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with travatan.


Eligibility criteria:
inclusion: * diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension; * has experienced an iris pigmentation change while dosing with travatan; * currently dosing with travatan; * other protocol-defined inclusion criteria may apply. exclusion: * any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension; * not currently using travatan; * females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures; * history of any severe ocular pathology (including severe dry eye); * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension primary open-angle glaucoma iris pigmentation
uk andromeda-shock-2 rct

Conditions: Septic Shock

Summary: the purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care.

septic shock is a life-threatening condition caused by a severe infection. it can rapidly cause multi-organ failure and is associated with a high risk of dying. patients with septic shock need emergency treatment with intravenous fluids, antibiotics and medications to improve blood supply to all organs. however, it is clear that giving too much fluid is harmful and giving not enough fluid can make organ failure worse, too. international guidelines exist but there is still a lot of variation in how doctors apply the guideline. further, it is likely that a "one-size-fits-all" approach does not help all patients. previously, the andromeda-shock 1 trial showed that resuscitation guided by regular monitoring of skin perfusion was associated with a lower risk of dying than resuscitation guided by regular blood tests. the uk andromeda-shock-2 rct builds on this. the aim is to investigate whether an individualised approach based on monitoring of skin perfusion combined with individualised treatment of the blood pressure and circulation for 6 hours is better for patients with septic shock and reduces the risk of organ failure and dying compared to usual care. during the study period, the investigators will also take a total of 40ml of blood and 60ml of urine for special kidney tests to evaluate kidney health and recovery of kidney function. after the study has finished, the investigators plan to share fully anonymised results with the investigators of the international andromeda shock 2 trial to get as much information as possible to answer the research question and help patients in future.

Eligibility criteria:
inclusion criteria: consecutive adult patients (≥ 18 years) with septic shock defined by sepsis-3 consensus criteria. (ie septic shock defined as suspected or confirmed infection, hyperlactatemia and noradrenaline requirement, after a fluid load of at least 1000ml in 1 hour) exclusion criteria: any of the following criteria preclude participation to the trial: 1. more than 4 hours since septic shock diagnosis, 2. surgery or acute renal replacement therapy anticipated to start during the 6h intervention period 3. active bleeding, 4. child b-c cirrhosis 5. underlying disease process with a life expectancy \<90 days 6. attending clinician deems aggressive resuscitation unsuitable 7. refractory shock (high risk of death within 24h) 8. pregnancy 9. concomitant severe acute respiratory distress syndrome 10. capillary refill time cannot be accurately assessed