Kornimate/medical-research-clean huggingface dataset:
rheumatoid purpura in children: a multicenter observational study of pediatric emergency department management and follow-up by primary care physicians

Conditions: Rheumatoid Purpura

Summary: the main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.

secondary objectives the secondary objective is to assess general practitioners current knowledge and practice of the condition and potential barriers to monitoring and follow-up by general practitioners. conduct of research children diagnosed with rheumatoid purpura within the past 2 years at the 3 participating sites will be included in the study if parental authority holders do not object. patients will be identified through the medical information department of each hospital. parents will be contacted - first by mail, then by phone - to request permission to collect the child's medical data from medical records, and to retrieve information on the surveillance and follow-up of the disease by general practitioners up to two years after diagnosis.

Eligibility criteria:
inclusion criteria: * underaged patient diagnosed with rheumatoid purpura during a visit to the pediatric emergencies of mulhouse, colmar and strasbourg * no objection to the study from the two holders of parental authority exclusion criteria: - patient followed in the context of a genetic or malformative pathology, an immune deficiency, or a cancer
phase ii study of capecitabine and weekly docetaxel followed by capecitabine maintenance for patients with metastatic breast carcinoma

Conditions: Metastatic Breast Cancer

Summary: in this phase ii study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.


Eligibility criteria:
inclusion criteria: * must have metastatic breast cancer * must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma * must have measurable or evaluable disease * ecog of 0-1 * patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer * must have adequate organ function * must be at least 19 years of age * peripheral neuropathy less than or equal to grade 1 * must have voluntarily signed informed consent * patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled exclusion criteria: * patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years * patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion * known uncontrolled existing coagulopathy * patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil * use of other investigational agents in the last 28 days * pregnant or lactating women * patients who are known hiv positive * patients with life expectancy of less than 3 months * sexually active patients unwilling to practice reliable contraception during the study
peak plasmablade tna versus traditional electrosurgery in subcapsular tonsillectomy

Conditions: Tonsillitis

Summary: the objective of this clinical study is to evaluate the operative performance of the peak plasmablade® tna during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the standard of care (soc).

tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess. the peak plasmablade uses pulsed radiofrequency (rf) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. the plasmablade has received fda clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ent) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. it is hypothesized that this benefit may improve the post-operative outcome of patients undergoing tonsillectomy. two study sites were granted approval for this prospective randomized study. potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. following enrollment, subjects were prospectively randomized to the soc or plasmablade (pb or peak) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (tna).

Eligibility criteria:
inclusion criteria: 1. children \& adolescents: age 3-17; adults: 18 and older 2. physically healthy, stable weight 3. requiring tonsillectomy and adenoidectomy per widely accepted indications 4. for adults, subject must understand the nature of the procedure and provide written informed consent. 5. for children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. in addition, parent or guardian must provide written informed consent. 6. for children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent. 7. subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets. exclusion criteria: 1. children: age 2 and under 2. bleeding disorder 3. peritonsillar abscess 4. requiring concomitant uvulopalatopharyngoplasty (uppp) 5. anticoagulation therapy which cannot be discontinued 6. unable to follow instructions or complete follow-up 7. currently taking any medication known to affect healing 8. currently enrolled in another investigational device or drug trial

Keywords: tonsillectomy plasmablade electrosurgery peak surgical medtronic advanced energy medtronic
a study to evaluate first-line ipilimumab + nivolumab in patients with locally advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (nsclc) in italy


Eligibility criteria:
inclusion criteria: * diagnosis of stage iv or recurrent nsclc (histologically or cytologically confirmed stage), without known egfr- or alk-alterations * decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of nsclc according to the italy label has been made independently of the study * patient is at least 18 years of age at time of treatment decision * patient provided written informed consent to participate in the study exclusion criteria: * current primary diagnosis of a cancer other than nsclc that requires systemic or other treatment * patients with known egfr- or alk-alterations * previous treatment with nivolumab and/or ipilimumab * patient already included in an interventional clinical trial for their advanced or recurrent nsclc (but: patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for os, can be enrolled)

Keywords: non-small cell lung cancer (nsclc)
once daily accelerated fractionation with concomitant boost to the gross tumor volume compared with twice daily hyperfractionation in concurrent chemoradiation in patients with limited disease small cell lung cancer

Conditions: Limited Disease Small Cell Lung Cancer

Summary: non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed sclc * limited stage (clinical stage i-iiib, lesion limited to one side of thorax, e.g. excluding t4 disease with malignant pleural effusion or n3 disease with contralateral hilum/supraclavicular lymph node invasion). * measurable or assessable lesion * age over 18 years old * performance status (ecog scale): 0\~2 * adequate organ functions: anc ≥ 1500/ul, plt ≥ 100 x 103/u, total bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl * inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist) * sexually active fertile men and women using a contraceptive method * patients should sign a written informed consest before study entry exclusion criteria: * t4 disease with malignant pleural effusion; n3 disease with contralateral hilum/supraclavicular lymph node invasion * lesion with mixed small cell nonsmall cell feature (pathologically) * prior chemotherapy or radiation therapy. * pericardial or pleural effusion on chest x-ray image regardless of cytological finding * t4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; concerns about possible perforation by tumor necrosis * severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with fev1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung * with atelectasis that makes gtv unidentifiable * other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence) * uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease

Keywords: concurrent chemoradiation in patients with limited disease small cell lung cancer
efficacy and safety of everolimus in combination therapy, in patients with her2-overexpressing metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: phase i: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with her-2 overexpressing metastatic breast cancer. phase ii: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with her-2 overexpressing metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female or male patients ≥ 18 years old with who performance status ≤ 1 * her-2 over-expressing metastatic breast cancer cells confirmed by histology * progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l) * patient resistance to trastuzumab and taxanes (phase ll) * measurable disease according to recist (phase ll) * patients neurologically stable with adequate bone marrow, liver and renal function exclusion criteria: * patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start * patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start * patients who have previously received mtor inhibitors other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer cancer of the breast human mammary carcinoma her-2 metastatic everolimus trastuzumab paclitaxel
prospective system analysis of the seasonal influenza virus transmissions and evolution in the city of basel basel

Conditions: Influenza

Summary: the project aims to use epidemiological tools to understand the transmission and evolution of influenza viruses at an individual and population level within a small-scale city (basel) through a combination of experimental, clinical, and mathematical advances. investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.

samples will be collected such as whole blood, serum and dna, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (pcr) and to determine colonization rates with staphylococcus aureus and streptococcus pneumonia. all samples except the first naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in batches. each influenza virus isolate will be sequenced using a "whole genome sequencing" approach. the viral transmission and evolution will be analysed using whole genome data for a detailed molecular and phylogenetic tree analysis, respectively. the epidemiological and geographical data will be incorporated into the phylogenetic model.

Eligibility criteria:
inclusion criteria: * each pediatric or adult patient, which fulfill the world health organization (who) definition of influenza like illness. * the case definition includes an acute respiratory infection with coughing, fever ≥38°c, and start of symptoms within the last 10 days. * presentation of the patient with influenza-like illness on the emergency ward of the university hospital basel or the university children hospital of both basel or a collaborating private practise. exclusion criteria: - case definition for influenza like illness is not fulfilled
bisoprolol in patients with heart failure and chronic obstructive pulmonary disease

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: the principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.


Eligibility criteria:
inclusion criteria: * symptomatic nyha ii or iii chronic heart failure * left ventricular systolic dysfunction * moderate or severe chronic obstructive pulmonary disease * with or without significant reversibility exclusion criteria: * beta-blocker contraindications * non-dihydropyridine (diltiazem / verapamil) calcium channel blockers * recent coronary percutaneous intervention or coronary artery bypass graft surgery * haemodynamically significant valvular disease or hypertrophic cardiomyopathy. * active myocarditis or pericarditis. * recent cerebrovascular accident or transient ischaemic attack * serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy * pregnancy, childbearing potential with inadequate contraception, breast feeding

Keywords: heart failure chronic obstructive pulmonary disease beta-blockers pulmonary function
us-guided trocar versus seldiger technique for percutaneous cholecystostomy

Conditions: Cholecystitis

Summary: a single-center randomized comparison of bedside ultrasound (us)-guided trocar technique versus the us-guided seldinger technique for percutaneous cholecystostomy

this is a single-center, randomized, controlled trial (rct), comparing bedside us-guided trocar technique versus the us-guided seldinger technique for percutaneous cholecystostomy (pc). the study will randomize a total of 100 consecutive patients (50 in each group) undergoing pc at one large tertiary university hospital. the primary endpoints will be technical success and procedure-related complication rates. secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.

Eligibility criteria:
inclusion criteria: * all patients requiring pc, regardless of the underlying cause. * signed informed consent form exclusion criteria: * age \ 100 years * the necessity for ct-guided pc catheter placement, according to the judgment of the performing physician * severe uncontrollable coagulopathy

Keywords: percutaneous cholecystostomy ultrasound-guided interventional radiology trocar seldinger
intraoral versus extraoral manual therapy in subjects with temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.


Eligibility criteria:
inclusion criteria: * unilateral temporomandibular pain for more than one month. * older than eighteen. * no previous treatment to temporomandibular pain in the last 3 months. * diagnosed based on the diagnostic criteria for temporomandibular disorders (dc/tmd). exclusion criteria: * patients with cervical or cranial trauma or whiplash. * diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia. * diagnosed of any vascular or metabolic disease. * previous cervical or temporomandibular surgery. * dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
the effect of monocyte values accompanied by lymphopenia on the prognosis of patients diagnosed with covid-19

Conditions: COVID 19; Lymphopenia Due to COVID-19; Monocyte

Summary: recent studies have shown that lymphopenia with cytokine storm syndrome is frequently found in covid-19 patients. these features may suggest that the modified immune system plays a key role in determining disease progression. lymphopenia or lymphocytopenia is a condition in which the number of lymphocytes in the blood is low. although t cells can be increased at the onset of covid-19, these patients tend to have low lymphocyte counts, which is associated with increased covid-19 severity. thus, individuals who died of covid-19 have been shown to have significantly lower lymphocyte levels than survivors. there is evidence that myeloid cells play a role in the pathophysiology of coronavirus infection, either directly as virus targets or indirectly as effectors of cytokine release syndrome. monocytes are innate hematopoietic cells that maintain vascular homeostasis and provide early responses to pathogens during acute infections. the role of monocytes and macrophages in the resolution of inflammation has also been emphasized as an important component of the response to sars-cov-2. accordingly, it was investigated whether the change observed in blood monocyte levels was an effective parameter in the prognosis process in covid-19 cases with lymphopenia, considering that monocyte levels could be useful as a guide in the course of the disease.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 * male and female of both genders * admitted to the intensive care unit * diagnosed with covid-19 with lymphopenia * patients with confirmed covid-19 diagnosis in polymerase chain reaction (pcr) tests performed on nasopharyngeal swab samples exclusion criteria: * those with a negative pcr test * aged 18 and under
clinical study to investigate the safety and performance of the virtuoso phaco-vitrectomy device

Conditions: Cataract; Vitrectomy; Vitrectomy Operation Under General Anesthesia

Summary: this is a pre-market clinical investigation with a device that does not bear the ce-marking. aim of the study is to confirm the safety and performance of the device and collect user feedback.

the virtuoso® dual advanced vision solutions system is a multifunctional phacoemulsification-vitrectomy system consisting of equipment and accessories for use in ophthalmic surgeries. the system is indicated for both anterior segment (i.e. phaco-emulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. in this study, the system is used within its intended purpose. study participants will undergo a routine vitrectomy procedure, cataract procedure or combined procedure, depending on their medical needs, using the investigational phaco-vitrectomy system. data will be collected on the use and functioning of the device, the ability to complete procedures with the device according to the standard of care, and clinical safety and performance outcomes.

Eligibility criteria:
inclusion criteria: * primary or repeat vitrectomy (only applicable to patients scheduled for vitrectomy or combined procedure) * patients aged ≥ 18 years * willing and able to provide written informed consent for participation in the study * willing and able to comply with scheduled visits and other study procedures. exclusion criteria: * patients aged \< 18 years * no post-operative 90 days visit is anticipated * patients requiring or having already had scleral buckling * patients with ocular comorbidities affecting surgical view including corneal opacities or scar * pre-operative endothelial cell count \<1500 cells/cm2 (only applicable to patients considered for the cataract subgroup or the combined surgeries subgroup) * advanced and secondary glaucoma * history of intraocular inflammation * untreated diabetes * microphthalmos or macrophthalmos * participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial. * post-traumatic eye * subluxated lens * morganian cataract * weak zonules: zonuli lysis or zonula laxa manifest * pregnant or nursing females

Keywords: vitrectomy device vitrectomy vitrectomy surgery cataract surgery
prediction of 18f-fes-pet/ct parameters on palbociclib combined with et

Conditions: Metastatic Breast Cancer

Summary: to investigate parameters based on 18f-fes-pet/ct so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with hr+/her2-mbc.


Eligibility criteria:
inclusion criteria: 1. female patients aged 18-70 years. 2. metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage iv breast cancer, and recurrent metastatic breast cancer. 3. hr+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry. 4. her2 status was determined by immunohistochemistry or fluorescence in situ hybridization. 5. palbociclib treatment of metastatic breast cancer for at least one cycle. 6. available medical history. exclusion criteria: 1.incomplete medical history.