Kornimate/medical-research-clean huggingface dataset:
effect of ciclosporin eyedrops on sjögren syndrome

Conditions: Dry Eye Syndromes

Summary: keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin a. in patients with rheumatological diseases, such as sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients. aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of severe keratoconjunctivitis sicca defined by: * staining of the cornea ≥ grade iii according to the oxford scale * osdi value ≥ 12 * age between 18 and 90 years * primary or secondary sjogren's syndrome (defined according to the american-european consensus group criteria) with a stable course and unchanged treatment for 6 months exclusion criteria: * pregnancy (excluded with a pregnancy test in patients of childbearing potential) * children and young people up to the age of 18 * eye surgery in the past 6 months * simultaneous participation in another study * regular use of eye drops, with the exception of tear substitutes * use of eye drops containing ciclosporin or glucocorticoids in the last 6 months
comparison of single-dose efficacy of an albuterol breath-actuated inhaler (albuterol-hfa-bai) versus an albuterol metered-dose inhaler (albuterol-hfa-mdi) in participants with asthma

Conditions: Asthma

Summary: this is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (hfa-bai) and albuterol-hfa-metered-dose inhaler (mdi) in asthmatics with poor inhaler coordinating abilities.


Eligibility criteria:
inclusion criteria: * asthma of a minimum of 6 months duration * participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the aerosol inhalation monitor (aim, vitalograph) prior to any training and following training in 3 consecutive attempts * reversible bronchoconstriction of \>12% increase in fev1 with a cumulative dose of 450 mcg of albuterol * the reversibility (fev1) of ≤70% following administration of the initial 90 mcg of albuterol * ability to perform spirometry reproducibly * ability to self-perform peak expiratory flow (pef) determinations and report scores on diaries * can tolerate withdrawal of applicable medications for qualification at screening * otherwise healthy individuals * non-smokers for at least 2 years prior to the screening visit exclusion criteria: * allergy or sensitivity to albuterol * exposure to investigational drugs within 30 days prior to the screening visit * continuous treatment with beta-blockers, monoamine oxidase (mao) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids * treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit * the prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit * inability to tolerate or unwillingness to comply with required washout periods for all applicable medications * hospitalization for acute exacerbation of asthma more than twice in past year * treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit * an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit * history and/or presence of any clinically significant non-asthmatic acute or chronic disease * known or suspected substance abuse * previous enrollment in an ivax research-sponsored albuterol-hfa asthma study note: other inclusion and exclusion criteria may apply.

Keywords: asthma and poor coordinators of asthma inhalers
secondary prevention and recidivism reduction in trauma patients

Conditions: Trauma; Alcohol Use, Unspecified; Drug Use

Summary: the consumption of alcohol and other drugs is one of the main risk factors for traumatism. in addition, patients who have suffered an accident in relation to the consumption of these substances present a high risk of recidivism. in the case of alcohol, its relationship with traumatisms has been known for many years now and is still one of the main risk factors. secondary prevention is an important area of action and improvement in the treatment of this type of patient by considering actions, such as a brief motivational intervention, in order to avoid recidivism. the objective of motivational intervention is to make the patient aware of the relationship between the consumption of these substances and the accident, and induce them to carry out a change in habits. the objective of the present investigation project is to determine the efficacy of secondary prevention in reducing recurrence of traumatisms. in order to this, a multicenter randomised controlled trial has been designed in which the intervention group with patients admitted for sever traumatism with positive screening for alcohol or other drugs, will be submitted to a brief motivational intervention. the main outcome will be trauma recurrence within a three year follow-up.


Eligibility criteria:
inclusion criteria: * sever trauma patients defined as the need of assistance in a critical unit. * positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine). exclusion criteria: * patients in treatment for abuse of alcohol and other drugs. * death during hospitalization. * non catalonia residents. * not spanish or catalan spoken.
study of pulmozyme to treat severe asthma episodes

Conditions: Asthma

Summary: even with current standard ed treatments 20-25% of patients presenting to the ed with an acute asthma episode will still require hospitalization. for patients unresponsive to beta-agonists the admit rates will be higher. of those well enough to be discharged from the ed nearly 30% will relapse within one month. more than 5,000 patients with asthma still die each year in the usa. for patients who do not respond to beta-agonists, there are relatively few treatment options for rapid improvement of symptoms and pulmonary function. presumably, mucous secretion and plugging play an important role in the pathogenesis of severe asthma unresponsive to beta-agonists. the use of agents to promote clearance of intra-luminal secretions and mucous plugs may represent an important advance in the management of acutely ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting and to prevent relapse after discharge from the ed. objectives 2.1 study hypothesis: rhdnase can be safely used in patients presenting to the emergency department with acute moderate-severe asthma who do not have adequate responses to beta-agonists project specific aim: this is a pilot study to determine the safety of three different doses of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ed with acute asthma. in addition to safety trends for improvement in pulmonary function and clinical outcomes will be monitored and data analyzed. based on the safety profile and observable responses to treatment, this information may be used to develop larger trials to determine the efficacy and dosing strategy for treating acutely ill asthmatics with rhdnase.


Eligibility criteria:
inclusion criteria: acute asthma fev1\<60% post-standard care age 18-55 years - exclusion criteria: other chronic lung illness pregnancy -

Keywords: acute disease
submerged vs. nonsubmerged single laser-microgrooved dental implants.

Conditions: Partially Edentulous Maxilla, Mandible

Summary: aim: to evaluate and compare radiographic marginal bone loss (mbl) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.

materials and methods: 20 submerged/two-stage implants and 20 nonsubmerged/one stage implants were placed randomly with a split mouth design, in 20 partially edentulous patients. radiographic and clinical examinations were carried out at the implant placement (baseline, bsl), at the delivery of prosthetic restorations (t0), and at each year of the follow-up period (t1, t2, t3). plaque index (pi), probing depth (pd), bleeding on probing (bop), and gingival recession (rec) were recorded. radiographic marginal bone levels (mbl) were assessed at the mesial (mi) and distal (di) aspect of implant sites. in addition, the influence of keratinized tissue thickness (ktt) on mbl was investigated.

Eligibility criteria:
inclusion criteria: inclusion criteria were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla. - exclusion criteria: * exclusion criteria were: implants placed into regenerated bone, lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (\> 10 cigarettes/day), full mouth plaque score (fmps), and full mouth bleeding score /fmbs) ≥25%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.

Keywords: submerged two-stage, nonsubmerged one-stage, dental implants, marginal bone loss
the comparison of warming techniques in patients undergoing open abdominal surgery in litotomy position

Conditions: Temperature Change, Body

Summary: the patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

the patients will be randomized into two groups. all patients will receive prewarming with forced-air warming device for 30 minutes. all patients will receive warmed fluids during intraoperative period. one group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. timpanic, esophageal and peripheral temperature monitoring will be performed.

Eligibility criteria:
inclusion criteria: * major abdominal surgery in litotomy position * asa i-ii * anticipated operation time over 1 hour exclusion criteria: * sepsis * hypothermia * hyperthermia * malignant hyperthermia * tyroid dysfunction
akin osteotomy with or without fixation

Conditions: Hallux Valgus

Summary: the study is a prospective randomized study about hallux valgus surgery. the investigator try to assess if the fixation of percutaneous akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

it's a prospective monocentric randomized work about forefoot surgery. every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous akin osteotomy of the first phalange. the investigators study the impact of the fixation of percutaneous akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous akin osteotomy, and one with a non-fixed percutaneous akin osteotomy this study as been approved by institutional review board; written informed consent is required for all patients before inclusion. the clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. this includes clinical exam, radiologic exam, and functional score aofas before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery. the primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.

Eligibility criteria:
inclusion criteria: * patient which need hallux valgus surgery exclusion criteria: * hallux rigidus * trouble of rotation of the the hallux * rheumatoid forefoot * pregnant women

Keywords: percutaneous non-fixed akin ; osteotomy
clinical outcome and cost-effectiveness of reduced noradrenaline by using a lower blood pressure target in patients with cardiogenic shock from acute myocardial infarction

Conditions: Cardiogenic Shock; Myocardial Infarction

Summary: rationale: pump failure due to acute myocardial infarction (ami) can lead to cardiogenic shock (cs): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. the first line pharmacologic treatment strategy in cs is noradrenaline. this vasopressor drug is used to maintain adequate blood pressures. the assumption is that a mean arterial blood pressure (map) ≥ 65 mmhg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). however, there is no evidence that an increase in map, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. objective: with this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with cs by using a lower map target of ≥ 55 mmhg, compared to ≥ 65 mmhg. the investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. study design: open label, randomized controlled multicenter trial study population: adults patients with cs due to ami intervention: treatment strategy of reduced noradrenaline, by using a lower map target ( ≥ 55 mmhg). main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.


Eligibility criteria:
inclusion criteria: 1. acute myocardial infarction, stemi or nstemi 2. early revascularization by pci 3. cardiogenic shock, characterized by: i. a. systolic blood pressure (sbp) ≤ 90 mmhg for \> 30 minutes, or b. use of drugs to maintain sbp \> 90 mmhg at randomization. ii. clinical signs of impaired organ perfusion with at least one of the following criteria: 1. altered mental status 2. cold, clammy skin and extremities 3. oliguria with urine output \< 30ml/hour 4. serum lactate \> 2.0 mmol/l iii. clinical signs of pulmonary congestion exclusion criteria: 1. resuscitation \> 30 minutes 2. mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture) 3. onset of shock \> 12 hours 4. imminent need for mechanical circulatory support

Keywords: noradrenaline blood pressure target cardiogenic shock myocardial infarction
efficacy and safety of ypeginterferon alfa-2b in hbeag positive chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is a multi-center, randomized, open-label and positive controlled phase ii clinical trial to assess efficacy and safety of ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis b characterized by hbeag positivity, with pegasys 180mcg/week as positive control. it is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of phase iii trials, and generate pharmacokinetic data of ypeginterferon alfa-2b in hepatitis b patients to satisfy regulatory requirements.


Eligibility criteria:
inclusion criteria: * age:18\~60 years. * pregnancy tests of female patients must be negative. all patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. * serum hbsag positive for at least 6 months. * serum hbeag positive with hbv dna ≥20,000iu/ml. * 2×uln≤alt≤10×uln at screening(uln=upper limit of normal). exclusion criteria: * pregnant or lactating women. * mental disorder or physical disability. * interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis b treatment within the previous 6 months. * wbc\<3000/mm3, or anc \<1500/mm3, or plt \<90,000/mm3. * co-infection with hav, hiv, hcv, hdv, hev. * both hbsag and anti-hbs are positive, or both hbeag and anti-hbe are positive at screening. * chest x-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. * evidence of hepatic decompensation. * history of hypothyroidism or current treatment for thyroid disease. * uncontrolled significant chronic medical conditions other than chronic hepatitis b, or other conditions which in the opinion of the investigator preclude enrollment into the study.

Keywords: peginterferon interferon pegasys hbv hepatitis b hbeag positive
corneal endothelial cell density changes, when mapracorat ophthalmic suspension 3%, is administered for 14 days

Conditions: Corneal Endothelial Cell Changes

Summary: the objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered qid (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.


Eligibility criteria:
inclusion criteria: * must have a pinhole visual acuity (va) equal to or better than 20/40 in both eyes. * must be in good ocular health exclusion criteria: * subjects who have known hypersensitivity or contraindication to the study drug or its components. * subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the disallowed therapy section of the protocol. * any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study. * subjects who are monocular (fellow eye is absent or fellow eye's pinhole va is worse than 20/200). * subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period. * presence of significant ocular or systemic disease that the investigator determines could interfere with the study.

Keywords: cornea endothelial cell density
the effect of uvb phototherapy with microneedling and circled needing in vitiligo patients

Conditions: Brief Description of Focus of Study Instead

Summary: vitiligo is a relatively common acquired disorder of pigmentation characterized by the development of well-defined white macules on the skin. biopsies of lesional skin reveal a loss of epidermal melanocytes. lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults . patients with vitiligo often experience stigmatization, social isolation, and low self-esteem. the therapys include topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery. the aim of this study is to investigate the effect of phototherpy and accupuncture combined therapy for vitiligo patients.


Eligibility criteria:
inclusion criteria: clinical diagnosis of vitiligo exclusion criteria: * pregnancy * immune disorder * infection * other dermatosis in treating areas
studies of biological changes related to weight loss after gastric bypass surgery

Conditions: Obesity; Morbid Obesity; Weight Loss

Summary: weight loss achieved by dieting induces multiple changes. these changes include a decrease in metabolic rate (the rate in which the body burns its calories), an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting. many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study.

while gastric bypass surgery (gbs) is known to be highly effective in achieving significant weight loss, it is also associated with other biologic changes that occur in the body when weight is lost. in this study, subjects undergoing gastric bypass surgery will be followed throughout the weight loss period. they will undergo four detailed medical evaluations to assess changes in several biological systems that occur in the body when weight is lost. the initial assessment will be performed before the surgery (testing period 1). after surgery is completed, subjects will attend clinic visits at the rockefeller university outpatient clinic. during these visits, weight and leptin levels will be monitored. two additional assessments will be performed during weight loss, when subjects lose 10% and 20% of their initial weight (testing periods 2 and 3 respectively). a final evaluation will be performed after weight is stabilized, about 18 months after the surgery is completed (testing period 4). each testing period will be performed over a 2 week period in an inpatient setting at the rockefeller university hospital. during testing periods subjects will undergo a series of metabolic, behavioral, hormonal, immune and molecular tests to evaluate changes that occur in the body after weight loss. subjects will receive monetary compensation for participating in the study.

Eligibility criteria:
inclusion criteria: * 18 - 65 years old * subjects approved for gastric bypass surgery exclusion criteria: * subjects not approved for gastric bypass surgery

Keywords: weight loss surgery gastric bypass surgery