Kornimate/medical-research-clean huggingface dataset:
evaluate the efficacy and safety of n02rs1 in patient with acute bronchitis

Conditions: Acute Bronchitis

Summary: a multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of n02rs1 in patients with acute bronchitis

suitable subjects randomized to the experimental or control group. the subjects eat ip during 7days. visit 3(3 days) evaluate bss through phone call and visit 4(8 days) evaluate efficacy and safety.

Eligibility criteria:
inclusion criteria: * patients over 19, under 75 of age * patients acute bronchitis, sputum symptoms, bss over 7 points. * patients acute bronchitis within 7days. * non-pregnant, patients who agree to contraception. * patients who can write diary and available to communicate. * patients voluntarily agreed exclusion criteria: * patients with hypersensitivity to the drug. * patients who have gotten systemic steroid treatment within 4 weeks. * patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days. * patients who have gotten treatment of mucus solvents or antitussives within 3 days. * patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease. * patients heart disease, severe kidney, liver disease. * the bleeding tendency or immunosuppressed patients. * patients with clinically significant abnormal values. * pregnant women or nursing mothers. * patients alcoholics or drug abuse. * patients taking other clinical trail's medicines within 30 days.
surgeon infiltration ql block comparison

Conditions: Quadratus Lumborum Block; Surgical Wound Infiltration

Summary: the purpose of this study is to learn if using a quadratus lumborum (ql) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. the ql block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. this block will not affect movement in the leg and/or make the legs weak. some institutions, including duke, use the ql block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility criteria:
inclusion criteria: * english speaking * asa 1-2 patients undergoing living donor nephrectomy exclusion criteria: * asa 3 or 5 * diagnosis of chronic pain * daily chronic opioid use (over 3 months of continuous opioid use) * inability to communicate pain scores or need for analgesia * infection at the site of block placement * pregnant women (as determined by standard of care day-of surgery urine bhcg) * intolerance/allergy to local anesthetics * weight \<50 kg * suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years * uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance * current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Keywords: bupivacaine living donor nephrectomy
undiagnosed copd and asthma population study (ucap)

Conditions: Asthma; COPD

Summary: previous population health studies suggest that up to 10% of canadian adults have undiagnosed asthma or copd- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. our study will use targeted casefinding to find people with undiagnosed asthma and copd in canadian communities. the investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. the investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.


Eligibility criteria:
inclusion criteria: * subjects at least 18 years old; * subjects who score \> or = to 6 points on the asthma screening questionnaire or \> 19.5 points on the copd diagnostic questionnaire; * subjects who have given written informed consent to participate in this trial in accordance with local regulations; * subjects able to perform pre and post bronchodilator spirometry to measure lung function; additional inclusion criteria for rct: those subjects who have undiagnosed airflow obstruction (i.e. asthma will be diagnosed in subjects with airflow obstruction whose fev1 improves by \> 12% and 200 ml after bronchodilator and copd will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the rct. exclusion criteria: * subjects who report a previous physician diagnosis of asthma. * subjects who report a previous physician diagnosis of copd * subjects with any of the following conditions within the past 3 months: heart attack or hospitalization for other heart problems; stroke; aortic or cerebral aneurysm; detached retina or eye surgery * subjects who are in the third trimester of pregnancy * subjects involved in another interventional trial
blood biomarkers as predictors of covid-19 disease progression in recently infected chronic haemodialysis patients

Conditions: COVID-19 by SARS-CoV-2 Infection

Summary: sars-cov-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (il-6). the apparently strong association between blood levels of inflammaory cytokines and sars-cov-2 disease severity has led clinicians to evaluate the administration of steroids or anti-il-6 antagonists in severely ill patients. as of this day, biomarkers capable of predicting clinical disease progression in covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis the investigators formulate and intend to test is that innate il-6 responsiveness varies between recently infected covid-19 patients and could predict disease outcome. to test this hypothesis, the investigators propose to follow recently infected chronic haemodialysis patients with moderate covid-19 symptoms. these patients stand a higher risk to progress to severe disease. the investigators plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. after incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for il-6 content. associations between il-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 covid-19 chronic haemodialysis patients with moderate symptoms followed in 9 centers.


Eligibility criteria:
inclusion criteria: * patients with end-stage chronic renal disease requiring haemodialysis support; * sars-cov-2 positive (rt-pcr); * covid-19 symptoms at least once over a 8-day period preceding inclusion; * hospitalized or outpatients in one of the study centers: chu de nice, chu de strasbourg, hôpital necker (aphp), hôpital kremlin bicêtre (aphp), hôpital pitié-salpétriêre (aphp), hospices civils de lyon, chu de saint-etienne, chu de montpellier, hôpital la conception (aphm); * age \> 18 years; * free and informed consent. exclusion criteria: * age \> 85 years ; * peritoneal dialysis; * onset of symptoms (fever and/or cough) for more than 8 days; * acute respiraytory distress despite oxygen therapy, 02 ≥ 4l/min, arterial pressure \< 85/55 mmhg or hemodynamic instability at time of inclusion, encephalopathy with glasgow coma scale \< 14; * treatment with non-steroids anti-inflammatory agents within the laste 14 days preceding onset of symptoms; * active bacterial or fungal infection documented at inclusion; * pregnancy; * under guardianship or curatorship; * non-affiliated person with social security.
safety, tolerability, and pharmacokinetics of inhaled virazole administered via air-jet nebulizer in healthy volunteers

Conditions: Healthy

Summary: this study is a phase 1a, randomized, double-blind, placebo-controlled, safety, tolerability, and pk study in healthy adult volunteers. participants were screened for eligibility within 14 days prior to enrollment. four successive cohorts were enrolled, with each cohort receiving a single dose of virazole or placebo using different delivery regimens.


Eligibility criteria:
inclusion criteria: 1. subject is a male or female ≥ 18 and ≤65 years of age. 2. for a female, must be of non-childbearing potential according to 1 of the following criteria at least 6 months prior to screening: * hysteroscopic sterilization; * bilateral tubal ligation or bilateral salpingectomy; * post-menopausal with spontaneous amenorrhea for ≥ 12 consecutive months with follicle-stimulating hormone \[fsh\] \> 25.8 miu/ml; or * having had bilateral oophorectomy (with or without hysterectomy). 3. for a male subject must be vasectomized with confirmed postvasectomy semen analysis or a male subject with a documented diagnostic of infertility. 4. subject willing and able to provide written informed consent. 5. subject has a body mass index (bmi) ≥ 18.50 and \< 30.00 kg/m2. 6. subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator. 7. subject has suitable venous access for blood sampling exclusion criteria: 1. subject has a history of hypersensitivity to ribavirin. 2. subject has a history of asthma, copd, or bronchospasm. 3. subject has anemia defined as hemoglobin or rbc \<75% of the institutional lower limit of normal for age and gender. 4. subject has any major illness or systemic infection (including covid-19) within 4 weeks of the screening visit or has a clinically relevant history or is currently suffering from a disease or condition that, in the opinion of the investigator, may affect the evaluation of the study drug or place the subjects at undue risk. 5. subject is seropositive for human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis b virus (hbv), or positive for sars-cov-2 at screening. 6. subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s). 7. subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the baseline visit. 8. subject has donated 500 ml or more of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days prior to the baseline visit. 9. subject is currently participating in any drug or device clinical investigation or has received an investigational agent or approved drug that, in the investigator's judgement, may have a chemical or pharmacological interaction with virazole if administered within 5 half-lives or 30 days of the baseline visit. 10. subject has any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
pulmonary embolism diagnosis: ultrasound wells score vs traditional wells score

Conditions: Pulmonary Embolism

Summary: pulmonary embolism (pe) should be suspected in patients with dyspnea, chest pain, syncope, shock/hypotension, or cardiac arrest. discriminating patients in different categories of pre-test probability of pe has become a key step in all diagnostic algorithms for pe. the most frequently used clinical prediction rule is the wells score ("pe likely" \> 4 points and "pe unlikely" ≤ 4 points). pe can be safely ruled out in patients with a "pe unlikely" associated with a negative d-dimer test result. conversely, patients with "pe likely" or positive d-dimer level should undergo further diagnostic testing, like multidetector computed tomography pulmonary angiography (mctpa). wells score accuracy is not optimal. vein and lung us can be rapidly performed at bedside as an extension of physical examination and have a high specificity. the aim of this study is to evaluate if the combination of clinical data reported in the wells score and us data obtained from vein and lung us (us wells score) has a better diagnostic accuracy compared to traditional wells score. in adult patients suspected of pe traditional wells score will be calculated and vein and lung us (multiorgan us) will be performed in all patients and and us wells score calculated. the us wells score differs from the traditional wells score in the following items: "signs and symptoms of dvt", replaced by "vein us showing dvt", and "alternative diagnosis less likely than pe" replaced by "alternative diagnosis less likely than pe after multiorgan us". this latter item is considered positive if at least one subpleural infarct is detected at lung us, and negative if no subpleural infarcts are detected and an alternative diagnosis like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of presentation. if no findings are detected at lung us, the points for the item remain the same assigned by traditional wells score. final diagnosis of pe will be preferentially established by mctpa and in patients discharged without a second level imaging test because of negative wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter the 3 months follow-up protocol. the diagnostic performance of traditional and us wells scores will be assessed by calculating sensitivity, specificity, positive, and negative predictive value, and likelihood ratios. failure rate and efficacy of d-dimer in patients stratified as "pe likely" and "pe unlikely" will also be calculated.


Eligibility criteria:
inclusion criteria: * patients more than 18 years old * patients presenting with dyspnea, thoracic pain or syncope, palpitations, cardiac arrest * suspicion of pe exclusion criteria: * patient did not consent to participate in the study * presence of a diagnosis alternative to pe objectively demonstrated after the first assessment.

Keywords: pulmonary embolism diagnosis emergency medicine ultrasonography
ndt effectiveness study

Conditions: Cerebral Palsy; Neuromuscular Diseases; Neurodevelopment Treatment

Summary: the purpose of this study is to determine whether there is a functional change in children with cerebral palsy (cp) and other neuromuscular disorders participating in neurodevelopmental treatment (ndt) intervention using the contemporary practice model (cpm).


Eligibility criteria:
inclusion criteria: * the children will be aged 2 to 15 years with a diagnosis of cp, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified. * children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request. * children and their families are available and willing to attend the practicum portion of the course for both blocks. exclusion criteria: * parent/guardian unable to complete the 4 required interview sessions. * unable to commit to attending 75% of practicum sessions.
utilization of imri for transsphenoidal resection of pituitary macroadenomas

Conditions: Pituitary Macroadenoma

Summary: the investigators are studying the utility of intra-operative magnetic resonance imaging (imri) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative mri after resection, or no intra-operative mri. the investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.


Eligibility criteria:
inclusion criteria: * adults 18-90 * capable of giving informed consent * elect for transsphenoidal surgery * has pre-operative mri demonstrating pituitary tumor that is: 1. deemed resectable using a transsphenoidal approach and 2. has a maximal diameter equal to or greater than 15 mm. * no contraindications for mri. exclusion criteria: * children (age \< 18) * not able to give consent * no pituitary tumor visible on mri or an adenoma measuring less than 15mm in maximal dimension. * unable to tolerate mri
effectiveness of a nutritional consultation and exercise program in esophageal cancer patient

Conditions: Esophageal Cancer

Summary: in this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. the purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. these treatments frequently cause or exacerbate poor nutritional status. recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. the aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated * informed consent signed exclusion criteria: * stage iv, underwent palliative chemotherapy or radiotherapy patient * clinically significant cardiac or pulmonary disease * unable to walk or exercise
the effect of proactive clinical ethics consultations on end-of-life care of the critically ill in the intensive care settings

Conditions: Proactive Clinical Ethics Consultation; the Critically Ill

Summary: study objective: this study is planning to explore factors predicting the use of life-sustaining treatment, develop the screening criteria of proactive clinical ethics consultations, the effect of proactive clinical ethics consultations and interprofessional practice on end-of-life care of the critically ill in the intensive care settings, and develop the competency for trainees by interprofessional education. methods: data will be collected prospectively. data between january 2013 and april 2014 was collected from hospital electronic record and ethics consultation document. all data will be analyzed for patients dying in the intensive care settings during the first stage of the study. factors predicting the use of life-sustaining treatment will be determined. the delphi technique will be applied to secure a consensus among the panel of experts chosen to help develop the screening criteria of proactive ethics consultations. a prospective randomized controlled trial will be conducted during the second stage of the study on a convenience sample of adult critical ill patients in the intensive care settings. patients will randomize to the intervention group receive proactive ethics consultations. the control group will undergo routine intensive care, receiving clinical ethics consultations as requested by healthcare team, patients or family. all participants will be asked to complete a questionnaire rating their satisfaction with the healthcare process and consultations if conducted. mean length of stay and the duration of the use of life-sustaining treatment will be compared between two groups. secondary outcomes will include the proportion of satisfied families and healthcare team members. the interprofessional education with the core curriculum and case scenario for simulation will be developed, implement, and evaluated.


Eligibility criteria:
inclusion criteria: 1. medical staff involved in caring for terminal patients 2. cases of active clinical ethics consultation in our hospital exclusion criteria: 1. medical staff who refuse to participate in the study or are unable to understand the way the study is conducted 2. cases of refusing to participate in the research or unable to understand the way the research is conducted.

Keywords: proactive clinical ethics consultation critically ill end-of-life care interprofessional practicethe interprofessional education
study in patients with asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.


Eligibility criteria:
inclusion criteria: * children with a history of asthma * written guardian approval exclusion criteria: * current or recent asthma exacerbation, requiring hospitalization * history of smoking * debilitating or systemic and/or life-threatening diseases.

Keywords: asthma formoterol fumarate
self-sampling for human papillomavirus (hpv) testing in african american women - mississippi delta

Conditions: Cervical Cancer

Summary: the purpose of this study is to examine the efficacy and costs of this patient-centered approach ("choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in mississippi (pap test at the local department -"pap") among un/under-screened african american women in the mississippi delta using a theory-based, culturally relevant intervention implemented by peer health educators (phes).

objective: our objective is to examine the efficacy and costs of a patient-centered approach ("choice" between self-sampling and pap test) in adherence to cervical cancer screening as compared to pap test at the local health department ("pap") among un/under-screened african american women in the mississippi delta. hypotheses: women in the "choice" arm will have a higher cervical cancer screening adherence as well as higher satisfaction than women assigned to the "pap" arm; (2) within the "choice" arm, more women will choose and complete self-sampling than pap test; and (3) the "choice" intervention will be on average less costly and more cost-effective than the "pap" intervention. specific aims: (1) to compare the impact of these two intervention approaches, "choice" versus "pap", on cervical cancer screening adherence through a group randomized controlled trial; (2) to compare patient satisfaction between the two intervention approaches; and (3) to compare the costs and cost-effectiveness of these two intervention approaches, "choice" versus "pap". study design: 12 towns will be randomized to either "choice" or "pap" (180 women/arm). peer health educators (phes) will identify african american women who report not having undergone cervical cancer screening in the past three years and deliver a brief theory-based, cultural relevant educational session on cervical cancer and screening using a door-to-door approach. women randomized to the "pap" arm will be provided with information on how to schedule an appointment at the local health department. women randomized to the "choice" arm will be given the choice of attending the health department for a pap test or self-collecting their own sample at home to be sent for hpv testing. phes will follow-up with women in either arm who have a positive test in order to assure diagnostic evaluation and care.

Eligibility criteria:
inclusion criteria: * no personal history of cervical cancer * not have engaged in cervical cancer screening in the past four years exclusion criteria: * none

Keywords: self-sampling for hpv testing