Kornimate/medical-research-clean huggingface dataset:
effect of contact lenses on tear osmolarity in a controlled low humidity chamber

Conditions: Myopia; Dry Eye

Summary: the purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.


Eligibility criteria:
inclusion criteria: * age 18 to 70. * history of end-of-day or low-humidity dryness with contact lenses. * healthy eyes. * best-corrected visual acuity of 20/50 or better for each eye. * usable pair of eye glasses. * willing and able to attend required study visits. * sign informed consent. * other protocol-defined inclusion criteria may apply. exclusion criteria: * ocular or systemic allergies or diseases which might interfere with contact lens wear. * clinically significant ocular findings which would contraindicate contact lens wear. * unable to abstain from artificial tears or other ophthalmic drops for at least 7 days. * participation in another clinical study currently or within 30 days of study entry. * spectacle astigmatism of \>1.00 diopter. * other protocol-defined exclusion criteria may apply.
inpatient diabetes mellitus (dm) management with continuous glucose monitoring devices, a pilot study.

Conditions: Diabetes Mellitus

Summary: several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care, non-intensive care unit (non-icu) setting is associated with prolonged length of stay, increased mortality and an increased incidence of infections. randomized clinical trials in both the critical and the non-icu settings have shown that by improving glucose control there is a decrease in the incidence of infections, length of stay and inpatient health care costs. continuous glucose monitoring (cgm) systems have evolved as useful devices providing excellent clinical care in patients with diabetes mellitus (dm). these systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes. in this clinical trial the investigators propose to examine the clinical use of cgm in hospitalized patients with diabetes mellitus type 2 (dm2). cgm use may improve glucometric values and clinical outcomes in hospitalized individuals with diabetes mellitus type 2 (dm2). we use cgm devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station. half of the participants are placed on real time cgm (alarms turned on) and half of them are placed on blinded cgm values (alarms turned off). nursing staff will be notified when glucose is \<85 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.


Eligibility criteria:
inclusion criteria: * history of diabetes mellitus type 2 (dm2) on insulin exclusion criteria * patients that are expected to require a hospital stay ≤3 days * pregnant patients * subjects that have significant hyperglycemia or diabetic ketoacidosis (dka) that requires treatment with intravenous insulin infusion * patients receiving glucocorticosteroids in doses (equivalent) to ≥ 20 mg of hydrocortisone/day * any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study * patients that need hospitalization in the critical care (icu) setting. * history of diabetes mellitus type 1 (dm1)
weaning children from mechanical ventilation:computer-driven system versus usual care

Conditions: Respiratory Failure

Summary: the purpose of this study is to determine whether a computer-driven system (smartcare/ps) decreases weaning duration from mechanical ventilation when compared to usual care in children.

baseline data: all subjects included into this rct will undergo routine examination upon admission to the hospital. these examinations include physical, medical/medication history (on the last year for medical history and the last 3 months for medication history (if available), vital signs, radiologic data and laboratory tests. intervention: a pre-inclusion test (pressure support test) with a level of pressure support of ± 5 cmh2o of the p plateau, but no greater than 30 cmh2o (pressure-support level plus positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this ventilation mode; the test is repeated daily until positive. the test could be stopped before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate \> 40 breaths per minute and fio2 \> 60% in order to obtain pulse oxymetry ≥ 95%). the test is considered positive when, after 30 minutes, the patient remained clinically stable with a respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than 6 ml per kilogram of body weight within the authorized pressure-support range, with pulse oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60 percent. when the pressure-support test is positive, the patient is randomized either to arm 1 where the intervention is weaning with the support of smartcare/ps or to arm 2 where the intervention is weaning based on usual care. both group are ventilated with the same ventilator: evita xl.

Eligibility criteria:
inclusion criteria: * the attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously. * no vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (\< 5 µg/kg/min) * slight or no endotracheal tube gas-leakage (\[vti - vte\]/vti ≤ 20%) * mechanical ventilation with a plateau pressure ≤ 25 cmh2o over peep * peep ≤ 8 cmh2o * fio2 ≤ 60% in order to obtain pulse oxymetry ≥ 95% * paco2 \< 70 mmhg on the last blood gases * extubation not expected the day of inclusion exclusion criteria: * n/a

Keywords: mechanical ventilation automated weaning children
freedom: "pilot study of the feasibility and safety of resuming early walking after manual compression in patients treated for peripheral artery disease by endovascular technique involving retrograde femoral puncture"

Conditions: Peripheral Arterial Disease

Summary: over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. these devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures. according to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. finally, the use of these devices generates additional costs. the purpose of our study is to evaluate the feasibility and safety of manual compression before early resumption of walking in patients managed by conventional hospitalization for a diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5f guide catheter.


Eligibility criteria:
inclusion criteria: * age \> 18 years, * endovascular examination or treatment compatible with a 5f guide catheter * walking ability * patient affiliated with a social security scheme * patient's signed informed consent form exclusion criteria: * underage patient * patient of age, but under legal guardianship or care * contraindication to endovascular treatment * use of a 6f or greater guide catheter * morbidity contraindicating same-day walking * history of punctured open femoral triangle surgery * radial or humeral puncture * bilateral femoral puncture * anterograde femoral puncture * acute ischemia * anticoagulant treatment * allergy to elastoplast® type adhesive strips * life expectancy of less than one month * patient refusal to take part in the study * participation in another therapeutic trial * pregnant woman * patients who do not speak french, refusing or incapable of the follow-up proposed by the study
study with an autologous dermo-epidermal skin substitute for the treatment of full-thickness skin defects in adults and children

Conditions: Skin Wound

Summary: this phase ii trial aims to evaluate the efficacy and safety of ehsg-kf (synonym denovoskin) in comparison to meshed stsg in adults and children with full-thickness skin defects.

this multicentre phase ii clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed stsg.

Eligibility criteria:
inclusion criteria: * age: ≥1 years of age * large full-thickness defects that require coverage after excision of: scars, benign skin tumors (e.g. neurofibroma), melanocytic nevus (e.g. giant nevus), gender reassignment surgery, soft tissue defect after trauma, soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), flap donorsite (e.g. radial forearm flap) * minimal areas requiring coverage (not counting the head and neck area for study patients in the netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2 * signed informed consent exclusion criteria: * patients tested positive for hbv, hcv, syphilis or hiv * patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (child-pugh class b or c), severe malnutrition, or other concomitant illness which, in the opinion of the investigator, has the potential to significantly delay wound healing) * severe drug and alcohol abuse * pre-existing coagulation disorders as defined by inr outside its normal value, ptt \>uln and fibrinogen \<lln prior to the current hospital admission and / or at the investigator's discretion * patients with known allergies to amphotericin b, gentamicin, penicillin, streptomycin, or bovine collagen * previous enrolment of the patient into the current phase ii study * participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study * patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) * pregnant or breast feeding females * intention to become pregnant during the clinical course of the study (12 months) * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: scar skin wound healing tissue engineering dermis epidermis
a study for hsk44459 in participants with atopic dermatitis

Conditions: Atopic Dermatitis (AD)

Summary: the purpose of this study is to assess the efficacy and safety of hsk44459 in adults with atopic dermatitis

this is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of hsk44459 in adult participants with atopic dermatitis.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained * male or female, ≥18 years old and ≤75 years old * willing and able to comply with study-specific procedures and the requirements of this study protocol. * atopic dermatitis has been present for at least 1 year and subject meets hanifin and rajka criteria * easi score≥16 at the screening and baseline visits * iga score≥3 at the screening and baseline visits * ≥10% body surface area (bsa) of ad involvement at the screening and baseline visits * baseline wi-nrs≥4 * history of inadequate response to tcs of medium to higher potency (with or without topical calcineurin inhibitors \[tci\]) or systemic treatment for ad within 6 months prior to screening * have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit exclusion criteria: * subjects have used ad treatments within the time frame specified in protocol prior to the baseline visit * prior exposure to any pde4 inhibitor systemic treatment * systemic use of known strong cyp3a inhibitors or strong cyp3a inducers within 4 weeks or 5 half-lives prior to randomization or during the course of the study * participation in other clinical studies within 4 weeks or 5 half-lives prior to randomization * subjects have laboratory values meeting the criteria in protocol * presence of skin comorbidities that may interfere with study assessments * concurrent conditions and history of other diseases as described in protocol

Keywords: atopic dermatitis
effects of 3 day preoperative immunonutrition in well-nourished patients with gastrointestinal (gi) cancer undergoing surgery

Conditions: Gastrointestinal Cancer

Summary: major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. it has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.the pre-operative regimen was between 5 to 7 days of treatment. the aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.


Eligibility criteria:
inclusion criteria: * patients with gi cancer (stomach, pancreas, small and large bowel and rectum) histologically proven * well nourished patients as defined by a total score of \<3 on the nutritional screening tool nrs-2002 (46) (appendix iii) * patients who are \>= 18 years of age; * patients who have signed a written informed consent (appendix i) prior to admission to the study; * patients who have an ecog performance status of 0, 1 or 2 (appendix ii). * patients able to orally consume 750 ml or more of liquid a day prior to surgery exclusion criteria: * patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult; * patients who are pregnant; * patients with cardiac failure as defined by the goldman classification class\>3 * patients with respiratory failure (fev\<0.8l/sec) * patients with renal failure (cr \>= 3mg/dl or dialysis patients) * patients with hepatic dysfunction (child \>a) * patients suffering from an intestinal obstruction or ileum * patients with an hb level of \<=8 g/dl experiencing gastrointestinal hemorrhaging * patients with hiv, hcv, hbv * patients requiring immunosuppression treatments * patients undergoing emergency surgery * other patients determined by a study investigator to be inappropriate for enrolment in this study

Keywords: immunonutrition cancer gi cancer surgery
comprehensive study of social representation of platelet transfusion in patients followed for advanced hematological malignancies (r-plq)

Conditions: Platelet Transfusion; Hematological Malignancy; Palliative Care

Summary: limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients. thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. as it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation. the final decision is take by the clinician and his patient, but no study exist in representation of the two parts. we provide a qualitative study to understand what this decision is made of.


Eligibility criteria:
inclusion criteria: * major patient * patient with advanced hematological malignancies * patient transfused in platelet regularly (3 time at least in last month) * medical practioner, hematologist, prescribing platelet transfusion at least one per week. * nurse working in hematology, practicing platelet transfusion at lest one peer week. exclusion criteria: * minor patient * non communicant patient * non transfused platelet patient * non voluntary patient or hematologist or nurses * non graduated hematologist

Keywords: social representation
observational epidemiological study of patients suffering from systemic amyloidosis

Conditions: Cardiomyopathy

Summary: observational epidemiological study of patients affected by systemic amyloidosis


Eligibility criteria:
inclusion criteria: * patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene * minimum age of 18 years at the time of diagnosis * obtaining informed consent exclusion criteria: * nothing

Keywords: cardiac amyloidosis
treating tobacco dependence in inpatient psychiatry - 1

Conditions: Tobacco Use Cessation; Tobacco Use Disorder

Summary: the purpose of this study is to test in a randomized clinical trial a series of hypotheses concerning the efficacy of an extended expert-system intervention plus nicotine replacement therapy (nrt) for treating tobacco dependence among patients hospitalized on a smoke-free psychiatric unit.

it is hypothesized that the intervention will be more effective than the enhanced standard care control condition (on-unit nrt with self-help brochure) in producing biochemically verified abstinence from cigarettes at 3-, 6-, 12-, and 18-months follow up. additionally, intervention participants will exhibit greater stage progression, commitment to abstinence, and delay in relapse to smoking following hospital discharge, factors predictive of future success with quitting smoking. smoking cessation treatments have been shown to be highly cost-effective with the general population of smokers, and cost is likely to be a consideration in efforts to incorporate additional services into an inpatient psychiatric setting. therefore, a secondary specific aim is to model the cost-effectiveness of the smoking cessation intervention. intervention efficacy will be examined in a university-based psychiatric inpatient unit. a smaller pilot study will examine translation of the intervention to a county hospital serving a more diversified patient population.

Eligibility criteria:
inclusion criteria: men and women over 18 years of age hospitalized on an inpatient psychiatric unit who report smoking at least 5 cigarettes per day; smoking at least 100 cigarettes in one's lifetime, residing in the san francisco bay area with no plan to relocate outside of the area in the next 18 months, and access to a telephone for scheduling follow up assessments. exclusion criteria: dementia or other brain injury precluding ability to participate; non-english speaking; severe agitation, psychosis, or hostility; and medical contraindications to nicotine replacement therapy (nrt). recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms. medical contraindications are: myocardial infarction in the preceding 3 months, unstable angina pectoris, liver or kidney disease, current pregnancy or breast feeding, allergies to adhesives, or other medical conditions that the medical team deems incompatible with nrt use.

Keywords: tobacco
a trial investigating the pharmacokinetic properties of fiasp in japanese subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in japan. the aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of fiasp (faster-acting insulin aspart) and the currently marketed insulin aspart (novorapid®) in japanese subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer * body mass index (bmi) 18.5-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
safety and efficacy study of copaxone administered in combination with minocycline

Conditions: Relapse Remitting Multiple Sclerosis

Summary: this study investigates the add-on effect of oral minocycline in subjects treated with daily injection of copaxone. copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating ms symptoms.


Eligibility criteria:
inclusion criteria: 1. clinically definite ms as defined by poser et al. (ann. neurol. 1983) with disease duration (from onset) of at least 6 months. 2. subjects must have a relapsing-remitting disease course. 3. subjects must have had at least 1 documented relapse within the last year prior to study entry. 4. subjects must have at least 1 and not more than 15 gadolinium (gd)-enhancing lesions on the screening mri scan. 5. subjects must be relapse-free and not have taken corticosteroids (iv, im and/or po) within the 30 days prior to the screening visit. 6. subjects may be male or female. women of child- bearing potential must use a contraceptive method deemed reliable by the investigator. 7. subjects must be between the ages of 18 and 50 years inclusive. 8. subjects must be ambulatory, with a kurtzke edss score of between 0 and 5.0 inclusive. 9. subjects must be willing and able to give written informed consent prior to entering the study. exclusion criteria: 1. previous use of injectable glatiramer acetate. 2. previous use of cladribine. 3. previous use of immunosuppressive agents in the last 6 months. 4. use of experimental or investigational drugs, including i.v. immunoglobulin and statins, within 6 months prior to study entry. 5. use of interferon agents or minocycline within 4 months prior to the screening visit. 6. chronic corticosteroid (iv, im and/or po) treatment (more than 30 consecutive days) in the 6 months prior to study entry. 7. previous total body irradiation or total lymphoid irradiation (tli). 8. pregnancy or breast feeding. 9. subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits. 10. significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). 11. a known history of sensitivity to mannitol. 12. contraindication to or known history of sensitivity to tetracyclines. 13. a known history of sensitivity to gadolinium. 14. inability to successfully undergo mri scanning.