Kornimate/medical-research-clean huggingface dataset:
dialysis adequacy in nutritional status in hemodialysis patients

Conditions: Dialysis Adequacy

Summary: assess nutrition status in hemodialysis patients and effect adequacy of hemodialysis on it. effect of dialysis adequacy and nutritional status in patients' quality of life.

patients with end-stage renal disease (esrd) are unable to sustain life without hemodialysis. so, adequacy of hemodialysis is the main treatment for this patient. adequacy of hemodialysis can be appeared on patient clinically by improve quality of life and life expectancy, increase appetite and weight gain, control blood pressure, no bone disease, control of acidosis and anemia, relief of uremic symptoms as nausea, vomiting, fatigue, anorexia, weight loss, muscle cramps, pruritus, or changes in mental status. malnutrition is a major issue in patients undergoing hemodialysis and is observed in approximately 20% - 70% of this group. malnutrition is a serious predictive factor for mortality and morbidity accompanied by an increase in the rate of hospitalization, less physical activity, lower quality of life. an imbalance between energy and protein gain and food metabolism, metabolic acidosis, dietary restrictions, anorexia and poor appetite, protein and nutrient loss during dialysis, underlying diseases, such as cardiovascular problems, infection, poor nutrition management, inadequate dialysis, etc. are among influencing factors on the nutrition of hemodialysis patients. among patients undergoing hemodialysis, 6% to 8% suffer from severe malnutrition and 30% - 65% from mild malnutrition. the results of some studies have shown that one of the important causes of malnutrition is low dialysis adequacy in patients undergoing hemodialysis. malnutrition is associated with an increase in morbidity, a decrease in functional capacity, and a greater number and duration of hospital admissions, all of which may cause a low health-related quality of life (qol) and impact patients' emotional, physical, and psychosocial health.

Eligibility criteria:
inclusion criteria: 1. patients in regular haemodialysis . 2. patients above 18 years exclusion criteria: 1. patients with thyroid illness. 2. patients with acute infection. 3. patients with major surgeries. 4. patients with malignancy. 5. patients with liver cirrhosis. 6. patient with inflammatory bowel diseases.
a multi-center study evaluating the onset and duration of action of ac-170 0.24% compared to vehicle in the conjunctival allergen challenge (cac)

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the onset and duration of action of ac-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (cac) model.


Eligibility criteria:
inclusion criteria: * positive bilateral conjunctival allergen challenge (cac) reaction exclusion criteria: * known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study
covid-19 : transcutaneous po2 and pco2 as predictive factors for acute respiratory destress syndrome in patients affected with sars-cov-2

Conditions: COVID; Acute Respiratory Distress Syndrome; Endothelial Dysfunction

Summary: the first case of a person infected with sars-cov-2 virus can be tracked back on november the 17th, 2019, in china. on march 11, 2020, the world health organization (who) declared covid-19 outbreak a pandemic. on april 13, covid-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. the real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested. the percentage of patients with covid-19 needed for intensive care unit (icu) varied from 5 to 32% in wuhan, china. it was up to 9% in lombardy, italy. according to available data from lombardy, 99% of patients admitted to the icu needed respiratory support (88% invasive ventilation, 11% non invasive ventilation). the aim of the present investigation is to test the hypothesis whether transcutaneous partial o2 and co2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ards) development in hospitalized clinically stable covid-19 positive patients and to clarify the role of the angiotensin converting enzyme 2 (ace2) and its final product, angiotensin 2 (ang ii) in the pathogenesis of this systemic disease. we also aim to test the hypothesis that plasma concentration of clara cell protein (cc16) and surfactant protein d (spd), which are a biomarkers of acute lung injury, are severely decreased in covid-19 positive patients and the plasma concentration is related to the severity of lung injury.


Eligibility criteria:
inclusion criteria: * sars-cov2 infection (pcr positive and/or tdm imaging) exclusion criteria: * none
smoking cessation pilot for people living with hiv (plwh)

Conditions: Smoking Cessation; Smoking; Smoking Behaviors; Smoking Reduction; Smoking, Tobacco; Smoking, Cigarette; Hiv; HIV/AIDS

Summary: the overall goal of this pilot study is to evaluate the feasibility of the lumme smartphone app for smoking cessation in people living with hiv (plwh) and evaluate its effect on smoking cessation. mobile health (mhealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. therefore, a mhealth intervention such as the lumme app proposed through this study is timely, relevant, scalable and likely to improve health outcomes in plwh who smoke.

of the approximately one million persons living with hiv (plwh) in the united states (u.s.), it is estimated that between 34-47% smoke cigarettes, around three times the prevalence (12.5%) observed in the general u.s. adult population. consequently, plwh experience substantial tobacco-related morbidity and mortality. in plwh, after achieving and maintaining a suppressed viral load, smoking cessation is the next most important health behavior to maximize both quality of life and life expectancy. given the high prevalence of cigarette smoking among plwh and the benefit of smoking cessation, there is an urgent need for swift action to intervene to reduce tobacco use rates. however, evidence to improve tobacco cessation among plwh is inadequate. given the need for improving smoking cessation in plwh, and the great promise of mhealth tools, this research study will assess smoking behaviors in people living with hiv and the subsequent efficacy of mhealth intervention for improving tobacco cessation.

Eligibility criteria:
inclusion criteria: * plwh * ≥ 18 years old * own an android smartphone * understand and read english * not pregnant or breastfeeding * permanent contact information * smokes greater than or equal to 5 cigarettes per day for the past 30 days * interested in quitting smoking within 30 days * blow ≥ 6 carbon monoxide (co) into a breath analyzer at baseline exclusion criteria: * self-report being hiv-negative or unknown status * pregnant, breastfeeding, or planning to become pregnant during the study period * planning to move within 3 months of enrollment * a positive history of a medical condition that precludes use of the nicotine patch * current use of nicotine replacement therapy or other smoking cessation medications * current enrollment in another smoking cessation program * blows ≤ 5 co into a breath analyzer at baseline.

Keywords: smoking smoking cessation smoking behaviors smoking reduction tobacco cigarette plwh hiv hiv/aids mhealth mobile health lumme pilot
trial of pregabalin, alprazolam, and placebo in subjects with anxiety prior to dental procedure

Conditions: Dental Anxiety

Summary: the primary purpose of the trial is to assess how effective pregabalin, alprazolam, and placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4 hours before a scheduled dental procedure.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years of age or older who score 12 points or more on the dental anxiety scale at screening and baseline evaluations and have a scheduled appointment for an elective dental procedure. exclusion criteria: * current diagnosis of any of the dsm-iv anxiety disorders. * current diagnosis of major depressive disorder, dysthymia, schizophrenia or any other psychotic disorder, bipolar disorder, and eating disorders as assessed by the m.i.n.i. at screening, or current diagnosis of delirium, dementia, or body dysmorphic disorder.
sepreven: a stepped-wedge randomised controlled trial

Conditions: Intensive Care Units, Neonatal; Misadventures to Patients During Surgical and Medical Care; Catheter-related Bloodstream Infection (CRBSI) Nos; Quality of Healthcare; Ventilator Adverse Event; Nosocomial Pneumonia; Immature Newborn; Skin Lesion; Extravasation Injury; Nasal Injury; Intubation Complication; Medication Administered in Error; IV Catheter Nos Deep Venous Thrombosis

Summary: adverse events are frequent in neonatal intensive care units' (nicu) patients and account for a high morbidity and mortality. possible severe adverse events are central line associated bloodstream infections (clabsi), ventilator and catheter associated adverse events and medication errors. severity of the patient's outcome after an adverse event can be classified using the national coordinating council for medication error reporting and preventing (ncc merp) index for categorizing medication errors. the study will test the hypothesis that rates of adverse events in nicu patients will be reduced by the implementation of an educational program for the nicu caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. these strategies will be oriented to prevent clabsi, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events. this trial has a stepped wedge cluster design, in which the nicus from 12 hospitals in france will be randomized to the timing of implementation of the educational program. in order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. a nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons). the rates of adverse events will be measured retrospectively using a neonatal nicu trigger tool.


Eligibility criteria:
inclusion criteria : * patients hospitalized during the study period in one of the 12 participating neonatal intensive care units * corrected gestational age not exceeding 42 weeks +6 days at the time of admission in the nicu * length of hospitalisation in the nicu \> 2 days * no parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information exclusion criteria: * more than 42 weeks +6 days of corrected gestational age on admission in the nicu * length of hospitalization in the nicu \< or = 2 days * parental objection to the anonymous data collection of their newborn(s)' clinical data

Keywords: adverse event neonatal intensive care unit catheter-related bloodstream infection (crbsi) nos extravasation injury medication error central venous catheter complication unprogrammed extubation
dosing chart for calculating the first dose of doxapram in premature infants

Conditions: Premature Infants; Apnea

Summary: doxapram is used to stimulate respiration. for a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. two factors are linked to these fluctuations: age and gender. the aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.

doxapram is a drug used to stimulate respiration in neonates prematurely born and failing to breathe. for a given dose, the fluctuations in concentrations of drug observed in infants' blood might be wide, leading to a risk of lack of efficacy of the treatment or of toxic effects. two factors are linked to these fluctuations: age and gender. the aim of our study is to compare a dosage regimen based only on patient's weight, and another one using a dosing chart taking into account not only weight but also age and gender to prescribe the initial dose of doxapram. the final goal of this trial is to improve efficacy and tolerance of doxapram by minimizing the fluctuations in blood drug levels in premature neonates.

Eligibility criteria:
inclusion criteria: * premature infants (\<37 weeks gestation) * more than 1 significant apnea q 8h (\> 20 sec or \< 20 sec with bradycardia or desaturation) * already treated with caffeine exclusion criteria: * intubation * congenital malformation * symptomatic apnea

Keywords: premature infants apnea doxapram pharmacokinetics
a real-world study of tafasitamab in combination with lenalidomide in patients withr/r dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: to evaluate the real-world efficacy of tafasitamab combined with lenalidomide base regimen in patients with relapsed or refractory dlbcl, with objective response rate as the primary end point.

this study retrospectively collected the data of patients previously treated with tafa and divided them into two coords according to different protocols received. cohort 1 was tafa combined treatment group, which could include tafa combined with lenalidomide, tafa combined with lenalidomide plus btk inhibitor, tafa combined with lenalidomide plus chemotherapy (including adc). cohort 2 was treated with sequential car t or graft after tafa combination therapy.

Eligibility criteria:
inclusion criteria: * patients with pathological diagnosis of dlbcl, including but not limited to non-specific dlbcl (nos-dlbcl); large b-cell lymphoma (thrlbcl) rich in t cells/histiocytes; ebv positive dlbcl (ebv-positive dlbcl); according to the revised real/who classification, it was grade 3b follicular lymphoma, including dlbcl component, followed by dlbcl recurrence. in addition, patients with low-grade lymphomas such as follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia have histological evidence of transformation to dlbcl and subsequent recurrence * patients who, as determined by the treating physician, would benefit from tafa treatment exclusion criteria: * known allergy or metabolic disorder to any drug in the regimen * those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period * have a history of uncontrolled medical disease (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency), blood, endocrine system, and other malignancies * severe mental illness * patients deemed unsuitable for inclusion by the investigator
a randomized trial to evaluate the effectiveness of transferring the flexor hallucis longus tendon

Conditions: Achilles Tendinopathy

Summary: the optimal surgical treatment for insertional achilles tendinopathy remains unclear. the purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of insertional achilles tendinopathy; achilles tendon debridement, excision calcaneal exostosis, strayer procedure, secondary repair of achilles with flexor hallucis longus (fhl) transfer and achilles tendon debridement, excision calcaneal exostosis, strayer procedure, secondary repair of achilles without fhl transfer.


Eligibility criteria:
inclusion criteria: * male and female 18 years or older * diagnosed with insertional achilles tendinosis by history and physical exam * confirmed by x-ray and mri * calcification at the achilles insertion and gastrocnemius tightness. * failure of the following non-operative treatment for greater than 6 months: \*shoe modifications * physical therapy * immobilization * and home exercise program. * in addition, participant must have an intact flexor hallucis longus tendon. exclusion criteria: * patients who have failed surgery for the same and patients with diabetic neuropathy.

Keywords: surgical treatment of insertional achilles tendinopathy
smart embedded intervention for military postsurgical engagement readiness

Conditions: Knee Pain Chronic

Summary: the overarching objective of this proposal is to conduct a multi-site sequential multiple assignment randomized trial (smart) across multiple military health system (mhs) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (tka) patients: a single-session mindfulness-based intervention (mbi) and an intensive 8-week mbi-mindfulness-oriented recovery enhancement (more) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. aim 1: evaluate the extent to which a brief preoperative mbi improves tka patients' postoperative musculoskeletal health and reduces chronic opioid use. aim 2: evaluate the extent to which an intensive mbi (more) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. aim 3: (a) determine patient baseline characteristics that moderate mbi treatment responses. (b) quantify the degree to which the impact of phase 1 and 2 mbis on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (hrv).


Eligibility criteria:
inclusion criteria: * scheduled to undergo unilateral total tka at one of the study sites * tricare beneficiary * facility with the english language that is adequate to complete study procedures. exclusion criteria: * cognitive impairment preventing completion of study procedures, * formal mindfulness training (e.g., mbsr, mbct) * severe, active suicidality * contralateral tka in the past 3 months or planned contralateral tka during the study * current cancer diagnoses.
sb-681323-methotrexate interaction study

Conditions: Arthritis, Rheumatoid

Summary: sb-681323 is a p38 map-kinase inhibitor that has potential uses in inflammatory conditions such as ra. previous p38 map-kinase inhibitors have been hindered in development by liver toxicity. methotrexate (common treatment for ra patients) also has potential liver toxicity. this study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function


Eligibility criteria:
inclusion criteria: * male or female. females must be of non-child-bearing capacity * bmi 19 - 30 kg/m2 (inclusive) * diagnosis of ra according to the revised 1987 criteria of the american college of rheumatology (acr) * negative urine drugs of abuse screen, breath alcohol tests, hepatitis b and c, and hiv tests. * liver function tests within normal limits * must be on a stable dose of methotrexate (2.5 - 25 mg/week) for \>8 weeks prior to enrolment and which will not be changed during the course of this study. * must be on stable folate supplements for \>8 weeks prior to enrolment with normal red cell folate levels at enrollment. exclusion criteria: * history of alcohol \&/or drug abuse * abnormal ecgs at screening * liver disease, uncontrolled hypertension, diabetes mellitus, psoriasis, history of peptic ulcer disease * the patient is using glucocorticoid at doses \>10mg/day. * the patient is using sulphasalazine at a dose \>3g/day. * the patient is using hydroxychloroquine at a dose \>400mg/day. * the patient is on treatment regimen of dmards other than mtx plus one or both of sulphasalazine and hydrochloroquine (e.g. leflunomide) * the patient dose of nsaids, cox-2 inhibitors or glucocorticoids change at any time during 2 weeks prior to enrolment until the end of the clinical phase of the study

Keywords: methotrexate, sb-681323, p38 map kinase inhibitor, liver function rheumatoid arthritis,
study evaluating the safety and efficacy of brimonidine tartrate ophthalmic solution in adult and geriatric subjects

Conditions: Ocular Redness

Summary: the purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects


Eligibility criteria:
inclusion criteria: * be at least 40 years of age * must have normal ocular health * must have history of redness relief drop use or desire to use exclusion criteria: * must not have any ocular/systemic health problems * must agree to avoid disallowed medications
a pilot trial to assess low-intensity ultrasound in osteoarthritis

Conditions: Osteoarthritis, Degenerative

Summary: the purpose of this exploratory trial is to investigate whether plius is potentially effective as a disease and symptom modifying intervention in patients with early knee oa.

osteoarthritis (oa), the most common form of arthritis, is a prevalent and debilitating disease without therapies that alter disease progress and is currently managed with symptom-modifying therapies that are only modestly effective. in spite of substantial progress in understanding the pathogenesis of oa, no effective disease modifying interventions have been established. degenerative joint cartilage is a central feature of oa, yet joint cartilage has a limited capacity for repair. results from animal research demonstrate that pulsed low intensity ultrasound (plius) mechanically stimulates, and may promote, cartilage repair. this exploratory trial will investigate whether plius is potentially effective as a disease and symptom modifying intervention in patients with early knee oa.

Eligibility criteria:
inclusion criteria: * 40 years of age or older, and a us military veteran * clinical symptoms of osteoarthritis for at least 6 months * pain in the index knee on motion or weight bearing for the majority of days during the month before screening * clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria * american rheumatism association functional class i, ii, or iii * females of childbearing potential must be willing to use a reliable form of medically acceptable contraception exclusion criteria: * concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy * spine or hip pain of significant magnitude * history of significant ligament or meniscal injury of the index joint requiring surgical repair * arthroscopy of the index knee within 6 months of study entry * unable to undergo mri of the knee * pregnancy or lactation * corticosteroid treatment within 1 to 3 months prior to study entry * intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry * use of excluded therapy(ies) prior to study entry * use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives * exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry * use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry * initiation of physical therapy or muscle conditioning program to the lower extremities within 2 months within 2 months prior to study entry * unlikely to comply with study requirements

Keywords: knee osteoarthritis pulsed low intensity ultrasound