Kornimate/medical-research-clean huggingface dataset:
nasal inflammation following endotoxin challenge in patients with asthma

Conditions: Asthma; Eosinophilic; Asthma

Summary: a phase i clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from e. coli) in healthy controls and subjects diagnosed with asthma.

patients with severe asthma can be broadly classified into three endotypes (t2, t1, and t17) based on inflammatory cell and cytokine profiles. within these endotypes, many patients have high levels of neutrophils in the airways and mucosal epithelium. our preliminary data suggest that neutrophils in the airways and blood of patients with severe asthma are heterogenous and that subsets exist. the nature of these subsets appears to differ between t2, t1, and t17 asthma endotypes. in order to advance the field and determine the mechanisms that underpin severe neutrophilic asthma, investigators plan to longitudinally assess transcriptional profiles and functional properties of neutrophil subsets that migrate to the nasal cavity following exposure to a standardized dose of clinical reference center endotoxin (irb#hs-3131-528, ind 018580). investigators will recruit 15 subjects of each asthma endotype (45 total participants with asthma) and 15 healthy controls. lps will be used to elicit migration of neutrophils into the nasal cavities. neutrophils will be isolated from the nasal cavities using both nasal lavage and nasal brushes 20 minutes, 1 day and 3 days after endotoxin challenge. neutrophil biology will be assessed using single-cell rnaseq and ex vivo functional assays.

Eligibility criteria:
inclusion criteria: * participants will have asthma diagnosed by a health care provider. healthy controls are individuals without asthma. * written informed consent exclusion criteria: * current or recent illness (in the past 4 weeks) * recent asthma exacerbation (past 4 weeks) * history of nasal perforation or nasal surgery * nasal polyposis * presence or prior history of cardiac or systemic disease * bleeding disorder, use of systemic anticoagulants, or antiplatelet therapy * immunocompromised state (hiv, immunoglobulin deficiency, systemic immunosuppressants excluding corticosteroids) * use of tobacco or marijuana in the past 2 months or greater than a 10 pack-year smoking history * currently pregnant or breastfeeding
enhanced recovery after surgery in hirschsprung disease

Conditions: Hirschsprung Disease

Summary: the study is designed to determine if enhanced recovery after surgery (eras) principles could provide benefit for pediatric patients undergoing radical surgery for hirschsprung's disease (hd). half of patients will receive the eras program, while the other half will receive the traditional program.

optimized peri-operative care within an enhanced recovery after surgery (eras) protocol is designed to reduce morbidity after surgery, resulting in a shorter hospital stay. the present study evaluated this approach in the context of radical surgery for pediatric patients with hirschsprung's disease(hd). patients undergoing radical surgery for hd will be enrolled in a randomized clinical trial comparing eras protocol vs a control group that received standard care. the primary outcome is median length of postoperative hospital stay. the second outcomes include postoperative complications rates，gastrointestinal function recovery time，mean cost per patient，readmission rates within postoperative 30 days，and the levels of stress and inflammation marker.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hirschsprung disease exclusion criteria: * with other disease * receive emergency surgery * need to do the ostomy * full colonic hirschsprung disease

Keywords: enhanced recovery after surgery hirschsprung disease
the shield whole lung lavage study

Conditions: Silicosis

Summary: an observational cohort study that will assess the efficacy of whole lung lavage in workers with silicosis or silica-induced bronchitis.

background: silicosis is a fatal lung disease caused by inhaling silica particles. australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone. aims: to determine the effectiveness and safety of whole lung lavage (wll) in workers with silicosis due to significant engineered stone exposure. design: participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo wll as part of their normal care will be enrolled. they will undergo the following interventions pre and 3 months post wll, some of which would have been carried out as part of routine standard care: 1. complex pulmonary function tests (pfts) - standard care 2. hrct scan (if not within 6 months of wll) - standard care 3. blood tests 4. cardiopulmonary exercise testing 5. forced oscillatory technique 6. xv lung ventilation analysis 7. questionnaires (k-bild and lcq)

Eligibility criteria:
inclusion criteria: * males and females aged \>=18 years and scheduled for wll at the study site as part of routine clinical care * history of exposure to respirable crystalline silica (rcs) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining) * elimination of workplace exposure to rcs for a minimum of 6 months * ground glass nodularity \> extent of solid nodularity on hrct, as judged by investigator or evidence of silica-induced bronchitis * evidence of disease progression within the past 2 years, defined as any of * a relative decline in the fvc or fev1 of at least 5% of the predicted value, * worsening of respiratory symptoms * increased extent of silicosis on high-resolution ct scan * able to understand and sign a written informed consent form (or legally authorised representative) exclusion criteria: * ongoing workplace exposure to rcs or removal of workplace exposure of less than 6 months * progressive massive fibrosis, defined as areas of confluent fibrosis with diameter \> 10mm on hrct. * fev1 or fvc \< 50% predicted * dlco \<50% predicted * contraindication to wll, as judged by the investigator * actively or imminently listed for lung transplantation * females with a positive pregnancy test at screening or currently breastfeeding * any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months * any condition other than silicosis that, in the opinion of the investigator, is likely to result in the death of the participant within the next 24 months * significantly impaired cardiac function
biofeedback gait training on gait quality in stroke

Conditions: Stroke

Summary: post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. however, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.


Eligibility criteria:
inclusion criteria: * first stroke * stroke onset time ≥ 6 months * functional ambulation category ≥3 * passive range of motion of affected hip extension is at least 10 degrees * mini-mental state measurement score ≥ 24 points exclusion criteria: * modified ashworth scale of affected ankle plantar flexors ≥ 2 * muscle strength of affected ankle plantar flexors via manual muscle testing ≤ 1 * uncorrected auditory impairment * severe cardiovascular disease or uncontrolled hypertension * other orthopedic diseases that may affect walking ability * other neurological disease except stroke

Keywords: biofeedback gait symmetry gait variability gait training
micronized and ultramicronized palmitoylethanolamide in covid-19 patients

Conditions: Covid19

Summary: sars-cov-2 infection is a condition characterized by excessive leukocyte infiltration, massive release of chemokines, proteases and cytokines, the so-called "cytokine storm", which promote the inflammatory process and contribute to exacerbation of covid-19 symptomatology. because of the abnormal release of pro-inflammatory cytokines by non-neuronal cells of the immune system, such as the mast cells in periphery, and microglia at central level, the body activates a defensive neuroinflammatory process that, if not controlled, can become pathological. therefore it's important to intervene early on neuroinflammation, in order to limit the progression of the disease. a possible intervention is represented by palmitoylethanolamide (pea), an endogenous molecule of the n-acylethanolamine family synthesized "on demand" in response to "stress factors" to restore tissue homeostasis, able to control mast cells and microglia uncontrolled activation. experimental evidence in vitro and in vivo demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultra-micronized pea (mpea and umpea), confirmed in various clinical investigations conducted in patients with different pathological conditions. the aim of this study is to investigate the efficacy of a compound containing mpea + umpea on peripheral inflammatory markers, neuroinflammation, and others clinical parameters in intensive care patients with covid-19 interstitial pneumonia.


Eligibility criteria:
inclusion criteria: * intensive care unit hospitalization for interstitial pneumonia due to covid-19 diagnosis (nasal swab/sputum/bronchoalveolar lavage positive for sars-cov-2 infection) exclusion criteria: * pregnancy or breastfeeding; * known allergy or hypersensitivity to the product or its excipients; * inability to take the product per os or via nasogastric tube.
study of dasatinib and bendamustine in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (cll).


Eligibility criteria:
inclusion criteria (cohort #1): * diagnosis of b-cll by nci criteria * require chemotherapy and have fully recovered from previous administered chemotherapy * subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. failing at least one purine analogue regimen * subjects have received three or fewer prior treatment regimens * ecog status of 0 - 2 inclusion criteria (cohort #2): * if dose level + 3 is reached, the criteria is the same as outlined for cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive) exclusion criteria: * unwilling or unable to use an acceptable method to avoid pregnancy * uncontrolled or significant cardiovascular disease, including prolonged qtc interval * history of significant bleeding disorder, unrelated to cll * prior concurrent malignancy * drugs that generally accepted to have the risk of causing torsades de pointes * autoimmune hemolytic anemia requiring therapy or transfusion support * autoimmune thrombocytopenia requiring steroid therapy or transfusion support * richter's syndrome * transformation to prolymphocytic leukemia
study to compare once a day sevelamer dosing with three times per day sevelamer dosing

Conditions: Chronic Kidney Disease

Summary: a randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. following a two week run-in period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.


Eligibility criteria:
inclusion criteria: * life expectancy of at least 12 months, * patients have received hemodialysis three times per week for 3 months or longer, * patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l). exclusion criteria: * active bowel obstruction, * dysphagia, * swallowing disorders, * severe gastrointestinal motility disorders, * active ethanol or drug abuse (excluding tobacco), * need for antidysrhythmic or antiseizure medications used to control these conditions, * poorly controlled diabetes mellitus or hypertension, * active vasculitis, * active malignancy other than basal-cell carcinoma, * hiv infection, * any clinically significant unstable medical condition as judged by the investigator.
effect of a specific hand intervention in women with arthralgia secondary to hormone therapy following breast cancer.

Conditions: Arthralgia

Summary: this study aims to evaluate the impact of a 12-week hand exercise program on pain, manual dexterity, and hand function in women experiencing hand joint pain (arthralgia) due to hormone therapy after breast cancer. participants will be randomly assigned to either an intervention group, where they will perform specific hand exercises, or a control group, which will not receive any exercise program. pain levels, hand function, and manual dexterity will be assessed before and after the intervention using questionnaires and functional tests. the goal is to determine whether targeted hand exercises can improve pain and daily hand use in this population.

this is a randomized, evaluator-blinded clinical trial that aims to determine the effects of a 12-week hand exercise program on pain, manual dexterity, and functional performance in women experiencing hand arthralgia due to hormone therapy following breast cancer. participants will be randomly assigned to one of two groups: an intervention group performing specific hand exercises or a control group with no exercise intervention. the primary outcome will be changes in hand pain levels assessed using the brief pain inventory (bpi) and mccaffrey's initial pain assessment tool. secondary outcomes will include functional performance measured with the dash and abilhand questionnaires, as well as manual dexterity, speed, and coordination assessed through standardized tests (purdue pegboard test, box and block test, and minnesota rate of manipulation test). the study will evaluate the potential benefits of targeted hand exercises for improving pain, dexterity, and quality of life in breast cancer survivors experiencing treatment-related hand symptoms. detailed description study design: type: interventional (clinical trial) allocation: randomized intervention model: parallel assignment masking: single-blind (evaluator) primary purpose: treatment duration: 12 weeks

Eligibility criteria:
inclusion criteria experiencing hand arthralgia as a result of hormone therapy (aromatase inhibitors or tamoxifen) following breast cancer. ability to communicate pain levels effectively. ability to follow simple instructions to participate in the intervention and assessments. exclusion criteria participants requiring any medication changes during the study period that could influence pain levels (increase or decrease). concurrent physiotherapy or occupational therapy specifically targeting the hand during the study. pre-existing diagnosis of arthritis or osteoarthritis in the hand before starting hormone therapy. presence of systemic diseases associated with hand arthralgia. neurological conditions affecting hand movement.
12 weeks adjuvant docetaxel plus trastuzumab in patients with small, node-negative, her2-positive breast cancer (sober)

Conditions: Breast Cancer

Summary: this phase ii trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, her2-positive breast cancer.

many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of her2 positive early breast cancer with tumor size ≥1cm or node metastasis.but in pt1n0m0 breast cancer patients, patients with her2 positive tumor show worse prognosis than those with her2 negative tumor.a short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, her2-positive breast cancer.

Eligibility criteria:
inclusion criteria: women aged ≥18 years have finished radical operation pathologically confirmed dignosis of infiltrating primary breast cancer according to ajcc ,pt≤1cm, pn0,no evidence for metastasis operation specimens are available for er, progesterone receptor (pr) and her2 detection, patients should be her2 positive tumor (3+ by ihc or fish+ ) has eastern cooperative oncology group (ecog) performance score 0-1,expected survival time \> 12 months adequate bone marrow function,adequate liver and renal function,and adequate coagulation function. women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study. written informed consent according to the local ethics committee requirements. exclusion criteria: pt\>1cm or node positive metastatic breast cancer any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days with a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease has symptomatic peripheral neuropathy \> grade 2 according to nci known severe allergy to any drugs in this study has cadiac dysfunction or lung dysfunction defined as follows: 1. grade ≥3 chf according to nci ctcae v 4.0 or nyha≥ii 2. angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms 3. uncontrolled high-risk arryhthmia 4. unconrolled hypertension has active hepatitis b or hepatitis c with abnormal liver function tests (lfts) or is known to be hiv positive patient is pregnant or breast feeding -

Keywords: trastuzumab adjuvant therapy
a study to evaluate change in viral load after opn-019 in adults with covid-19

Conditions: Covid19

Summary: the purpose of this study is to determine both the magnitude and duration of viral load (copies/ml) reduction after a single dose of opn-019. the variability associated with viral counts will be utilized to inform the study design of future studies.

a randomized, single dose, adaptive design, proof of concept study in subjects who have tested positive for sars-cov-2 infection, are recently infected, and who have mild or no symptoms. patients will be required to have a score ≤ 2 on the who ordinal scale for clinical improvement (covid-19 therapeutic trial synopsis; feb 18, 2020). those meeting the inclusion criteria will be randomized to 1 of 2 arms: opn-019 (2 sprays per nostril) or soc. once randomized, subjects will have baseline nasal and oropharyngeal swabs performed for qrt-pcr viral load and infectious viral particle assessment. the subject will then be administered the study medication. subsequent nasal and oropharyngeal swabs will be taken at 1 hour, 3 hours, 6 hours, 8 hours, 12 hours, and 24 hours. cohorts of 10 subjects will be randomized into the study and the results from those subjects will be evaluated to determine if changes in the inclusion criteria or study assessments are required.

Eligibility criteria:
inclusion criteria: 1. men or women aged 18 years and older at visit 1 (baseline/screening) 2. women of child-bearing potential must have a negative urine pregnancy test at visit 1 (baseline/screening) 3. must be confirmed positive for sars-cov-2 with rt-pcr testing of a nasal swab taken within 72 hours prior to randomization (first dose of study drug) 4. must have a score ≤ 2 on the who ordinal scale for clinical improvement 5. subject must be willing to refrain from any other intranasal instillations (e.g., medications, saline, etc.) for 24 hours after study medication dosing 6. must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. exclusion criteria: 1. women who are pregnant or lactating 2. hospitalized subjects or subjects requiring nursing care for covid-19 3. currently has one of the clinical signs suggestive of moderate-to-severe covid-19 illness: 1. o2 saturation of ≤ 93% on room air at sea level 2. heart rate ≥ 90 beats per minute (after seated for 5 min) 3. respiratory rate ≥ 20 breaths per minute 4. receiving respiratory support (including any form of oxygen therapy) 5. history of hypothyroidism, goiter, hyperthyroidism, thyroid tumor, autoimmune thyroid disease 6. currently taking medications that contain iodine or currently taking lithium 7. receiving any other investigational drug 8. has an allergy, hypersensitivity, or contraindication to povidone iodine 9. has an allergy or hypersensitivity to any excipients in study medication 10. any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study