Kornimate/medical-research-clean huggingface dataset:
multi-center evaluation of the nemo gauge to aid in correct positioning of the endotracheal tube

Conditions: Respiratory Failure

Summary: the aim of this study is to verify the safety and accuracy of an fda-approved device called the nemo™ gauge to aide in the proper positioning of the endotracheal tube (ett), inserted in the lungs of patients admitted to the intensive care unit. the hope is that the nemo™ gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). the study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the inland empire of southern california, with subjects being enrolled at loma linda university medical center, riverside university medical center and loma linda veterans affairs hospital.


Eligibility criteria:
inclusion criteria: 1. adult patients ≥ 18 years of age admitted to the intensive care unit (icu) 2. patients who have been intubated or at high risk of being intubated, requiring confirmation of ett position after intubation as determined by the clinical team 3. endotracheal tube size 7.0 mm to 8.5 mm in diameter exclusion criteria: 1. patients with active hemoptysis 2. patients with known tracheal or bronchial masses prior to endotracheal intubation 3. patients with known tracheal or bronchial abnormalities requiring surgical repair
a study of intravenous mircera for the correction of anemia in dialysis patients.

Conditions: Anemia

Summary: this 2 arm study will evaluate the efficacy of intravenous mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. patients will be randomized to receive either mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period. exclusion criteria: * previous therapy with epoetin within 8 weeks prior to screening; * overt gastrointestinal bleeding within 8 weeks before screening or during screening period; * rbc transfusions within 8 weeks before screening or during screening period; * active malignant disease except non-melanoma skin cancer.
amg 761 in adults with asthma

Conditions: Asthma

Summary: the purpose of this study is to determine that no significant safety issues will be identified following a single dose of amg 761 in asthma subjects that would preclude further development of amg 761.


Eligibility criteria:
inclusion criteria: * healthy, with no history or evidence of clinically relevant medical or psychiatric disorders (with the exception of asthma) as determined by the investigator in consultation with the amgen physician where medically appropriate * immunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/tdap), pneumococcal (polysaccharide), influenza (during flu season) and h1n1 (where and when available) vaccinations, as determined by the principal investigator * body mass index (bmi) in the range of 18 to 35 kg/m2, inclusive * is a current non-smoker and has not used any tobacco products within the last 6 months and the cumulative smoking history must be ≤ 10 pack years * clinically stable with a physician diagnosis of asthma for a minimum of 6 months prior to enrollment, and with no change in asthma treatment for at least 3 months prior to enrollment. as needed beta-agonist use (ie, prn) should be considered a stable treatment * documented history of atopy to oak, mite, ragweed, timothy grass, alternaria mold, kochia pollen, aspergillus, or cottonwood within 18 months or positive atopy skin prick test for these specific allergens during the screening period * additional inclusion criteria apply exclusion criteria: * past history of serious skin rash requiring hospitalization * active, or history of (within 12 months of enrollment), acute viral infection of the skin (eg, herpes simplex, herpes zoster, or molluscum contagiosum) * active or history of psoriasis, or a first degree relative with active or known history of psoriasis * first degree relatives with active or history of systemic lupus erythematosus or type 1 diabetes, rheumatoid arthritis or other active autoimmune disorder, as determined by the principal investigator * history of life-threatening anaphylaxis * experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room, hospitalization, or an episode treated with oral corticosteroids in dosage of at least 5 mg/day prednisone or equivalent for ≥ 1 week) during the 6 months prior to enrollment * additional exclusion criteria apply

Keywords: asthma
efficacy and safety of s (+) - ibuprofen in the treatment of mechanical low back pain

Conditions: Low Back Pain, Mechanical; Low Back Pain; Acute Low Back Pain

Summary: the purpose of this study is to evaluate the efficacy of s (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.


Eligibility criteria:
main inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * patient with acute low back pain who responds to the pain period less than or equal to 3 days; main exclusion criteria: * known hypersensitivity to the formula components used during the clinical trial; * previous history of alcohol or drugs abuse diagnosed by dsm-v; * current or previous history (less than 12 months) of smoking; * have clinically relevant abnormal laboratory results according to medical evaluation; * women who are pregnant, lactating, or positive for β - hcg urine test.

Keywords: pain control low back pain pain relief ibuprofen inflammation anti-inflammatory
piezo-surgery technique and intramuscular dexamethasone injection to reduce postoperative pain after impacted mandibular third molar surgery

Conditions: Impacted Mandibular Third Molar Extraction

Summary: the purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on postoperative pain.

background: third molar surgery is the most common procedure performed in oral and maxillofacial surgery practice. this procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact. traditionally, rotating instruments like burs have been used for osseous surgery. piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique. corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity. many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique, regarding postoperative pain and working time, or studies comparing the conventional method with or without dexamethasone injection. only one recent study (nov 2018), conducted by gümrükçü z. et al. has compared piezosurgery and dexamethasone injection in third molar surgery, but without evaluating the combined effect of these two techniques on postoperative pain. objectives: the objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery. methods: the study design is a randomized controlled clinical trial: 80 patients with mandibular third molar impaction, indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique, and with or without intramuscular dexamethasone injection. postoperative pain will be assessed using a visual analog scale (vas) on days 1, 3, and seven postoperatively. the differences in post-operative pain within and between study groups (4 groups) will be tested using repeated measures of analysis of variance (anova) or friedman tests. differences in working time among the three techniques will be assessed using a repeated measure of anova. all statistical tests will be two-sided, and the significant level will be set at 0.05. all the analysis will be conducted using the statistical package for social sciences (spss) software version 22.

Eligibility criteria:
inclusion criteria: * age from 15 to 30 years, * having mandibular impacted third molars, exclusion criteria: * heavy smokers (≥20 cigarettes), * uncontrolled systemic conditions, * infection of the surgery site, * psychological problems, * history of allergy to dexamethasone, amoxicillin, or acetaminophen.

Keywords: impacted mandibular third molar surgery. pain dexamethasone piezosurgery
assessment of pain monitoring with ani/nipe monitor program in pediatric cardiac surgery postoperative.

Conditions: Pain

Summary: the main objective is to assess correlation between ani/nipe values and external evaluation comfort b scale during painful medical cares and during said comfort medical cares in intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery with extracorporeal circulation.

ani/nipe monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. it uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia). developed in surgical units, the ani monitor has rarely been studied in pediatrics (only 2 publications, and only concerning peroperative measures). the nipe monitor has only been available since 2014. nevertheless, adult surveys and fundamental scientific publications on heart rate variations suggest that these monitors can evaluate pain on a continuous way. no study has been led in pediatric intensive care units. in our study, a continuous blinded monitoring will be set up as soon as patients' admittance for all eligible subjects. we will study, for children in cardiac post-surgery, ani/ nipe values and comfort b values during both painful and non-painful cares to determine correlation between those values. we will analyze a posteriori the ani/nipe values, through a standardized protocol, to recount the sequence of care and to determine discrepancies in drug consumption. data gathering will be made in the first 48h after admittance in pediatric intensive care units (picu). patients will not be followed after leaving picu.

Eligibility criteria:
inclusion criteria: * ventilated children admitted in picu postoperative of cardiac surgery with extracorporeal circulation, consent of the parental control, children benefiting from social security system exclusion criteria: * heart rhythm disorder, use of heart rhythm disorder treatments, use of active pacemaker, which make ani/nipe values impossible to interpret

Keywords: pain care pediatric and neonatal intensive care units
a multicentre investigation of 2 cycles rituximab compared with standard regimen in management of steroid-resistant/relapsed immune thrombocytopenia （itp）

Conditions: Immune Thrombocytopenia

Summary: the project was undertaking by qilu hospital, shandong university and other several well-known hospitals in china. in order to report the efficacy and safety of rituximab in different frequencies for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 refractory itp adult patients from medical centers in china. one part of the participants are randomly selected to receive rituximab (given intravenously at a dose of 375mg/m(2) weekly for 2 weeks, i.e. day 1, 8; the others are selected to receive standard rituximab treatment (given intravenously at a dose of 375 mg/m(2) weekly for 4 cycles, i.e. day 1, 8, 15, 22). platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study. in order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (itp).

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \<30×10\^9/l, and with bleeding manifestations. 4. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received second-line itp-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. 3. received high-dose steroids or ivig in the 3 weeks prior to the start of the study. 4. current hiv infection or hepatitis b virus or hepatitis c virus infections. 5. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 6. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 7. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 8. patients who are deemed unsuitable for the study by the investigator.

Keywords: immune thrombocytopenia rituximab efficacy safety
methylenetetrahydrofolate reductase deficiency in ischemic stroke

Conditions: Hyperhomocysteinemia, Thrombotic, Cbs-Related; Ischemic Stroke; Epilepsy

Summary: adult onset epileptic seizures is rare and often associated with metabolic disorders, drugs and intracranial pathologies such as ischemia, hemorrhage or space-occupying lesions. methylenetetrahydrofolate reductase (mthfr) deficiency is one of the reasons that cause epileptic seizures in adults and can be ignored. mthfr deficiency is an autosomal recessive disorder that results in hyperhomocysteinemia and causes a predisposition to venous and arterial thrombosis. the incidence of the polymorphism is around 40% in some countries. the aim of the retrospective study is to investigate the incidence of mthfr deficiency in patients with adult-onset epileptic seizures.

epileptic seizures that begin in adulthood seriously affect patients, their relatives and the society in which they live financially and psychologically. the etiology of epileptic seizures starting at adult age includes head trauma, central nervous system infections, intracranial lesions, cerebrovascular events, metabolic diseases and drugs. while the causes of childhood epileptic seizures are generally considered idiopathic, adult-onset epileptic seizures are almost always due to a pathological process. epileptic seizures in adults may be a symptom of ischemic stroke. mthfr deficiency is associated with raised homocysteine concentration in the body and increased risk of stroke (1). studies have demonstrated that hyperhomocysteinemia is an independent risk factor for stroke (2). mthfr is the key enzyme in remethylation of homocysteine to methionine. mthfr deficiency is an autosomal-recessive disease characterized by high homocysteine and low or normal methionine. mthfr deficiency can cause vascular thrombosis in adults at early age; increased osteoporosis in elderly people; deep vein thrombosis, abortus during pregnancy; and infertility in adult males. in children, it is associated with intrauterine growth retardation, congenital heart diseases, neural tube defects, chromosome anomalies and hematologic tumors. in any age group, it might cause convulsions, increased thrombosis risk with some anticonvulsants and with the use of nitrogen protoxide in surgeries, and neuromotor retardation (3). the aim of this retrospective study is to investigate the incidence of mthfr deficiency in patients presenting with adult-onset epileptic seizures and diagnosed as ischemic cerebrovascular disease as a result of diagnostic tests.

Eligibility criteria:
inclusion criteria: * the patients with adult-onset epileptic seizures and diagnosed ischemic stroke in 3 years period. exclusion criteria: * pediatric patients with epileptic seizures

Keywords: methylenetetrahydrofolate reductase (mthfr) deficiency ischemic stroke epileptic seizures adult patients
177lu-psma as a systemic adjuvant treatment in patients with high and very high risk prostate cancer

Conditions: Prostate Cancer

Summary: single-center, non-commercial phase 2 clinical trial to evaluate 177lu-psma as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

the intervention will consist of a single administration of 177lu-psma in the research arm. both the study and control groups will receive standard hormone therapy. the study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy participation time in the study: intervention phase - 1 day; observation phase - 5 years

Eligibility criteria:
inclusion criteria: * giving a written informed consent * histopathologically confirmed high or very high risk prostate cancer * completion of radical locoregional treatment * completion of locoregional treatment within 3 months before inclusion to the study * ecog performance status 0 to 2 * age over 18 years * within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests * castrate testosterone level (testosteron \< 50 ng/dl lub 1,7 nmol/l) * patients with adequate function of main organs: * bone marrow: * neutrophils \> 1500x10\^9/l; * thrombocytes \> 100,000x10\^9/l; * hemoglobin \> 9 g/dl * liver: * bilirubin \< 2xuln (upper limit of normal) in patients with gilbert's syndrome \< 5xuln; * aminotransferase \< 3xuln * kidneys: * egfr \> 50 ml/min * albumin \>2.5 mg/ml * for men of reproductive age: the need to use double barrier contraception exclusion criteria: * the presence of distant metastases confirmed by radiological examination * absence of approval to use effective contraception method * absence of patient's consent to participate in the study * urinary tract obstruction or/and hydronephrosis. * concurrent anticancer treatment.
efficacy of tailored cognitive-behavioral therapy for chronic back pain

Conditions: Back Pain

Summary: this clinical trial compares two psychological treatments for back pain.

the primary objective is to examine the incremental efficacy of a patient-centered and tailored self-management treatment approach, tailored cognitive-behavior therapy (tcbt), for persons with chronic musculoskeletal pain. tcbt will be compared with a standard cognitive- behavior therapy (scbt) condition. the hypothesis is that tcbt will be associated with improved outcomes following treatment. outcome will be assessed by multiple standardized measures of key domains of the chronic pain experience. secondary objectives are to examine the process of successful self-management treatment.

Eligibility criteria:
inclusion criteria: * chronic back pain for at least 6 months * treatment by medication or physical therapy exclusion criteria: * acute or life threatening physical illness * current alcohol or substance abuse or dependence * current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery

Keywords: chronic back pain cognitive-behavioral pain stages of change
safety tolerability and efficacy study of cabaletta to treat oculopharyngeal muscular dystrophy (opmd) patients

Conditions: Oculopharyngeal Muscular Dystrophy

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of intravenous cabaletta® in oculopharyngeal muscular dystrophy (opmd) patients.


Eligibility criteria:
inclusion criteria: * males and females * 18 - 80 years (inclusive) of age * clinically and genetically diagnosed as opmd * moderate dysphagia (abnormal drinking test at screening and on the first dosing day, before drug administration) * patients who provide written informed consent to participate in the study * body mass index (bmi) \<30 kg/m2 exclusion criteria: * diabetes mellitus type 1 or 2 * other major diseases, e.g.: renal failure (creatinine clearance \<60ml/min), liver failure and chronic liver diseases (e.g. hepatitis b or c) , hiv carriers, tuberculosis, sle, rheumatoid polyarthritis, sarcoidosis, collagenosis * uncontrolled heart disease , chf, * other neuromuscular diseases * other disorders associated with esophageal dysphagia: e.g. severe gastroesophageal reflux (gerd), esophageal stricture due to mechanical or chemical trauma, infection (e.g. esophageal moniliasis), drug-induced dysphagia (e.g. bisphosphonates), esophageal rings and webs, spastic motility disorders of the esophagus. * history of malignancy (except non-invasive skin malignancy) * history of neck irradiation * pregnant or currently lactating women * obesity (bmi≥ 30) and associated morbidity * prior pharyngeal myotomy * weight loss of more than 10% in the last 12 months. * known hypersensitivity to any ingredients in the injection * patient receiving anticoagulant treatment (e.g. warfarin)

Keywords: case control, safety, tolerability, efficacy.
magrolimab + azacitidine versus azacitidine + placebo in untreated participants with myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndromes

Summary: the primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (mds) by revised international prognostic scoring system (ipss-r) as measured by complete remission (cr) and overall survival (os).


Eligibility criteria:
key inclusion criteria: * participants with myelodysplastic syndrome (mds) defined according to world health organization classification, with revised international prognostic scoring system (ipss-r) prognostic risk category of intermediate, high, or very high risk. * adequate performance status and hematological, liver, and kidney function. key exclusion criteria: * immediate eligibility for allogenic stem cell transplant (sct), as determined by the investigator, with an available donor. * prior treatment with cluster of differentiation (cd) 47 or signal-regulatory protein alpha (sirpα)-targeting agents. * any prior antileukemic therapy for treatment of intermediate, high, very high risk mds per ipss-r. * second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year. * contraindications to azacitidine. * clinical suspicion of active central nervous system (cns) involvement by mds. * known active or chronic hepatitis b or c infection or human immunodeficiency virus in medical history . * active hepatitis b virus and/or active hepatitis c virus, and/or hiv following testing at screening. * pregnancy or active breastfeeding. note: other protocol defined inclusion/exclusion criteria may apply.