Kornimate/medical-research-clean huggingface dataset:
the role of interventional pulmonology, microbiota and immune response in the patient with lung cancer

Conditions: Lung Cancer

Summary: this study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.


Eligibility criteria:
inclusion criteria: * patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (ct) and rp-ebus scans * control group - patients without non-small cell lung cancer * written (signed) informed consent to participate in the study exclusion criteria: * severe hypoxemia (partial pressure of oxygen (po2)\ 50 mmhg), * bleeding disorders * the diffusing capacity for carbon monoxide (dlcoc)\< 35 %, * forced expiratory volume in one second (fev1) \< 800 ml or fev 1 \< 30 %, * peripheral lung tumor was not visualised by rp-ebus longer than 30 minutes * large vessels (more than 3 mm) near the tumor on the ct scan, * technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment, * excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.

Keywords: cryobiopsy lung cancer gut-lung microbiota immune system
effect of malnutrition on liver and spleen stiffness in children

Conditions: Malnutrition in Children; Liver Stiffness; Spleen Stiffness; Shear Wave Elastography

Summary: this prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.

this is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. the study will include two groups: children diagnosed with malnutrition according to who criteria, and age- and sex-matched healthy controls without any known chronic illness. all participants will undergo shear wave elastography (swe) to measure liver and spleen stiffness using standardized ultrasound protocols. measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants. the primary objective is to compare organ stiffness values between malnourished children and healthy controls. secondary analyses will explore correlations between severity of malnutrition and stiffness values. the study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.

Eligibility criteria:
inclusion criteria: * children aged 6 to 18 years. * diagnosis of malnutrition based on world health organization (who) criteria (for malnutrition group). * healthy children without any chronic illness (for control group). exclusion criteria: * children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions). * children who have previously undergone liver or spleen surgery. * children with inability to cooperate during elastography measurement.

Keywords: malnutrition liver stiffness spleen stiffness shear wave elastography children
lung clearance index to identify scleroderma patients at risk for ild

Conditions: Scleroderma

Summary: this national jewish health (njh) investigator initiated pilot study funded by the shah foundation will prospectively perform a non invasive lung function test called lung clearance index (lci) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ild than those with normal vales.50 subjects will be enrolled from the rheumatology practice at njh and followed with phone interviews or electronic medical record (emr) record review yearly times 5 to determine if they have subsequently developed evidence of ild or pulmonary artery hypertension.

50 scleroderma patients without evidence of lung disease who have been seen by an njh rheumatologist will be invited to participate. they will have their medical records reviewed to determine eligibility and then perform hand held spirometry and lci testing. this measures evidence of small airway airflow obstruction and requires normal breathing while first on room air followed by inhaling a gas mixture of 100% oxygen. the oxygen concentration in exhaled breathing and the number of breaths needed to return to room air concentration of oxygen will be analyzed by a computer. medical information from the emr will be recorded and placed in a secure database, redcap, for statistical analysis to determine if lci results or other clinical features are predictive of which scleroderma patients are most likely to subsequently develop evidence of interstitial lung disease (ild) based upon yearly phone call interviews and emr record reviews within 5 years of baseline testing.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of systemic sclerosis (ssc) by an njh rheumatologist * age 21-75 * no evidence of scleroderma related lung disease (ild) * able to comprehend and sign an institutional review board (irb) approved consent form. exclusion criteria: * patients without a rheumatologists confirming a diagnosis (dx) of ssc * patients with evidence of lung involvement based upon; thoracic imaging, abnormal pulmonary function tests (pfts); forced vital capacity( fvc), forced expiratory volume in 1 second (fev1) or a diffusion capacity for carbon monoxide (dlco) \< the lower limit of normal (lln) or saturation of oxygen in arterial blood (sao2) \< 90% . * cardiac echocardiogram or right heart catheter evidence of pulmonary arterial hypertension (pah). * \ 75 years of age * must not be pregnant or had eye surgery within 2 weeks of lci testing * must be able to comprehend and sign an irb approved consent form and complete lci testing
latent tuberculosis infection in renal transplant recipients

Conditions: Renal Transplant

Summary: the aim of this study is to estimate the usefulness of a t cell-based assay (i.e. t-spot.tb assay) for diagnosis of latent tuberculosis infection (ltbi) in renal transplant recipients. for this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

we evaluate the usefulness of a newly-developed t cell-based assay prior to undergoing immunosuppression in renal transplant recipients. among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. we will exam t-spot.tb test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. the results of t-spot.tb will be blinded to the investigators.

Eligibility criteria:
inclusion criteria: * age 16 or more * negative tuberculin skin test (induration less than 10 mm) exclusion criteria: * recent contact of patients with active pulmonary tuberculosis * suspected active tuberculosis

Keywords: tuberculosis transplantation
uark 2006-28 human cord blood transplantation in advanced hematological malignancies

Conditions: Multiple Myeloma

Summary: the researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.


Eligibility criteria:
inclusion criteria: * patients with advanced hematological malignancies who have failed at least two lines of therapy. * karnofsky performance score \> 60, unless due to disease and then \> 50. * age \> 18 years. * an expected survival of \> 3 months. * subjects must have signed an irb-approved consent and been informed about the investigational nature of the study. * cord blood must have negative serology for hiv. * release of cord blood. * the nucleated cell count of the cbu shall equal or exceed 1 x 107 per kg of recipient body weight. exclusion criteria: * liver function: total bilirubin \> 2x uln or ast/alt \> 3x uln. * creatinine \> 3.0 mg/dl.
efficacy and safety study of metronidazole, nystatin and dexamethasone combination therapy in bacterial and fungal vaginal infections

Conditions: Bacterial Vaginosis; Fungal Vaginal Infections

Summary: the purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.


Eligibility criteria:
inclusion criteria: * post-menarche women and premenopausal women, between 18 and 50 years old; * diagnosis of bacterial vaginosis (amsel criteria), fungal (positive koh test)or mixed vaginal infection; * patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days) exclusion criteria: * patients who have a known hypersensitivity to components of the formula ; * pregnant and lactating women ; * patients with other vaginal infections, such as infection by trichomonas vaginalis , c. trachomatis, neisseria gonorrhoeae , herpes or hpv. * knowledge of positive test result for human immunodeficiency virus ; * patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ; * patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ; * patients with other vaginal or vulvar conditions that may confound interpretation of clinical response; * patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ; * patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ; * known or suspected cancer ; * participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.
the role of immuknow® in the management of immunosuppressants in the renal transplant patient

Conditions: Kidney Transplant Immunosuppression

Summary: the purpose of this study is to demonstrate whether there are any outcome benefits of a serial immuknow assays in the management of de novo renal transplant recipients.

background: the management of renal transplant recipients is challenging in keeping a delicate balance of immunosuppression to avoid either infection (overimmunosuppression), or rejection (under-immunosuppression). conventional clinical parameters are not adequate enough. immuknow (cylex inc, columbia, md) is an fda-cleared assay for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. there have been limited retrospective studies discussing the effectiveness of the immuknow assay. there is no prospective head-to-head trial showing the benefits of periodic immuknow testing. objective: to demonstrate whether there are any outcome benefits of a serial immuknow assays in de novo renal transplant recipients patients and methods: a prospective, randomized, pilot, controlled 12-month study to compare the outcomes of 2 cohorts of de novo renal transplant patients will be conducted. the outcomes that will be investigated include a combined infection rate (primary end-point), separate infection rates and episodes, acute rejection rate and episodes, quality of life, graft and patient survivals (all secondary end-points). biopsy of the transplanted kidney is used to confirm rejection whenever possible. among the study cohort, the patients' immunosuppressants will be adjusted according to the results of a serial immuknow assay besides using conventional clinical parameters; whereas among the control cohort the patients' immunosuppressants will be adjusted according to conventional clinical parameters. expected results: at the end of this study we will be able to learn whether the study cohort patients have less infection, less acute rejection, better allograft function, better quality of life, and better graft or patient survivals.

Eligibility criteria:
inclusion criteria: 1. de novo kidney transplant patients who are eligible for kidney transplant according to unos criteria and agree to participate in the study. 2. patients of both sex aged between 18 to 80 years. exclusion criteria: * any patient with a known immunocompromised disease (e.g. patients with aids) or leukocytosis(\>15,000u/l)

Keywords: kidney transplantation immunosuppression immune monitoring
the use of exhaled nitric oxide in conjunction with the asthma control test to determine asthma control in pediatric patients

Conditions: Asthma

Summary: the purpose of this study is to determine if exhaled nitric oxide (eno) levels will be increased in pediatric patients with uncontrolled asthma as determined by the asthma control test (act). during the study the investigators will also examine if the combination of eno and act will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma by pediatric pulmonologist * age 6-18 years exclusion criteria: * age \ 18 years * history of bronchopulmonary dysplasia * history of cystic fibrosis * history of primary ciliary dyskinesia * current acute asthma exacerbation * current acute viral upper respiratory infection * recent ingestion of nitrate-rich foods
inpatient referral to comprehensive weight management for patients with obesity

Conditions: Obesity

Summary: hospitalized patients with obesity who are not already in cwm (comprehensive weight management), or not comfort care/hospice will be identified by the hospitalists then the study dietitian will consent for the patient for enrollment (and answer any question regarding diet/lifestyle) in the study. the intervention will be a cwm referral at discharge. the outcome will be what percentage of these patients go to the cwm clinic at 6 months. at 6 months, the investigators will also call each participant to get a qualitative idea of the process of inpatient referral and barriers to the cwm clinic visit. weight loss, starting on anti-obesity medication, bariatric surgery will be assessed as a secondary outcome.

* the investigators will conduct an uncontrolled, one arm interventional study on adult (≥ 18 years of age) hospitalized patients who have obesity (bmi ≥ 30 kg/m 2 or bmi ≥ 27 kg/m 2 if asian/south asian), and after stabilization of their acute medical conditions. prior to hospital discharge, patients will receive a referral for an outpatient comprehensive weight management clinic, with a message that will be sent to the cwm clinic scheduler. then the investigators will follow the patients forward for 6 months from hospital discharge to assess primary and secondary outcomes. also, the investigators will look at a historical control group of hospitalized patients with obesity (age, comorbidity matched) from 2014-2019 (chosen instead of 2020, to avoid any impact of 2020 covid 19 pandemic) and compare the primary and secondary outcomes. at six months after discharge, patients will receive a phone call from the investigators to ascertain whether they were able to go to the comprehensive weight management clinic and about their experience. * hospitalized patients who have decision-making capacity and whose acute medical condition has been stabilized who meet study criteria will be identified by study physician(s) who will look at his/her personal patient list on a regular basis to identify patients who meet enrollment criteria and will refer the patients to the co-investigator who is not directly involved in the patient's care who will then discuss enrollment with patients.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years of age) hospitalized patients who have obesity (bmi ≥ 30 kg/m2 or bmi ≥ 25 kg/m2 if asian/south asian) * who have decision-making capacity * whose acute medical condition has been stabilized. exclusion criteria: * patients in the icu or requiring \> 6 lpm of supplemental oxygen * patients enrolling in hospice/comfort care * patients who are already enrolled in weight management or have undergone previous metabolic / bariatric surgery. * non-english speaking patients. * pregnant patients
506u78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma

Conditions: Leukemia; Lymphoma

Summary: phase ii trial to study the effectiveness of 506u78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

objectives: i. determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed t-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506u78 on an alternate day schedule (days 1, 3, 5). ii. determine the safety and toxicity of 506u78 administered on this schedule to this patient population. outline: patients receive 506u78 iv over 2 hours on days 1, 3, and 5. if residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506u78. if day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. for day 22 or 29 marrow that is in complete response, patients receive 506u78 for two more courses on days 1, 3, and 5, administered every 21 days. patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.

Eligibility criteria:
disease characteristics: * histologically confirmed diagnosis of t-cell acute lymphoblastic leukemia (all) or lymphoblastic lymphoma (lbl) * leukemia or lymphoma cells should express at least two of the following cell surface antigens: cd1a, cd2, cd3 (surface or cytoplasmic), cd4, cd5, cd7, and cd8 * leukemia cells should be negative for myeloperoxidase or sudan black b if the only t cell markers present are cd4 and cd7, the leukemic cells should be demonstrated to lack the myeloid markers cd33 and/or cd13 * refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission * no cns leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy patient characteristics: * age: 16 and over * bilirubin no greater than 2 times upper limit of normal (unless due to leukemia) * creatinine clearance at least 50 ml/min (unless due to leukemia) * no neurologic toxicity of grade 3 or greater during prior treatment of all/lbl * no preexisting neuropathy of grade 2 or greater regardless of causality * no history of seizure disorder * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: * no concurrent erythropoietin * no other concurrent chemotherapy * no concurrent dexamethasone or other steroidal antiemetics * no concurrent hormone therapy, except for non-disease-related conditions

Keywords: recurrent childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma recurrent adult acute lymphoblastic leukemia t-cell childhood acute lymphoblastic leukemia t-cell adult acute lymphoblastic leukemia recurrent adult lymphoblastic lymphoma recurrent adult t-cell leukemia/lymphoma
analysing the effects of xingnaojing for mild-to-severe acute ischemic stroke

Conditions: Acute Stroke; Ischemic Stroke

Summary: the main purpose of this trial is to analyse the effects of xingnaojing for mild-to-severe acute ischemic stroke by metabonomics, proteomics and clinical parameters.

xingnaojing is widely used in china, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. the primary hypothesis of this trial is that , compared with the blank control group, xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . the serial changes may be the potential support to explain the intervention effect of xingnaojing. all participants will have a national institutes of health stroke scale(nihss)entry score of 4-25. participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. the primary outcome will be determined at 11 days.

Eligibility criteria:
inclusion criteria: * diagnosis of acute ischemic stroke； * symptom onset within 24 hours； * 35 ≤ age ≤ 80 years； * 4 ≤ nihss ≤ 25； * patient or legally authorized representative has signed informed consent. exclusion criteria: * expected length of hospital stay is less than 10 days; * planned or already receiving intravenous thrombolysis or endovascular treatment; * use of drugs with unknown composition within 1 week before enrollment; * patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group; * suspected secondary stroke caused by tumor, brain trauma, or hematological diseases; * already dependent in activities of daily living before the present acute stroke (defined as modified rankin scale score ≥ 2) ; * other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease); * other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis); * significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (alt), or aspartate aminotransferase (ast) value that is twice the upper limit of normal); * life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer) * other conditions that render outcomes or follow-up unlikely to be assessed; * known to be pregnant or breastfeeding; * currently receiving an investigational drug.
ultrasound guided diagnostic lumbar puncture in neurology

Conditions: Lumbar Puncture

Summary: subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. the primary objective of study is to compare the success rate of obtaining csf using ultrasound guided technique against the traditional landmark based approach. secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.

seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining csf. this study will be conducted in the neurology clinic. for subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. for subjects in the ultrasound group, site entry will be done using ultrasound guidance. success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.

Eligibility criteria:
inclusion criteria: * patient scheduled for lp through neurology's lp clinic * 18 years of age or older * able to understand the description of procedure and provide informed consent exclusion criteria: * any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. this includes subjects with spinal cord stimulators.